Digital health's busy summer for FDA clearances

By Brian Dolan
04:40 am

Brian Dolan, Editor, MobiHealthNewsAugust is not yet half over and already the FDA has had a busy summer.

In recent weeks MobiHealthNews reported on the FDA's de novo clearance of Proteus Digital Health's intelligent medicine platform and Asthmapolis' inhaler sensor and companion software. As we noted early last month, the FDA granted 510(k) clearance to a variety of digital health companies in June, including the app-enabled toothbrush from Beam Technolgies, a Bluetooth-enabled blood pressure monitor from iHealth, a surgical sponge management app from Gauss Surgical, and a WiFi-enabled weight scale from China-based ShenZhen. (For more details on these, see our round-up of June 510(k) clearances here.)

In July the agency granted 510(k) clearances to at least a half dozen mobile health companies, including Vignet, Constant Care, Watermark, iHealth, AirStrip Technologies, and iRhythm.

The 510(k) clearances from AirStrip and iRhythm appear to be just another in the series of clearances each company has accumulated for its products. AirStrip already has a handful of 510(k) clearances for its smartphone and tablet based remote patient monitoring (RPM) suite of applications. (The summary details on the latest add-on 510(k) for AirStrip can be viewed here.) Similarly, iRhythm added another clearance for its Zio patch, which has so far bucked the connectivity trend and instead stores heart data that patients transmit to a care center by physically mailing the cardiac monitoring device after wearing it for a period of time.

Vignet, Watermark, and Constant Care each had home health offerings cleared by the FDA in July.

Vignet's TeleHealth Manager received Class II 510(k) clearance from the FDA last month. The software works with a variety of already cleared external biometric measuring devices, according to the company, including blood pressure devices from A&D and Fora Care, weight scales from A&D and Omron, glucose meters from Entra Health Systems and Fora Care, a pulse oximeter from Nonin Medical, a pedometer from Omron, a thermometer from Fora Care, and a peak flow meter from Vitalograph. The company's software system collects the physiological data "for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols." Patients can also view the data "as an aid in maintaining wellness regimens," the company stated in its FDA filing. Vignet's iPhone app was the first one to gain certification from interoperability group Continua Health Alliance in March of this year.

Like Vignet's telehealth offering, Constant Care's LILAH Home Health Monitoring System is software that collects data from various external biometric devices. Constant Care's offering has two components, according to the company: The patient-side software that is installed on an Asus EeTop PC or an Acer tablet PC and transmits data to the caretake portal online, and the caregiver-side software online. The system "provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and real-time video conferencing technology," according to the FDA filing. It works with wired and wireless glucose meters, weight scales blood pressure monitors, medication reminders, and pulse oximeters.

Watermark also received 510(k) clearance for software that acted as a home health hub: Watermark's Connected Care Mobile Application receives, displays, and transmits patient information "on a retrospective basis" -- not in real-time or in emergency situations. The mobile app is designed to work on various platforms, including tablet computers and smartphones, according to the filing. The app helps users collect vital signs data from Bluetooth-enabled medical peripherals, including weight scales, glucose meters, blood pressure devices, and pulse oximeters.

Finally, Andon Health, which counts iHealth Lab as a subsidiary, received clearance for a WiFi-enabled weight scale. Currently, the company only offers a Bluetooth-enabled weight scale through its iHealth subsidiary.

If the agency keeps up this pace in August, we expect another half dozen devices and apps that the FDA considers to be medical devices to announce clearance this time next month.


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