|
|
<p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">2016年上半年，FDA总共批准了18家公司的新医疗器械并且出台了一些关于医疗器械生产厂商如何将他们的数据向患者公开的新规。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">那么今年截至目前FDA都批准了哪些新产品呢？请看我们的年中大盘点：</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">1. Yugo微软Kinect理疗系统</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><img title="2.jpg" class="" data-type="jpeg" data-ratio="0.59375" data-w="640" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjPm9NEAw4fhOn0BON6pDW0JBJicAuTT4C3ia2YSNpSnnibCP1N8bTGP5eA/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">以色列初创公司Biogaming的产品——Yugo微软Kinect理疗系统通过了FDA认证。理疗师可以用这个系统为患者量身定制游戏化理疗方案，患者可以在家中用Xbox或者一台电脑与Kinect设备连接。这个系统可以记录患者的运动数据，自动建立一个治疗记录。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">2. Dario血糖仪</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="3.jpg" class="" data-type="jpeg" data-ratio="0.7951807228915663" data-w="498" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7Nj0z3TcQK5lAmqNts0ZyqaXN1oXb3jU6f2yEU8CvwVBUp0dIKm3iarffQ/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">另一家来自以色列的公司Labstyle Innovations的产品Dario——一个与智能手机结合的血糖仪也通过了FDA认证。这个血糖仪可以与一个附属app同步，并且体积袖珍可以随身携带。Dario由一个血糖测量仪、一个一次性测试条盒和一个穿刺装置组成。和它同步的app在iOS和安卓的应用商店都已上架，其中包括一个营养指南、日记本和监测系统。这个app可以让用户看的自己所有的信息，并根据信息的模型得到一些深度分析。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">3. Triggerfish互联隐形眼镜</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="4.jpg" class="" data-type="jpeg" data-ratio="0.835" data-w="600" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjH9tsRVComSPDNBQ3jQibZniaMpKMvIJ5V4Q0LUayCLIDmib7fkMEXvNoA/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">来自瑞士的公司Sensimed宣布他们的产品Triggerfish互联隐形眼镜获得了FDA的批准。这个隐形眼镜可以帮助医生记录青光眼患者的病情进展。植入了传感器的镜片可以24小时连续记录眼尺寸变化。这些数据是通过镜片无线传输到一个记录仪中的，患者可以在脖颈处佩戴这个记录仪。记录周期结束后，数据可以从记录仪中通过蓝牙转移到医生的电脑里——意味着患者需要到医生的办公室去上传数据。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">4. MoMe Kardia远程患者监控系统</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="5.jpg" class="" data-type="jpeg" data-ratio="0.509375" data-w="640" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjBo5j4lJ2sJqqFbPAg3HVuBEBTjNZo9oCFkDesskWXlzD9cQ7Uibicuxw/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">来自于马萨诸塞州洛厄尔市的InfoBionic公司的产品MoMe Kardia——一个远程患者监控系统，通过了FDA的认证。MoMe Kardia可以通过检测患者的心电图、呼吸和运动来探测心律失常。这个设备小而轻，可以作为项链或皮带附件佩戴。他们的第一代产品很早就通过了FDA认证，但是迟迟没有上市。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">5. Quell可穿戴止痛仪</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="6.jpg" class="" data-type="jpeg" data-ratio="0.7486033519553073" data-w="537" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjewPjyb5Cgj9vExsYibyH2K57sIYrbaPgbz3eNibuicXkPzMQngwDoEuRw/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">Neurometrix公司的产品Quell——一个通过智能手机控制的可穿戴缓解疼痛装备通过了FDA批准。其原理与它的初代产品相同，即通过刺激神经使大脑释放出自然阿片肽来缓解慢性疼痛。这个设备是佩戴在小腿肚上。新一代产品可以让用户直接控制他们的神经刺激。他们可以自由开关或者增减治疗强度，并在两种不同的被认证的治疗模式直接切换。这两种模式分别是常振模式和脉冲模式。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">6. Wing袖珍肺测量仪</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="7.jpg" class="" data-type="jpeg" data-ratio="0.7668488160291439" data-w="549" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7Njk2f9tG0jIwXmiaBQDMEdwHPgCuRpqmeCQS3PjDcoI9edG0hgeCsZ3HQ/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">来自密苏里州圣路易斯的公司Sparo Labs开发了一个app控制的肺活量计Wing，通过了场外交易认证，意味着公司可以直接向消费者销售这个产品，不过他们也很重视医院和药房的通路。Wing旨在帮助有哮喘和其他呼吸疾病（包括慢性阻塞性肺病和囊性纤维化）的患者，通过一个袖珍的传感器和相对应的app来监控肺功能。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">7. Smart Pump智能泵奶器</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="未标题-10.jpg" class="" data-type="jpeg" data-ratio="1.2514285714285713" data-w="350" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjJWp6fpwq9BanFdS2ibFtT2pEcibETicGqKBNGVJADEAarFLoFwSl0jLGw/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p data-find="_8" style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">位于加州红木城的初创公司Naya Health推出了智能手机控制的智能泵奶器——Smart Pump，通过了FDA认证，也成为了FDA史上第一个认证的泵奶器。Smart Pump使用一个液压系统而不是空气泵系统来获取母乳。公司称相比于空气泵，这个泵奶器使用更舒适、更安静。通过泵奶器收集的数据，例如妈妈泵奶的频率，可以传送到对应的手机app Naya Health Tracker中。这个app也可以让用户保存泵奶记录，记录婴儿的喂食，并通过告诉用户应该优先摄入怎样的食品来帮助产奶。这个公司同时还在开发一款Apple Watch的app。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">8. Withings Thermo体温计</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="8.jpg" class="" data-type="jpeg" data-ratio="0.988" data-w="500" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjGdZOsnjqiatsxqy3fa7EEHswzJZfv3XOK146kFo8pyeDhs0m2uIYMoQ/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">法国的互联设备制造商Withings最近刚刚被诺基亚收购。他们的产品Withings Thermo——一个wifi连接的体温计通过了FDA认证（我们对此有过报道）。这个产品最初是在今年1月的拉斯维加斯举办的电子消费展上面世的。取代传统的入口式或腋下体温测量，Thermo通过测量额头颞动脉温度来测量体温。用户只需将体温计放在他们或孩子的额头上，16个独立的传感器就会通过红外线测量体温。读数可以在体温计侧面显示，并且可以直接传送到对应的手机app中。用户可以进行个人记录或多人记录，并附注点评。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">9. Trak男性生育力测试仪</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="9.jpg" class="" data-type="jpeg" data-ratio="0.7464788732394366" data-w="568" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjriaQJxHb11JfORSxS0icmTib3GEsso0JFCYpVZrWOj7IyrMCQxicPhZFrQ/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p data-find="_1" style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">Sandstone诊断公司的Trak系统通过了FDA认证。这是一个通过app连接的家庭男性生育力测试系统。Trak的设备旨在打破现今的被许多人认为是奇怪且不便的衡量男性生育力的模型。这个设备作为2类医疗器械已经通过了场外认证。这个设备通过一个离心机在一个特别设计的试剂盒中将精子细胞分离出来。然后通过手机app以世界卫生组织的指南为标准分析，告诉用户测试结果——精子数是过低、适量还是最优。这个app不仅能告知用户他们的精子数，并且可以让他们与人群总平均值（来自于用户收集的数据）相比较，并给出个人定制的可能能帮助他们改善的健康和生活方式建议。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">10. QbCheck多动症辅助工具</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="未标题-11.jpg" class="" data-type="jpeg" data-ratio="0.4828125" data-w="640" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjTNXAoz7vaTBYocfzQwqT4EJlZ8aTxWS03O2a3icicK5gcytY171GhDBA/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">瑞典的公司Qbtech的产品QbCheck通过了FDA认证。这是一个在线工具，可以为多动症儿童的诊断和治疗提供决策支持。据公司称，通常的多动症诊断过程十分复杂，包括很多管理支出和偏向性风险。Qbtech的流程旨在帮助多动症更容易地被发现、排除和治疗。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">11.AVIVO移动患者管理系统</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="未标题-12.jpg" class="" data-type="jpeg" data-ratio="0.47217537942664417" data-w="593" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjicL3l3xfOTOewZPPXTwLRZg6Q7lG7MlrmiahqDjKEdMK7OFtmAtlQ3tQ/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">美敦力公司的产品AVIVO移动患者管理系统通过了FDA认证，这个系统可以连续检测和记录心脏病患者的数据，并周期性传送数据。这个系统采用一个可穿戴传感器，而数据记录器由患者操作，将信息传送到美敦力的服务器中。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">12. Jazz无线血糖监测系统2</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="10.jpg" class="" data-type="jpeg" data-ratio="0.64" data-w="500" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjbZF4pWibZRrzrpl3yiaHT5sOA5zEWXlToOZM5Xjp43icTvgk55XcLzurQ/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">位于新罕布什尔州Salem市的公司AgaMatrix的无线血糖监测系统获得了FDA认证。这个设备以及它附带的app的名字是Jazz无线血糖监测系统 2，是基于之前一个通过FDA认证的设备推出的新产品，可通过蓝牙与iOS和安卓设备连接。开始检测后，用户在5秒之内就可以拿到结果，同时与app同步，并且可以与家人或医生共享数据。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">13. Dyna-Vision远程监控系统</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="未标题-13.jpg" class="" data-type="jpeg" data-ratio="0.5205724508050089" data-w="559" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjViaMLicHscl39FEtAobFEzFz2d80WiaoibibfIxYQLFeEicArdAiaYzckfQRg/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">位于荷兰阿姆斯特丹的公司QServe Group的产品Dyna-Vision远程监控系统获得了FDA认证。这个系统使用Dyna-Vision设备来监控心血管监控，然后将数据传送到系统服务器中。然后这些数据可以通过wifi或3G传送到远程监控软件中，并与手机app相连。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">14. LifeWatch迷你心电图监控器</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="未标题-14.jpg" class="" data-type="jpeg" data-ratio="1.3133333333333332" data-w="600" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjAWQLm3Be5Mg7e2ORKPslIfSCwqoQkhZ8eI0DezGGeqFakdblwpwtYg/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">LifeWatch科技公司的迷你心电图监控器和心律失常探测器在今年一月获得了FDA认证。虽然这个仪器没有与智能手机连接，这个单导联心电图补片可以通过蜂窝连接将数据传送到监控中心。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">LifeWatch的对另一个在2014年12月通过认证的产品Vital SignsPatch （VSP）也进行了更新。这个设备是一个包含检测传感器的一次性胶条，可以测量心电图、心率、呼吸频率、体温、血氧饱和度和运动等数据。它还包括一个电池，使连续收集数据的续航能力可以达到5~7天。它还带有一个无线连接的血压袖带和一个安卓app，可以处理和传送数据。这个app还可以监测患者健康情况，并可以在出现非正常信号时发出警示。据一份总结文件陈述，这次更新可以让这个设备与临床顾问平板电脑连接，并且添加了一个“患者姿势感应器”设备。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">15. iHealth血压记录监测仪</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="未标题-15.jpg" class="" data-type="jpeg" data-ratio="0.584375" data-w="640" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjbG6jOJWuHSHe40xricMseTMbEGrbFVQ5wr3Fcibym0Ox4FzCW5YQlrag/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">iHealth Labs的母公司Andon Labs的产品iHealth血压记录监测仪在2月获得了FDA认证。这是一个新型可与手机连接的血压袖带。它与之前通过认证的一个设备非常相似，报告说，“不同之处只有外观、存储空间大小、电源、测量处理、平均测量函数和微控制器这些方面，同时还有一个新增的软件平台。”</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">16. 宝莱特蓝牙体温计</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="未标题-16.jpg" class="" data-type="jpeg" data-ratio="0.7061611374407583" data-w="633" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjIuzjwfxTRodc6peRgzZOCSBJrxniaTEZxB46bOPbrfOIiahfGd8I7qAg/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">来自广东的宝莱特公司的无线连接温度计产品在1月获得了FDA认证。这个带有电池的手持设备可以通过入口式或腋下测量体温，并通过蓝牙将数据传送到iOS或者安卓设备上，与app Temp Sitter同步。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">17. 泰博蓝牙血氧仪</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="未标题-17.jpg" class="" data-type="jpeg" data-ratio="0.6930379746835443" data-w="632" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjeAOYRjLDA7D0iba7kvzFALtLbnulJWluiboB4lrHuYlygqXAicPCKaMIw/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">来自台湾的泰博公司的产品——蓝牙血氧仪在3月通过了FDA认证。这个产品是泰博公司制造的一个大型互联设备系统的成员之一，是泰博远程医疗系统的组成部分。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">18. Propeller智能吸入器</strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; text-align: center; box-sizing: border-box !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img title="未标题-18.jpg" class="" data-type="jpeg" data-ratio="0.9266666666666666" data-w="300" width="auto" src="http://mmbiz.qpic.cn/mmbiz/CHGhJQqYmBhh9pTGu3b54CAJmZ6icH7NjMUnzgxNJXdUHcMia6Aullicib9tHaibOAIz66ORYts9bVylJx32O8OZaAQ/640?wx_fmt=jpeg" style="max-width: 640px; border: 0px; vertical-align: middle; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">Reciprocal labs旗下的Propeller Health，这家公司通过FDA认证的产品是带有Propeller传感器的智能吸入器，包括附属的app。这个设备可以为哮喘病人带来极大的便利。</p><p style="margin-bottom: 29px; max-width: 100%; word-wrap: break-word; min-height: 1em; white-space: normal; line-height: 28px; color: rgb(34, 34, 34); font-family: 'Microsoft YaHei', Helvetica, Arial, sans-serif; box-sizing: border-box !important; background-color: rgb(255, 255, 255);">本文原创首发机构MyBioGate微信平台，是发布美国医健行业创新、创业、投资动态，美国医健发展深度研究与分析，美中跨境合作重要活动信息为主的微信平台。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; font-size: 14px; line-height: 24px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(249, 249, 249);">广州市设备维修有限公司</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">地址：广州市天河区银利街银利茶叶博览中心E栋4楼E4030室 邮编：510507</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电话：(+86)020-8722 8723 8764 5360 8764 2943 传真：020-8722 8623</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">全国统一免费服务热线：400-020-6788</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">微信公众帐号：</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1" data-type="jpeg" data-w="120" width="auto" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/640?wx_fmt=jpeg" style="box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">维修咨询：QQ: 712638 404</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">设备咨询: QQ: 712638 405</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">软件咨询：QQ: 712638 406</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">配件咨询：QQ: 712638 407</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">交流Q群：1106 11074</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">网址：http://www.yiliaoshebeiweixiu.com</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电子邮箱：service@yiliaoshebeiweixiu.com</span></p><p style="line-height: 1.75em;"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br /></span></p><p><br /></p>
|
|
发表于 2020-10-19 23:51:15