FDA

By Dave Muoio November 14, 2018
De Novo clearance for urinary incontinence wearable. The FDA has granted De Novo clearance to Atlantic Therapeutics’ Innovo therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence. The wearable is intended for adult women as a front-line or second-line therapy, and in a multi-center randomized controlled trial recorded an 87 percent rate of...
By Dave Muoio November 8, 2018
Clinical diagnostic and workflow software maker MaxQ AI has received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. The company received notification from the FDA of its decision in late October. Results generated by the algorithm-based software are...
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 31, 2018
Yesterday afternoon the FDA announced that it would permit 23andMe to market its Personal Genome Service Pharmacogenetic Reports test. The test offers consumers information on whether they posses one of 33 variants across multiple genes that could impact their body’s ability to metabolize certain medications. The purpose of this test is to inform patients and encourage them to more thoroughly...
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...
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