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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Chembio, Haemonetics, Histosonics, Pixcell Medical, Quidel.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Dcao Solutions, Gentex, Icecure Medical, Masimo, Premier, Retispec, Senseonics Holdings, Spineology, Terumo, Vaxxas, Xenocor.
TORONTO – Health Canada has approved a portable COVID-19 test kit which began as a testing regime for identifying pathogens, microbes and viruses in the European food and natural products industry. The Hyris Bcube developed by Guelph, Ontario-based Songbird Life Science Inc., in partnership with London, U.K.’s Hyris Ltd., is described as a portable DNA-based “laboratory in a box” for coronavirus testing in large urban spaces as well as more remote, indigenous communities in Canada’s north.
The COVID-19 pandemic has done little to encourage bipartisan comity in Washington, and the Oct. 2 hearing of the House Select Subcommittee on the Coronavirus Crisis reflected that partisan tension. Secretary of Health and Human Services Alex Azar noted, however, that the department is doing its best to cooperate with oversight of the vaccine program by the Government Accountability Office (GAO), but that the nearly three dozen GAO requests for oversight have come at a difficult time.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dascena, Labcorp, OralDNA Labs.