FDA clearance

By Aditi Pai August 20, 2014
New York City-based medical device maker Philosys received FDA 510(k) clearance this week for its smartphone-connected glucose meter, Gmate Smart. To use the Gmate Smart glucometer, users launch the device's connected app, plug in their Gmate glucometer through the audio jack, insert a test strip into the glucometer, add a blood sample, and view results on the app. Gmate Smart's app is only...
By Brian Dolan June 2, 2014
New Zealand-based medical device company Nexus6 has received FDA clearance for its smartphone-connected inhaler, SmartTouch, as a class II medical device. The new SmartTouch device has been cleared as a prescribable Metered Dose Inhaler (MDI) with a handful of intended uses: in clinical trials; in clinical practice, and for patient self-management. In all cases the device is used to help track...
By Aditi Pai May 29, 2014
Atlanta, Georgia-based health device maker CardioMEMS received FDA clearance for its CardioMEMS HF System, which monitors pulmonary artery pressure, but for patients who have experienced New York Heart Association (NYHA) Class III heart failure and have been hospitalized for heart failure in the previous year. After the small sensor is implanted into the pulmonary artery, which is a blood vessel...
By Brian Dolan May 20, 2014
Medical device giant Medtronic is in the final stages of acquiring peel-and-stick medical sensor company Corventis for north of $150 million, MobiHealthNews has learned. While neither company has publicly commented on the deal, it is expected to be officially announced some time in the next few weeks. (Update: I've heard conflicting reports from sources on the price of the deal since publishing...
By Brian Dolan March 5, 2014
Last week South Korea's health regulatory agency, the Ministry of Food and Drug Safety (MFDS), announced that it would review the latest version of Samsung's Galaxy phone -- the S5 -- to determine whether the device, which includes a built-in heart rate sensor -- should be regulated as a medical device. According to a local media report from Yonhap, the agency defines medical devices in a similar...
By Brian Dolan February 25, 2014
Telcare's Blood Glucose Monitoring System Verizon recently received its second FDA clearance for its converged health management software platform, which MobiHealthNews first wrote about last August. While the intended use cases and overall technical aspects of the system haven't changed, Verizon has added support for Telcare's cellular-enabled blood glucose monitoring system and Genesis...
By Brian Dolan February 11, 2014
San Francisco-based AliveCor announced that the FDA has granted its smartphone-enabled, single-channel ECG (electrocardiogram) recorder device over-the-counter (OTC) clearance. The company is now taking direct-to-consumer preorders for the device at a $199 pricepoint. It expects to begin shipping them in early March. Up until now the AliveCor device has only been made available to physicians and...
By Jonah Comstock February 10, 2014
A British company, Camntech, has 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. According to the filing, the devices "are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep." The devices upload data to a PC...
By Brian Dolan January 13, 2014
Vocera Communications announced this week that it had acquired alarm management company mVisum for $3.5 million. Vocera has yet to respond to a request for additional comment. Notably, in April 2013 mVisum settled a lawsuit filed by competitor AirStrip Technologies, which alleged mVisum had infringed on its patents for remote monitoring of patient medical data on smartphones. As part of the...
By Brian Dolan January 13, 2014
This month 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. "One of the very strong attributes of our technology and...