FDA

FDA ‘White Hat’ Hacking Tools May Combat Medical Misinformation

2019-06-19T01:09:07-04:00

By Susan Kelly, Med Tech DIVE | June 17, 2019 Dive Brief: Former FDA Commissioner Robert Califf has suggested cybersecurity techniques the agency is incorporating into its program to protect internet-connected medical devices from hackers also could be used to fight the dissemination of medical misinformation that poses a rapidly [...]

FDA ‘White Hat’ Hacking Tools May Combat Medical Misinformation2019-06-19T01:09:07-04:00

Merck and Walmart Will Track Prescription Drugs On IBM Blockchain In FDA Pilot

2019-06-19T04:06:07-04:00

By Rachel Wolfson, contributor, Forbes | June 13, 2019 The United States Food and Drug Administration (USFDA) announced today that IBM, KPMG, Merck and Walmart will be included in a pilot project in support of the U.S. Drug Supply Chain Security Act (DSCSA). Together, these companies will address the requirements [...]

Merck and Walmart Will Track Prescription Drugs On IBM Blockchain In FDA Pilot2019-06-19T04:06:07-04:00

FDA Approvals For Smart Algorithms In Medicine In One Giant Infographic

2019-06-07T11:35:41-04:00

The Medical Futurist | June 6, 2019 Mental health algorithms mimicking empathy? A.I. outsmarting human doctors? Simple big data analytical software presented with clever marketing tactics? It’s difficult to assess the actual state of play when it comes to artificial intelligence in healthcare. Moreover, there’s no database that contains all [...]

FDA Approvals For Smart Algorithms In Medicine In One Giant Infographic2019-06-07T11:35:41-04:00

Roche, J&J Regulatory Leads Weigh In On Pre-Cert’s Progress, Challenges of Regulating Digital Health

2019-06-09T19:06:04-04:00

By Dave Muoio, MobiHealth News | June 4, 2019 At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address. Since it was first announced, [...]

Roche, J&J Regulatory Leads Weigh In On Pre-Cert’s Progress, Challenges of Regulating Digital Health2019-06-09T19:06:04-04:00

FDA Soliciting New Volunteers to Test Drive Its Experimental Pre-Cert Program

2019-05-26T18:02:38-04:00

By Dave Muoio, MobiHealth News | May 22, 2019 Companies planning an upcoming De Novo or 510(k) submission for their software medical device are eligible, but participation will not yield precertification. The FDA has put out a call for new companies to test drive the current framework of its Digital [...]

FDA Soliciting New Volunteers to Test Drive Its Experimental Pre-Cert Program2019-05-26T18:02:38-04:00

FDA Cracks Down on DIY mHealth Platforms for Diabetes Care Management

2019-05-21T13:21:17-04:00

By Eric Wicklund, mHealth Intelligence | May 20, 2019 The US Food and Drug Administration has issued a warning that jury-rigged, altered or unauthorized mHealth platforms for diabetes care management could cause harm, even death. The US Food and Drug Administration is cracking down on do-it-yourself mHealth devices for people [...]

FDA Cracks Down on DIY mHealth Platforms for Diabetes Care Management2019-05-21T13:21:17-04:00
Go to Top