FDA 510(k) clearance

By  Jonah Comstock 12:40 pm October 20, 2014
Dexcom Share, a cradle device that will allow users to send data from a Dexcom continuous glucose monitor to multiple smartphones, has received 510(k) clearance from the FDA. The system is designed to help parents and caregivers remotely track the glucose of a child, elderly parent, or spouse when the diabetes patient is at home or stationary. “Dexcom Share represents a significant advance in...
By  Brian Dolan 09:07 am September 24, 2014
MobiHealthNews has been tracking FDA clearances for smartphone-connected medical devices and standalone apps for many years. So far 2014 has had its fair share -- about two dozen digital health-related FDA clearances have been secured this year. Here's a roundup: New York City-based Kinsa Health received FDA 510(k) clearance for its Kinsa smart thermometer, which can be used, orally, under-arm,...
By  Jonah Comstock 11:48 am September 10, 2014
Yet another clinically-focused, activity tracking wearable has now been cleared by the FDA, this one aimed specifically at the monitoring and treatment of Parkinson's disease. The Personal KinetiGraph, from Melbourne, Australia-based Global Kinetics Corporation, "offers comprehensive, automated reporting of a Parkinson’s disease patient’s movements so that neurologists and other physicians can...
By  Aditi Pai 08:05 am August 13, 2014
Severna Park, Maryland-based mobile sleep apnea-focused company Appian Medical has raised $580,000 from angel investors to conduct validation studies and apply for FDA 510(k) clearance for its app. Appian CEO Michael Thomas told MobiHealthNews they are also starting talks with investors to raise their series A funding round. Thomas was formerly the CEO of asthma monitoring company iSonea. Appian...
By  Jonah Comstock 10:26 am July 16, 2014
Australian company dorsaVi has received FDA clearance for its ViMove sensor system. The sensor tracks movement as well as muscle activation, and is intended to be used in a clinical setting or with athletes in training. Despite the preponderance of consumer fitness trackers, FDA-cleared devices for tracking movement in the clinical sphere are just starting to emerge, partly because of the...
By  Jonah Comstock 08:38 am July 9, 2014
Washington, DC-based modus health, a spin-off of a prosthesis company called Orthocare Innovations, has launched with the goal of creating a wearable activity tracker for clinical use. The technology is building on a research device called StepWatch that Orthocare has been using for some time. "It’s sort of a wearable [that was created] before wearables were cool and it is a validated wearable...
By  Jonah Comstock 05:00 am July 3, 2014
Waltham, Massachusetts-based EarlySense, which makes a passive and contactless bedside monitor that continuously measures respiration rate, heart rate and motion, has received a new FDA clearance for a sensor designed to work with not a bed, but a chair. "Medical institutions have often expressed the need for automatic sensing in chairs," Avner Halperin, CEO of EarlySense, said in a statement. "...
By  Jonah Comstock 11:15 am May 20, 2014
Gauss's Triton Fluid Management system.   Back at the beginning of May, we reported on several mobile health FDA clearances from the previous month. But the FDA has been even busier than that, clearing at least three other big name mobile products in April, and a few more already in May. First off, this month a couple of different iPad apps received FDA clearance. At the American Telemedicine...
By  Jonah Comstock 08:38 am May 6, 2014
Propeller Health, formerly Asthmapolis, has received FDA clearance for a platform that includes a new smart inhaler and is geared for patients with either asthma or COPD. "Our goal is to minimize or eliminate exacerbations – that drives everything we do. Key to that, particularly as we move deeper into COPD, is optimizing both the patient and provider experience on Propeller," David Van Sickle,...
By  Aditi Pai 06:41 am March 20, 2014
Remote patient monitoring company HealthInterlink received FDA 510(k) class II clearance for Beacon 2.0, a mobile-centric software system that integrates data from various home health devices. Beacon was previously cleared as a class I medical device (MDDS). HealthInterlink plans to begin commercialization of the device in the US immediately. Beacon 2.0 works on tablets, smartphones and via...