The company’s “Investor Day” brought about several headlines, including new clinical trials ahead and a rallying cry from CEO Geoff Martha.
Other news that garnered some attention came in the form of a new ultrasound system from another big player in medtech, some legal news regarding an ongoing patent spat and, of course, more news regarding COVID-19 testing.
Want to hear more about the week’s top news? Assistant editor Sean Whooley fills in for executive editor Chris Newmarker to discuss the week’s “Newmarker’s Newsmakers” with Tom Salemi during our DeviceTalks Weekly podcast.
Without further ado, here’s this week’s MassDevice Top Five:
5. Abbott wins EUA for COVID-19 IgM antibody test
Abbott (NYSE:ABT) received FDA emergency use authorization (EUA) for its IgM antibody serology test for COVID-19. The AdviseDx SARS-CoV-2 IgM lab-based serology test runs on the Architect and Alinity platforms to detect antibodies in response to the virus, indicating a recent or prior infection.
Similar to the IgG test developed by Abbott, the IgM test has demonstrated high reliability, including 99.56% specificity and 95% sensitivity for patients tested 15 days after symptom onset. Abbott Park, Ill.-based Abbott’s latest test is the company’s seventh to receive EUA. Read the full story.
4. U.S. Supreme Court to hear challenge in Arthrex-S+N patent spat
The U.S. Supreme Court said that it will review a 2019 appeals court ruling in a patent spat between Arthrex and Smith+Nephew (NYSE:SNN), in which the appeals court judges found that Patent Trial and Appeal Board judges are unconstitutionally appointed. In appealing the decision to the U.S. Supreme Court, Arthrex described the ruling as “no remedy at all,” according to a recent Bloomberg report. Arthrex, Smith+Nephew and the U.S. government each requested a Supreme Court review.
The 2019 ruling by the U.S. Federal Circuit Court of Appeals in Washington, D.C. could cause the rehearing of more than 100 technology disputes by the board, according to Reuters. Read the full story.
3. FDA clears GE Healthcare’s AI-powered cardiovascular ultrasound system
GE Healthcare (NYSE:GE) announced that it received FDA 510(k) clearance for its Ultra Edition package on Vivid cardiovascular ultrasound systems. The Ultra Edition package on Vivid cardiovascular ultrasound systems includes new features that are based on artificial intelligence (AI) designed to enable clinicians to acquire faster, more repeatable exams on a consistent basis. Read the full story.
2. Medtronic launches head-to-head TAVR study against Edwards
Medtronic (NYSE:MDT) announced it will begin a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS), primarily in women. The postmarket SMART trial will compare valve safety and performance of the self-expanding Medtronic Evolut PRO and PRO+TAVR Systems against Edwards Lifesciences’ (NYSE:EW) balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves. Read the full story.
1. Medtronic CEO Geoff Martha: ‘Time to be bold and add grit’
Medtronic (NYSE:MDT) CEO Geoff Martha said at the company’s “Investor Day” that it must “bold and add grit” as it enters a period of major restructuring — with expected annual savings of $450 million to $475 million by 2023. Martha had recently said he’s only looking forward to whatever the post-pandemic, new normal brings as he puts the medtech giant on the offensive, touting plans for a “new Medtronic” that is more nimble and competitive. Read the full story.