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This year, MobiHealthNews covered many digital health milestones, including four IPOs, about $2 billion in funding, 33 merger and acquisition deals, and the entry of some big name companies in the space. But, this year also included some important moves by the FDA and, as always, a number of FDA clearances for digital health apps and devices.
In August, the FDA proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process. These devices included thermometers, smart body scales, stethoscopes, and some ophthalmic cameras.
Still, there were many devices that did get clearances this year — by MobiHealthNews’ with battery such as Welch Allyn 00185-2 Battery, Welch Allyn AED 10 Battery, Welch Allyn Atlas 622SO Battery, Welch Allyn Atlas 622SP Battery, Welch Allyn Atlas 622NO Battery, Welch Allyn Atlas 622NP Battery, Welch Allyn 5300 Battery, Welch Allyn 300 Battery, Kangaroo Battery, Kangaroo 224 Battery, Kangaroo 324 Battery, Kangaroo K524 Batterycount there were at least 31 new FDA 510(k) clearances for digital health.
Devices cleared this year include an app that uses the iPad’s camera to estimate the amount of blood lost during a surgery, a smartphone-connected thermometer, an iOS application that treats a medical condition called tinnitus, and a vitals sensing chair. There was even one mysterious clearance from South Korean technology company LG Electronics for something called “LG Smarthealth”.
Here are the 31 digital health FDA clearances from 2014:
New York City-based Kinsa Health received FDA 510(k) clearance for its Kinsa smart thermometer, which can be used, orally, under-arm, or rectally. The device transmits data to a companion smartphone app.
Samsung’s S Health app received 510(k) clearance from the FDA as a cardiology signal transmitter suggests that the clearance will allow S Health to interface with additional connected medical devices in the United States.
The FDA cleared the second generation of Waltham, Massachusetts-based EarlySense’s passive and contactless bedside monitor, which continuous measures respiration rate, heart rate and motion. Among the changes to the system are more sophisticated management tools to help administrators better measure and track quality goals.
Alere Connect, formerly known as MedApps before it was acquired by Alere, announced FDA clearance for its latest home health hub, HomeLink.
A British company, Camntech, received FDA clearance for a motion-tracking wristband and a wristworn electronic diary, likely for use in clinical trials. The devices are called the MotionWatch 8 and PRO-Diary.
Carestream received FDA clearance for VUE Motion, a mobile radiology viewing and reading software that can be accessed on iPhone 4s, iPad 2, Galaxy Note and Galaxy S III mobile devices.
Remote patient monitoring company HealthInterlink received FDA 510(k) class II clearance for Beacon 2.0, a mobile-centric software system that integrates data from various home health devices. Beacon was previously classified as a class I medical device (MDDS). By year-end news emerged that Welch Allyn had acquired HealthInterlink’s assets.