The medtech industry continues to plug along as major news comes in about vaccines, the incoming presidential administration and more.
This week’s top stories include the latest on COVID-19, Joe Biden and some additional FDA clearances, plus a major royalties spat.
Want to hear more about the week’s top medtech news on MassDevice? Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” — as well as play some drum and bugle corps music — during our DeviceTalks Weekly podcast.
Without further ado, here’s this week’s MassDevice Top Five:
5. FDA authorizes at-home COVID+flu test from Quest Diagnostics
The FDA has given emergency use authorization for a COVID-19 and flu combination diagnostic from Quest Diagnostics (NYSE:DGX). Quest’s test detects and differentiates nucleic acid from the viruses through nasal swab specimens collected at home by individuals for whom home collection is deemed appropriate by a healthcare provider. Read the full story.
4. FDA says Pfizer’s COVID-19 vaccine meets success criteria
The FDA said that the COVID-19 vaccine candidate made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) meets its success criteria ahead of this week’s critical advisory meeting which could see the vaccine move toward emergency authorization.
According to the FDA, the vaccine offered protection after the first dose, while two doses — required by Pfizer about three weeks apart — were “highly effective” in preventing confirmed COVID-19 infection at least seven days after the second dose. Read the full story.
3. Biden makes picks for HHS secretary, CDC director
President-elect Joe Biden has made selections for leaders of the U.S. Dept. of Health & Human Services and the Centers for Disease Control & Prevention. Biden is unveiling his plan for his administration and for the handling of the COVID-19 pandemic, but has not yet chosen a nominee for the role of FDA commissioner. Read the full story.
2. Boston Scientific gains FDA nod for SCS
Boston Scientific (NYSE:BSX) announced that it received FDA approval for its WaveWriter Alpha spinal cord stimulator systems. The company touts the system as the only SCS portfolio that can layer paraesthesia and paraesthesia-free options simultaneously, supporting up to 32 contacts targeting specific nerves along the spinal cord. Read the full story.
1. Court confirms $112M Medtronic loss in royalties spat
An appeals court in Indiana upheld a $112 million jury award in favor of a local spine surgeon turned medical device inventor in his seven-year royalties dispute with Medtronic (NYSE:MDT). A three-judge panel let stand a $112,452,269 verdict in favor of Dr. Rick Sasso, who sued Medtronic in 2013, alleging that the world’s largest medical device maker shorted him on their royalties deal for the Vertex cervical spine system he helped develop. Read the full story.