FDA 510(k) clearance

By  Jonah Comstock 10:28 am January 2, 2014
Samsung's S Health app For the first time, Samsung has received FDA 510(k) clearance for its S Health app. The categorization of the clearance as a cardiology signal transmitter suggests that the clearance will allow S Health to interface with additional connected medical devices in the United States. Samsung's S Health app originally launched for Galaxy S III users in the UK in the summer of...
By  Jonah Comstock 11:06 am December 5, 2013
The FDA has cleared the eMotion ECG Mobile, a Finnish continuous ECG monitor that connects to Android smartphones, as a Class 2 medical device. The ECG Mobile, made by Mega Electronics, already has a CE Mark and has been available for purchase in Europe since late 2012, but the company's securing of FDA clearance suggests it may be bringing the device to the United States to compete with mobile...
By  Jonah Comstock 06:19 am November 25, 2013
23andMe's app. In a public letter dated November 22, the Food and Drug Administration has instructed personal genome startup 23andMe to immediately stop selling its testing service until the offering receives de novo 510(k) clearance. Regulatory Focus first spotted the letter. "[M]onths after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not...
By  Jonah Comstock 05:00 am November 5, 2013
Intel-GE Care Innovation's QuietCare resident monitoring system has received FDA 510(k) clearance as a Class I device. The QuietCare system is a network of infrared motion sensors placed in a senior living facility, which sends data to a Care Innovations server. An algorithm on the server analyzes motion data for potentially urgent situations such as falls and for significant changes in the user'...
By  Jonah Comstock 02:30 am October 29, 2013
Diabetes tracking company Glooko, which offers a cloud-based logbook app and a cable that connects the iPhone to commercially available blood glucose monitors, has launched -- and received FDA 510(k) clearance for -- a new app and cable for Android phones. Glooko's new app will connect to the same cloud-based web dashboard as the company's iPhone app. That platform was FDA cleared in May and...
By  Jonah Comstock 11:09 am October 11, 2013
Sotera Wireless has received yet another FDA 510(k) clearance for its ViSi remote patient monitoring system, this time for its novel continuous noninvasive blood pressure (cNIBP) monitoring software. The technology, which enables continuous blood pressure monitoring without a cuff or catheter, has been part of Sotera's pitch from the beginning, but was not included in the company's April 2012...
By  Jonah Comstock 09:15 am October 7, 2013
iHealth's existing consumer pulse oximeter. iHealth Labs, a subsidiary of China-based medical device company Andon Health, has received FDA clearance for a wireless fingertip pulse oximeter, which will be a distinct offering from the consumer pulse oximeter the company announced at CES last year and currently sells on its website. "Basically we're coming out with an FDA-[cleared] version,"...
By  Neil Versel 11:08 am October 4, 2013
AliveCor, maker of a low-cost, smartphone-based ECG device for the iPhone, has gained FDA 510(k) clearance for a long-anticipated universal ECG attachment that works with just about any late-model Android or iOS smartphone or tablet, and is now available for sale in the US. The new AliveCor Heart Monitor, introduced Friday at the University of Southern California's seventh annual Body Computing...
By  Jonah Comstock 05:02 am August 6, 2013
The Alere INRatio2 PT/INR Monitor, which will connect to MobileLink. Alere Connect, the Alere subsidiary formerly known as MedApps, received FDA 510(k) clearance for its MobileLink system. The system is a cloud-based communication hub that connects a single remote monitoring device to its Connected Health platform, allowing data to pass between patients, providers and electronic health records...
By  Jonah Comstock 08:58 am July 8, 2013
EPI Mobile Health Solutions, a Singapore-based company, has received FDA clearance for a smartphone-enabled ECG device -- one which the regulatory agency refused to import last fall. The company claims on its website to be "the world’s first, patented Electrocardiogram ('ECG') function integrated onto a mobile phone," likely referring to its EPI Life mobile phone offering. EPI Mobile Health has...