FDA 510(k)

By Laura Lovett January 18, 2019
This morning Alphabet’s life science subsidiary Verily announced that its Verily Study Watch and its on-demand ECG feature landed a 510(k) clearance from the FDA. The watch is a prescription-only device, and was designed to record, store, transfer and display single-channel ECG rhythms. The company said the device’s ability to take on-demand, single-lead ECG can be used for individual patient...
By Dave Muoio December 21, 2018
The last few months of 2018 have been fairly active for digital health regulation, with the US FDA roughly a dozen noteworthy devices and consumer health products. But the bigger news out of the agency this quarter comes in the form of its market guidance. For instance, the very beginning of October saw the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response...

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By Dave Muoio November 27, 2018
Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern predicate devices as well as objective safety and performance criteria during regulatory submission. In the interest of promoting innovation, FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren,...
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...

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