FDA

FDA Sought New PreCert Participants, Cleared New Digital Health Products and More During Q2 2019

2019-07-22T23:38:45-04:00

MobiHealth News | July 19, 2019 The agency also warned consumers of unregulated diabetes products and outlined plans for AI device regulation. This quarter was another busy one for the FDA as it continued to reevaluate its approach to digital health amidst a changing of the guard from Dr. Scott Gottlieb [...]

FDA Sought New PreCert Participants, Cleared New Digital Health Products and More During Q2 20192019-07-22T23:38:45-04:00

FDA, Yale, Mayo Clinic Join Forces to Study Cardiac mHealth Data

2019-07-23T00:12:13-04:00

By Eric Wicklund, mHealth Intelligence | July 17, 2019 The FDA is joining Yale University and the Mayo Clinic in a project aimed at studying the value of mHealth data gathered in a remote patient monitoring platform for people with heart failure. The US Food and Drug Administration is partnering [...]

FDA, Yale, Mayo Clinic Join Forces to Study Cardiac mHealth Data2019-07-23T00:12:13-04:00

5 Medical Wearables Cleared by the FDA in 2019

2019-07-08T04:20:37-04:00

By Andrea Park, Becker's Hospital Review | July 2, 2019 Here are five wearable devices that have received FDA clearance or approval for medical use in the first half of 2019: 1. The IB-Stim is a prescription-only, battery-powered electrical nerve stimulator worn behind the ear that emits low-frequency electrical pulses [...]

5 Medical Wearables Cleared by the FDA in 20192019-07-08T04:20:37-04:00

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