FDA

By Jonah Comstock February 9, 2016
Withings has added a new paid software feature to its Health Mate app, an algorithm called Hy-Result that will help patients analyze the blood pressure data they collect from Withings devices. “With cardiovascular disease being the leading global cause of death, accounting for 17.3 million deaths per year, everyday monitoring blood pressure becomes an increasingly important part of anyone’s...
By Jonah Comstock January 13, 2016
Neurometrix has received FDA clearance for a new smartphone-controlled version of Quell, its wearable for pain relief, the company announced last week. Like its predecessor, the device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids. It's worn around the calf. “This 510(k) further advances Quell technology by allowing the...
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 November 4, 2015
Exco InTouch's mobile clinical trial software. The FDA wants to know more about mobile-enabled clinical trials for investigational drugs. According to a recent post on the Federal Register by Associate Commissioner for Policy Leslie Kux, the FDA is soliciting comments "from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct...
By Aditi Pai October 22, 2015
Almost two years after the FDA first told 23andMe to halt sales on its mail-order direct-to-consumer genetic testing service for disease risks, the company has relaunched a version of its new Personal Genome Service (PGS), which now meets FDA standards. “We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," 23andMe CEO Anne Wojcicki...
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...
By MHN Staff September 10, 2015
by Bradley Merrill Thompson Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea. Indeed, let’s say there’s nothing else like it. To bring the first tongue depressor to market, it’s quite likely I would have to spend years conducting clinical trials, to be followed up by perhaps a year of FDA review. For a tongue depressor. Why...
By Jonah Comstock August 17, 2015
Israeli medical device company Integrity Applications has begun the process with the FDA to bring its noninvasive glucose monitoring device, GlucoTrack, to the United States. GlucoTrack allows users to monitor their blood glucose level without drawing blood. The user wears a clip on his or her ear, and GlucoTrack uses a combination of sensors to determine blood glucose level, then sends the data...
By Aditi Pai August 4, 2015
Naperville, Illinois-based PhysIQ has received an FDA 510(k) clearance for its personalized physiology analytics system. The offering is categorized as a Class II device for patient monitoring under the product code: automated calculation of a summary index based on several individual measured vital sign inputs. PhysIQ's offering is an early warning detection platform that analyzes a user's...

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