FDA clearance

By Jonah Comstock 08:56 am April 9, 2015
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. App recalls, which are becoming more common as more and more apps receive FDA clearance, are less severe than device recalls because they can often be ameliorated with a quick software patch. The app, available only on Android at present, helps patients track...
By Jonah Comstock 04:02 am January 29, 2015
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. These follow up on AliveCor's atrial fibrillation detection algorithm that received clearance last fall. The Normal Detector assures patients that their ECG is free of abnormalities. If...
By Aditi Pai 06:28 am December 23, 2014
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...
By Jonah Comstock 09:39 am December 22, 2014
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. "Being small in size, easy to affix, comfortable to wear and far less restrictive and cumbersome than numerous wired devices currently used,...
By Aditi Pai 08:44 am 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 07:52 am 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 08:59 am 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 09:30 am 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 07:39 am 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 06:11 am 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...