Food and Drug Administration (FDA)

FDA building sign

Credit: FDA

By Laura Lovett 01:55 pm September 14, 2018
Though not without critics, the FDA has advanced regulatory processes for apps, medical devices, genomics and clinical decision support.
FDA's Pre-Certtification draft

Credit: FDA.gov

By Jonah Comstock 09:27 am June 25, 2018
The new guidance suggests that new KPI standards in 12 categories to allow companies to test regardless of whether they already have a device on the market.
By Bernie Monegain 12:10 pm June 05, 2018
HeartMate3 recalled because of unintended disconnection between power source and controller.
HIMSS weighs in on FDA software pre-cert program
By Mike Miliard 03:55 pm June 01, 2018
As the agency considers a lighter touch for regulating iterative versions of software-as-a-medical device, it should also stay focused on patient-centeredness, cybersecurity and more, HIMSS says.
FDA AI approval for hospitals

Credit: FDA.gov

By Mike Miliard 03:27 pm May 31, 2018
With more machine learning tools expected to get the go-ahead soon, health systems should be partnering with vendors to supply data for better algorithms.
Chris Economos, VP of Business Development at PhysIQ, speaking at the May 24 Startup Day event in Chicago.

Chris Economos, VP of Business Development at PhysIQ, making a presentation at the May 24 Startup Day event in Chicago.

By John Sharp 10:22 am May 31, 2018
Startups would be smart to align with government initiatives such as interoperability, opioid crisis, AI and price transparency.
FDA launches innovation challenge to help stem opioid crisis

Credit: GAO.gov

By Bernie Monegain 01:23 pm May 30, 2018
The contest aims to offer unique approaches to detecting, treating and preventing addiction, Food and Drug Administration officials said.
FDA EHR

Credit: GAO.gov

By Jessica Davis 01:56 pm May 04, 2018
The agency is hoping to build a database, including information from Veterans Affairs, to track adverse drug reactions through data mining and visualization.
FDA chief sees big things for AI in healthcare

Scott Gottlieb, MD, speaking at AcademyHealth 2018 event on April 26. Credit: Twitter

By Mike Miliard 08:51 am April 30, 2018
Scott Gottlieb, MD, is bullish on the opportunities artificial intelligence could bring to EHRs, decision support and more.
FDA medical device cybersecurity
By Jessica Davis 04:23 pm April 18, 2018
The agency released a five-point plan outlining regulatory changes to bolster medical device safety, including requiring manufacturers ensure devices can be updated and patched.

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