Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine.

Device makers have wondered in the past whether they like the idea of the Centers for Medicare & Medicaid Services (CMS) peering over the U.S. FDA’s shoulders in premarket applications, which might be a concern as well for the Medicare program for coverage of breakthrough devices. Tamara Syrek Jensen, director of the Coverage and Analysis Group at CMS, declined to say whether her office has any influence over what would be designated as a breakthrough device by FDA, stating little more than that “we will constantly be talking with the FDA” about breakthrough devices.

An artificial intelligence machine learning model that mines electronic health record data could help physicians fight the opioid epidemic by targeting non-opioid pain treatments to patients experiencing severe pain after surgery, according to new research presented at the Anesthesiology 2020 annual meeting.

What is the future of med-tech innovation in the wake of COVID-19? That was the question addressed during the Advanced Medical Technology Association’s Virtual Medtech Conference, with members of industry providing some insight. “I think … that this is going to be in many ways a turning point,” changing the way stakeholders look at devices and the evidence supporting them, said Tom O’Brien, of Johnson & Johnson’s (J&J) Ethicon unit.

HONG KONG – Israel’s Ben-Gurion University of the Negev (BGU) has set up a company to further develop and commercialize its technology into a wearable device for predicting epilepsy-related seizures.

In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials.