FDA 510(k)

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...
By Neil Versel 01:58 pm November 28, 2012
AFrame Digital, a Reston, Va.-based maker of telemonitoring technology, has received 510(k) clearance from the FDA to sell its MobileCare Monitor as a Class II medical device in the US. The company has had less-stringent Class I approval for its flagship monitoring product since 2009. MobileCare Monitor is a wristwatch-like device that offers continuous, real-time monitoring for seniors, people...
By Jonah Comstock 10:39 am November 16, 2012
A Beijing-based medical device company called Raiing has been granted 510(k) FDA clearance for the Raiing Wireless Thermometer, a peel-and-stick contact thermometer sensor that continuously transmits body temperature readings to a companion iPhone app, which is already available in the iOS AppStore. The app is called Vitals Monitor and is currently available for a free download, but the device...
By Brian Dolan 04:23 am September 11, 2012
Minneapolis-based Preventice announced this week that the FDA had cleared its remote monitoring device for patients with cardiac arrhythmias, the BodyGuardian Remote Monitoring System, with a 510(k) clearance. Preventice developed the system with its partner Mayo Clinic and licensed technology from Proteus Biomedical's partner Avery Dennison for the peel-and-stick sensor. BodyGuardian is a small...