FDA 510(k)

By Jonah Comstock November 21, 2016
Ascensia Diabetes Care, a business unit created this year when Panasonic Healthcare Holdings acquired Bayer Diabetes Care, has received FDA clearance for a second connected glucometer device, the Contour Next One. Its previous device, the Contour Next Link, was cleared in August. While the Contour Next Link was designed specifically to connect to a Medtronic insulin pump, the Contour Next One is...
By Heather Mack November 7, 2016
Madison, Wisconsin-based Propeller Health, maker of several smart inhaler sensors and companion apps, has received FDA 510(k) clearance for its latest offering – a sensor that works with GlaxoSmithKline’s Ellipta inhaler. This marks the company’s eighth FDA clearance, and was born out of a partnership the company struck up with GSK last December. Given Propeller's growing familiarity with the...
By Heather Mack October 31, 2016
Israel-based medical device maker TytoCare has received FDA 510(k) clearance for its digital stethoscope, joining the company's ecosystem of connected tools for remote medical examinations. The company also offers several FDA Class 1 devices –  a connected otoscope for ear examinations, a high-resolution camera, and a thermometer that uses the forehead to get a reading.  The stethoscope pairs...
By Jonah Comstock October 18, 2016
Phillips received FDA clearance for an additional transducer for its Lumify ultrasound system, a small portable ultrasound that can connect to mobile devices as well as traditional PACS. The newly cleared S4-1 transducer adds cardiac capabilities to the platform and allows physicians to conduct the focused assessment with sonography for trauma, or FAST exam, with the device. Lumify receved its...
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...

Editor's Pick