FDA clearance

The FDA has approved San Diego, California-based Dexcom for a Bluetooth-enabled continuous glucose monitor (CGM), called the G5 Mobile CGM system.

Last month, Roche quietly launched its Accu-Chek Connect app, a diabetes management app which contains, among other things, an unprecented feature: a prescription insulin bolus calculator called Bolus Advisor.

Theranos, the 12-year-old Palo Alto-based company working on a smaller, cheaper, alternative to common lab blood tests, has received its first voluntary FDA 510(k) clearance, for its herpes simplex 1 virus IgG (HSV IgG) test.

Proteus Digital Health has received an update to its FDA 510(k) clearance for its digital medicine platform, adding a new indication to the clearance.

In March, Roche received FDA clearance for its Accu-Chek Connect companion app, and, less than a month later, issued a recall of that app.

AliveCor's AF detection algorithm San Francisco-based AliveCor has received FDA clearance for two new algorithms for its smartphone-connected ECG: one that detects normality and one that detects interference.

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.

Vital Connect's HealthPatch, which partnered with LifeWatch last month Swiss remote cardiac monitoring company LifeWatch has received FDA 510(k) clearance for LifeWatch VSP (Vital Signs Patch), the company's adhesive patch for remote patient monitoring.

New York City-based medical device maker Philosys received FDA 510(k) clearance this week for its smartphone-connected glucose meter, Gmate Smart.

New Zealand-based medical device company Nexus6 has received FDA clearance for its smartphone-connected inhaler, SmartTouch, as a class II medical device.