Food and Drug Administration (FDA)
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.
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.
12:10 pm June 05, 2018
HeartMate3 recalled because of unintended disconnection between power source and controller.
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.
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.
10:22 am May 31, 2018
Startups would be smart to align with government initiatives such as interoperability, opioid crisis, AI and price transparency.
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.
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.
08:51 am April 30, 2018
Scott Gottlieb, MD, is bullish on the opportunities artificial intelligence could bring to EHRs, decision support and more.
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.