FDA 510(k)

By Dave Muoio April 15, 2019
Another recent update to the FDA’s 510(k) premarket notification database suggests that AliveCor is inching closer and closer to its next volley of smartphone-connected ECG products. According to the agency, the digital health company received clearance related to its KardiaMobile platform, as well as something called the KardiaStation, on Friday. The application for the device or devices was...
By Jonah Comstock March 21, 2019
This article has been updated with a new photo and additional information from Omron. Omron has apparently finally received FDA 510(k) clearance for its Blood Pressure Monitor + EKG device, which was originally announced in January 2018 at CES. The device was created in partnership with AliveCor. This is a separate product from Omron's HeartGuide watch, which also incorporates AliveCor ECG...
By Jonah Comstock February 28, 2019
Toronto-based CardioComm, a longtime player in the handheld personal ECG space will finally make data available on consumers' smartphones with a new 510(k) clearance for its GEMS Mobile smartphone app, which works on both iOS and Android devices. The company also received clearance for a new ECG device called HeartCheck CardiBeat.  Notably, these are over the counter clearances, allowing the app...
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...

Credit: FDA.gov

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. Update 4/16/19: This story has been updated with additional clarity from Healthy.io about the difference between this clearance and previous...