FDA 510(k)

By Jonah Comstock November 15, 2018
On its third quarter earnings call last week, Dexcom recapped a busy Q3 — of note, one that included the acquisition of TypeZero Technologies for $11.3 million in August as well as two new FDA clearances in October and November. One of these clearances was for a new mobile app interface for the Dexcom G6 while the other was the Dexcom Pro Q CGM, a new disposable glucose monitoring device intended...
By Jonah Comstock November 1, 2018
Just a short while after securing a CE Mark for its second generation device, Abbott has been granted FDA clearance for FreeStyle LibreLink, a companion mobile app for its 10 to 14-day CGM. The launch adds a long-awaited feature for US users that’s been available for some time in Europe: users will be able to scan their sensors with an app on their smartphone — and see their latest reading —...
By Dave Muoio October 10, 2018
Last week FibriCheck announced that it received FDA 510(k) clearance for its app, which uses a smartphone’s camera and artificial intelligence to monitor for heart rhythm disorders. With this, the Belgian company expects to bring its product to the US market sometime in 2019. To identify atrial fibrillation, FibriCheck monitors the user's heart rhythm via photoplethysmography. From there, an...
By Jonah Comstock July 25, 2018
Correction: Thanks to an eagle-eyed reader, this story has been updated to remove the claim that Dip.io is the first FDA-cleared smartphone urine test. We've reached out to Healthy.io for comment on this development and we'll update when we hear more. Tel-Aviv, Israel-based Healthy.io has secured FDA 510(k) clearance for Dip.io, a home-based urinalysis kit that turns a smartphone into a clinical-...
By Jonah Comstock June 22, 2018
At long last, Eversense, the implantable continuous glucose monitoring system from Senseonics, has received FDA clearance to be marketed in the United States. “The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “These technologies allow patients to gain better control over their...
By Jonah Comstock May 16, 2018
Cambridge, Massachusetts-based sensor maker MC10, known for its flexible and stretchable electronics, has received its first FDA 510(k) clearance for the BioStamp nPoint system. BioStamp nPoint is a more advanced version of the company's non-FDA cleared BioStampRC. "BiostampRC was primarily developed as an investigational tool, primarily used by academia, as well as by pharmaceutical companies,...
By Jonah Comstock February 9, 2018
Smart thermometer and connected health company Kinsa has launched a new wireless version of its device, called Kinsa QuickCare, after securing FDA clearance last month. “Partly, this is our response to the fact that the headphone jack is gone,” Kinsa CEO Inder Singh told Babyforyou.net.ua. “The first version of our stick was corded and connected to the headphone jack, so our answer to that is a...
By Jonah Comstock February 5, 2018
Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone. The clearance is as a prescription, not an over-the-counter device, which means users will have to secure a prescription...
By Babyforyou.net.ua December 21, 2017
In 2017, Babyforyou.net.ua covered 51 devices that received clearance from the FDA. Along with a handful of diagnostic devices, disease management platforms, and novel monitors, this year boasted a few surprises from the agency, such as the approval of a direct-to-consumer genetic tests for disease risk and a purely digital intervention. The year also hosted its fair share of regulatory news and...
By Jonah Comstock November 16, 2017
Medical device software company Voluntis has received an updated FDA clearance (as well as an updated CE mark) for its Insulia app, a "digital companion" app for people with Type 2 diabetes. Insulia offers realtime basal insulin dose coaching, and the new clearance makes the app usable with two additional brands of insulin: Basaglar and Tresiba. The app had already worked for users of Lantus,...
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