FDA

FDA takes first steps toward new guidance for adaptive medical AI
By Jonah Comstock | 02:16 pm | April 03, 2019
An exploratory whitepaper dropped yesterday lays out a framework that the FDA hopes to present in a future draft guidance.
FDA clears Spry Health's remote monitoring wearable for COPD patients
By Dave Muoio | 03:31 pm | April 02, 2019
The Loop System continuously collects and analyzes health data to warn providers of potential deterioration. The company says it has already inked a deal with a major health system.
FDA regulations could create digital health opportunities for pharma
By Laura Lovett | 04:28 pm | March 28, 2019
A new report from PwC predicts that new and proposed FDA regulations could open up doors for pharmaceutical companies looking to develop digital tools. 
FDA co-sponsors horror video game to scare teens away from cigarettes
By Dave Muoio | 04:37 pm | March 21, 2019
The free game evokes inflamed organs, tar-filled pits and other jarring imagery to drive home its metaphor for smoking's side effects.
Omron gets long-awaited FDA nod for combined EKG-blood pressure monitor
By Jonah Comstock | 03:36 pm | March 21, 2019
Partner AliveCor also got a mysterious new FDA clearance.
Israel-based Theranica raises $35M in series B funding
By Dean Koh | 01:02 am | March 19, 2019
Founded in 2016, Theranica, a biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, yesterday announced the closing of its round B of financing, of $35M, led by aMoon, Israel's largest healthcare VC.
Garmin launches high-end smartwatches, FDA cracks down on tele-abortion, and more digital health briefs
By Jonah Comstock | 04:13 pm | March 13, 2019
Also: FDA cracks down on tele-abortion companies; Klara adds an investor.
Why the FDA needs to correct bad information on its website
By Bradley Merrill Thompson | 12:07 pm | March 08, 2019
Ironically, the agency that goes after companies for false and misleading claims is making them about its own policies.
FDA: Two deaths linked to malfunction of Zoll's LifeVest wearable defibrillator
By Jonah Comstock | 02:44 pm | March 07, 2019
The Pittsburgh medical device company has issued a voluntary recall and is making software, training changes in response.
Gottlieb, whose FDA made major strides in digital health, resigns as commissioner
By Jonah Comstock | 05:45 pm | March 05, 2019
According to the Washington Post, which broke the news, the commissioner is leaving to spend more time with his family.