FDA 510(k)

By Jonah Comstock June 8, 2017
iRhythm Zio is in many ways a poster child for a connected health company. The company, which makes a peel-and-stick patch for mobile ECG recording, is one of the few wearable medical device companies to go public, and few digital technologies have as soundly improved on the status quo as Zio has on the Holter monitor, a long-term legacy monitoring technology. There's only one problem with...
By Jonah Comstock June 6, 2017
San Diego-based Clarify Medical has received FDA 510(k) clearance for its core technology, a handheld, smartphone-connected phototherapy device for treating various skin conditions.  “This is a major milestone,” CEO James M. Sweeney said in a statement. “We look forward to offering Clarify Home Light Therapy to patients throughout the country, beginning in November. It offers an in-office therapy...
By Jonah Comstock May 16, 2017
Ashkelon, Israel-based Oxitone Medical has received FDA clearance for a wristworn pulse oximeter that doesn't require a finger clip. According to the company, the device – the Oxitone 1000 – can pick up SpO2 and pulse rate with the same accuracy as traditional fingertip pulse oximeters. The device has a consumer-friendly form factor, but Oxitone is targeting the clinical market. The design of the...
By Jonah Comstock May 16, 2017
Swiss neurogaming company MindMaze has received FDA clearance for its MindMotion Pro platform, a motion capture system similar to the Microsoft Kinect which can be used in rehabilitation of stroke and traumatic injury patients. "In the last few years we’ve launched products at the intersection of the brain and VR," MindMaze CEO Tej Tadi told MobiHealthNews. "What we’ve done today very...
By Jonah Comstock May 5, 2017
The FDA granted a second 510(k) clearance this week to CareTaker, a Charlottesville, Virginia connected medical device company. CareTaker's device of the same name is a wearable, connected blood pressure and heart rate sensor that originally received clearance this time last year. “CareTaker is a real game changer, allowing physicians to remotely monitor medical-grade continuous blood pressure...
By Heather Mack April 18, 2017
Dublin, Ohio-based Monitored Therapeutics, Inc. (MTI) has received FDA 510(k) clearance for its connected spirometer, GoSpiro. The device, which calculates diagnostic-quality air capacity measurement, was designed specifically for use in a non-clinical setting. As calculations are performed inside the device, GoSpiro can work with any smartphone, tablet or computer without the need for separate...
By Jonah Comstock January 31, 2017
VivaLnk, a Santa Clara-based connected health startup, has received FDA clearance for its first device, a peel-and-stick continuous thermometer for children called Fever Scout. VivaLnk announced Fever Scout at CES 2015 and originally planned to launch it that year, but has delayed the launch more than once. FDA clearance could mean the device will finally hit the market soon. Update: VivaLnk...
By Heather Mack December 30, 2016
Over the past year, MobiHealthNews has covered 36 devices that received clearance from the Food and Drug Administration. While connected blood glucose monitors and devices incorporating heart rate sensors dominate the list, we also saw more apps and software clearances, as the regulatory agency continues to evolve its position and expertise on how to regulate digital health tools. It’s been an...
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...