FDA

FDA Pre-Cert panel at Connected Health Conference

(L to R) Moderator Scott Thiel, Pear Therapeutics' Dan Amor, Verily's Afia Asamoah, Tidepool's Howard Look, and Johnson & Johnson's Eduardo Sanchez (photo by Jonah Comstock)

By Jonah Comstock October 19, 2018
Attendees to the Connected Health Conference in Boston this week got a sneak peek into the workings of the FDA's much-discussed Pre-Cert program. In a panel discussion at the event, representatives from Verily, Pear Therapeutics, Tidepool, and Johnson & Johnson candidly discussed their experiences so far with the program, describing an evolving process that is collaborative and rigorous.  "...
By Dave Muoio October 16, 2018
In April of this year, the FDA released a five-point action plan to improve medical device safety that included a clear focus to reduce cybersecurity existing vulnerabilities and promote strong practices for future devices. Since then the agency hasn’t dragged its feet — earlier this month FDA Commissioner Dr. Scott Gottlieb released a lengthy statement announcing the release of a cybersecurity...

Senator Elizabeth Warren at a rally in Cambridge, Massachusetts, in September. Photo by Scott Eisen, Getty Images

By Jonah Comstock October 10, 2018
The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.), and Tina Smith (D-Minn.). The 12-page letter contains no less than 50 questions for the agency about the program, ranging from how it will derive its statutory authority to how it will pay for the program absent traditional...
code on a computer screen
By Dave Muoio October 1, 2018
FDA Commissioner Dr. Scott Gottlieb released a statement today unveiling the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook — a document co-authored with the non-profit Mitre Corporation describing how healthcare delivery organizations can best prepare their medical devices and staff for a device security breach. The agency also announced the development of its...

Ascensia's Contour Next was the top-performing meter in the study.

By Jonah Comstock September 26, 2018
What happened In a triple-blinded, multisite, independent study, researchers have found that only one third of commercially available FDA-cleared blood glucose meters in the United States could consistently perform to an accuracy standard close to, but actually more lenient than, the FDA’s. Of the 18 BCGs tested, only six were consistently accurate in each of three test sites. Five were compliant...
poll results graphic
By Jonah Comstock September 17, 2018
Last week, as part of our Focus on Innovation, HIMSS Media ran a poll about the FDA's Pre-Cert program. The program isn't new, but we thought it would be a good moment to take the public pulse on a program that has seen a variety of reactions from inside the industry. Just under 500 readers responded. In general, those opposed the program constituted a vocal minority — just 7.1 percent of...
By Jonah Comstock September 13, 2018
Yesterday, Apple dropped a bombshell on the digital health world, as it is prone to do in its highly-produced launch events. While the announcement included fall detection on the Apple Watch and some improvements to heart rate monitoring, the headline was definitely the announcement that the Apple Watch Series 4 would contain an FDA-cleared ECG sensor. While much of the reaction has been positive...
Apple Watch with ECG feature
By Jonah Comstock September 12, 2018
Well, we finally know what cardiac project Apple was talking with the FDA about two years ago. Apple Chief Operating Officer Jeff Williams announced today at Apple's special event in Cupertino that the company has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the company's Series 4 Apple Watch, due to start shipping September 21. ...
By Dave Muoio September 11, 2018
Mountain View, California-based AliveCor announced yesterday that its KardiaK Software Platform has been granted Breakthrough Device designation by the FDA. AliveCor’s software is a neural network trained to read ECG data for elevated levels of blood potassium, a condition known as hyperkalemia that affects the kidneys. Primarily diagnosed through invasive laboratory blood test, KardiaK would...
By Bradley Merrill Thompson September 7, 2018
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS. FDA’s concept of a...