FDA 510(k)

By Jonah Comstock 11:07 am March 25, 2015
Vital Art and Science, developers of myVisionTrack, a vision test service for patients with age-related macular degeneration or diabetic eye disease, has received a second FDA clearance for their platform, which includes an app and a provider dashboard. They will also soon launch a major clinical trial in partnership with the Scripps Translational Science Institute and Roche, according to the...
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 Jonah Comstock 09:15 am December 1, 2014
South Korean technology company LG Electronics has received an FDA 510(k) clearance for something called "LG Smarthealth". The move indicates that LG might be playing catch-up with electronics competitor Samsung, which received a similar clearance for its S Health app last year. While there is no reference to LG Smarthealth on the company's website, several of LG's G3 smartphones do sport LG...
By Aditi Pai 10:09 am June 20, 2014
San Francisco-based Qardio received FDA 510(k) clearance recently for its connected blood pressure monitor, called QardioArm. The device will be available for $99 next week on Qardio's website an in select stores. Qardio, which debuted its blood pressure and heart rate monitor at CES, aims to not only be accurate, but also beautiful, so that it fits into the user’s daily life. According to Qardio...
By Brian Dolan 07:35 am February 12, 2014
Image from the office of Senator Deb Fischer (R-Neb.) Longtime MobiHealthNews columnist Bradley Merrill Thompson, a member of the lawfirm Epstein, Becker & Green, and one of the founders of the mHealth Regulatory Coalition and the CDS Regulatory Coalition, sent over a few examples of the types of apps that a bill in Congress, called the PROTECT Act, would instruct the FDA to stop...
By Brian Dolan 05:26 am July 23, 2013
Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urine analysis system, has already had a busy year. Its cofounder appeared onstage at TED. Its uChek system was held up as an example of FDA's lack of enforcement in a Congressional hearing in March. The FDA subsequently took the rare action of sending the company a warning letter about uChek that...
By Brian Dolan 05:06 am June 11, 2013
Starting next month Medicare patients with diabetes who receive their diabetes testing supplies via mail order may or may not notice any changes, but after negotiating prices down, CMS is set to start paying the mail order diabetes supply companies about 20 cents per strip beginning July 1. Glooko CEO Rick Altinger told MobiHealthNews in an interview this week that the change is actually welcome...
By Brian Dolan 08:13 am 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...
By Jonah Comstock 01:52 am January 24, 2013
An iPhone app and peripheral device that allows doctors to use the iPhone camera to take photographs of the interior surface of the eye has received 510(K) FDA clearance. The iExaminer System from Welch Allyn will build on the company's existing PanOptic Opthalmoscope, a device that lets a physician see into the back of a patient's eye. The FDA clearance is for an adapter that connects the...
By Brian Dolan 04:00 am December 20, 2012
How many mobile medical apps have received 510(k) clearance from the FDA? It's a question I get asked often. For a while the standard response that I've given and heard others give was that you could count on two hands how many apps have received FDA clearance. Over the course of the past two years, however, it has become clear that an increasing number of wireless-enabled medical devices with...