July 8, 2013
Wexford, Pennsylvania-based Rijuven has received FDA 510(k) clearance for its CardioSleeve device, which turns a doctor's stethoscope into a mobile-enabled 3-Lead ECG device with digital auscultation. That is, it includes a clinical decision support system that helps doctors evaluate heart murmurs.
According to the company's website, with the CardioSleeve device attached, the stethoscope records...
May 23, 2013
So far this past week was a busy one for those at the FDA's device office focused on mobile medical app regulation. No, it didn't release its final guidance document yet, even though Congress gave the agency a verbal lashing more than three months ago now. Still, the agency has had an unusually busy week.
Apart from the typical -- like Rock Health alum Nephosity securing FDA 510(k) clearance for...
May 13, 2013
Minneapolis-based Preventice announced the commercial launch of its first hardware product: the BodyGuardian Remote Monitoring System. The device, a small sensor attached to the body via a peel-and-stick patch, received FDA 510(k) clearance in August 2012. BodyGaurdian RMS uses an algorithm developed by the Mayo Clinic, sensor technology from STMicroelectronics, and wireless technology from...
May 1, 2013
Proteus Biomedical's Raisin system
Redwood City, California-based Proteus Digital Health announced that it had raised $62.5 million in its latest round of funding led by Oracle with participation from existing investors Otsuka, Novartis, Sino Portfolio and others. MobiHealthNews reported on the first $17.5 million that Proteus raised for this round a year ago, so the $62.5 million includes an...
March 26, 2013
It's possible that folks in the industry can be a little too quick to call out signs of the times that mobile health has "gone mainstream" or "hit the big leagues." But there certainly have been some strong signs lately. Samsung announced mobile health features as a key part of its release strategy for the Galaxy S4. The House of Representatives hosted three days to holding hearings on mobile...
March 14, 2013
Novartis Oncology, a division of the Switzerland-based pharmaceutical company, has added two new free Apple and Android apps to its catalog: My NET Manage and Clinical Trial Seek. Interestingly, one of their most high-profile apps, VaxTrak, has now disappeared from the Apple and Google Play stores.
My NET Manager is an app for patients with neuroendocrine tumors (or NET) to help them manage and...
March 1, 2013
The Misfit Shine is an example of a partially passive wearable sensor.
The future of sensors won't be handheld devices like Star Trek's tricorder. It will be invisible sensors in your shoes, floorboards, and cars that quietly collect your health data, analyze it, and alert you, your doctor, or your loved ones only when something goes wrong. That's the prediction in "Making Sense of Sensors: How...
February 18, 2013
Perhaps more than any other metric, the time it takes to secure clearance is the one that gets the most attention for 510(k) devices. An updated analysis from medical device quality assurance and regulatory consultants, The Emergo Group, finds that the average time it took for a medical device to complete the 510(k) process was about 138 days in 2011, down from 146 days in 2010. The company...
January 18, 2013
Care4Today by Janssen Healthcare Innovation
For one reason or another, as many as half the patients in the United States don't take the medication that is prescribed to them at a cost to the US healthcare system of $290 billion a year in waste. That's according to NEHI, formerly known as the New England Healthcare Institute, which has been tracking the medication adherence problem for years....
August 14, 2012
August 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...