FDA 510(k)

By Jonah Comstock September 28, 2016
Abbott has received FDA Clearance for its FreeStyle Libre Pro system, a key milestone in bringing the company's unique take on the continuous glucose monitor to the United States. In Europe, where the system has had CE Mark clearance since September 2014, there is both a prescription and over-the-counter version available and the latter is smartphone compatible. "FreeStyle Libre Pro transforms...
By Jonah Comstock August 9, 2016
The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices. Lack of regulatory clarity is often cited as a force hampering innovation in digital health, so these moves by the FDA toward greater clarity are likely to be welcomed in many parts of the industry....
By Heather Mack July 21, 2016
We’ve compiled a list of our FDA-related coverage for first half of 2016. Eighteen companies received clearance for their devices, one was declined, and one group of patients published an editorial about their relationship with the FDA. Also this year, the FDA came out with some new guidance about how medical device makers should make data available to patients. Read on for our roundup of...
By Jonah Comstock July 12, 2016
Analytica's PeriCoach, a smartphone-connected Kegel exercise coach for women, has received a second FDA 510(k) clearance, one that allows it to be sold over-the-counter. Its previous clearance, from March of last year, was for prescription use only. “This is a terrific achievement for Analytica which opens up a significant market opportunity within the United States, and also positions us...
By Jonah Comstock June 29, 2016
Withings, the French connected device maker recently acquired by Nokia Technologies, has received FDA 510(k) clearance for Withings Thermo, the company's WiFi-enabled thermometer, MobiHealthNews has learned. The device was first announced in January at CES in Las Vegas. Rather than being inserted in the mouth or armpit, Thermo measures temperature from the temporal artery on the user's forehead....
By Jonah Comstock February 10, 2016
BioGaming, an Israel-based startup, has received FDA clearance for its YuGo Microsoft Kinect-based physical therapy system. Calls to the company for comment went unanswered and its website appears to be down.  Physiotherapists can use the system to create personalized gameified routines for patients which patients can then complete at home using an Xbox or a computer connected to a Kinect device...
By Aditi Pai December 15, 2015
China-based Viatom Technologies has received FDA 510(k) clearance for Checkme Pro, a connected medical device that tracks a number of vital signs, according to Medgadget. The small Checkme Pro device includes an ECG that tracks heart rate, QRS duration, ST segment, and rhythm analysis, a pulse oximeter, an activity tracker, a thermometer, and a sleep monitor. The device can be set to a hospital...
By Aditi Pai December 2, 2015
Philosys has received an FDA 510(k) clearance for the Android version of its smart glucometer companion app, called Gmate Smart. The device now works with Samsung Galaxy S3, S4, and S5 devices that have an Android operating system 4.0 or higher as well as Apple iPhone, iPod Touch, and iPad with iOS version 5.0 or higher. Philosys received an FDA clearance for the iOS app last year, in August, but...
By Jonah Comstock November 17, 2015
Visible Patient, a French company that makes 3D models of human organs to assist surgeons, has received FDA 510(k) clearance for its VP Planning Software Suite. The software suite has had a CE Mark for six months and has been commercially available in Europe for a year. Via the software, surgeons send radiological data like CT and MRI scans to Visible Patient. In-house designers create 3D models...
By Jonah Comstock October 12, 2015
A smart baby bottle, which uses sensors to measure a baby's tongue strength and sends the data to a provider's mobile device, has received FDA clearance. Atlanta, Georgia-based NFANT Labs, formerly known as CCB Research Group, has been working on the system for about a little under two years. "Many infants in the NICU have trouble transitioning from tube feeding to bottle or breast feeding and...