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Home » The top 5 MassDevice stories of the week — October 16, 2020

The top 5 MassDevice stories of the week — October 16, 2020

October 16, 2020 By Sean Whooley

MassDevice Top Five medtech stories weekFor the second consecutive week, medtech giant Medtronic (NYSE:MDT) managed to dominate the news on MassDevice.

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.

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Clinical Trials, Diagnostics, Genomics/Molecular Diagnostics, Health Technology, Imaging, Legal News, Replacement Heart Valves, Software / IT, Structural Heart, Ultrasound Tagged With: Abbott, arthrex, artificial intelligence, coronavirus, COVID-19, Edwards Lifesciences, GE Healthcare, Medtronic, Smith+Nephew

In case you missed it

  • Shareholder lawsuit over BD’s Alaris pumps recall moves forward
  • Dyad Medical wins FDA clearance for cardiac imaging platform Echo:Prio
  • Outset Medical wins national VA contract
  • Inspire Medical Systems appoints former Zimmer Biomet exec as VP of investor relations
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Acutus Medical ticks up on revenue beat, missed EPS in Q2 results
  • ResMed expects steady growth over the next year
  • Ambu is letting go of 200 employees
  • Medtronic has Class I recall for low-shock risk in ICDs
  • Titan Medical to start manufacturing Enos systems later this year
  • ZimVie sales down more than 11% in Q2 as it streamlines after spinoff
  • Cardinal Health’s CFO to move up to corner office
  • Levita Magnetics raises $26M for Magnetic-Assisted Robotic Surgery platform
  • Data supports use of Channel Medsystems Cerene cryotherapy
  • The 10 largest orthopedic device companies in the world
  • Nanopath raises $10M Series A for women’s health diagnostics
  • Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy

RSS From Medical Design & Outsourcing

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  • What’s next for Jennifer Fried after leaving Explorer Surgical?
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    COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers. The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies… […]
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    Confluent Medical Technologies this week announced the opening of its new addition to its Costa Rica manufacturing facility. The expansion adds 66,000 sq. ft to its large-scale manufacturing center of excellence in Alajuela, Costa Rica to expand Confluent’s capacity for nitinol component processing and complex catheter manufacturing. “Confluent has experienced consistent and strong growth in… […]
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    Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases. According to recent metrics published by FDA, the agency has issued a total of… […]
  • Lifecore Biomedical’s owner plans to go all-in on contract development and manufacturing
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  • COVID-19 immunity test developers at MIT seek diagnostic manufacturer
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  • GE Healthcare picks AI imaging startups for inaugural Edison Accelerator
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  • Boston Scientific whistleblower launches corruption investigation
    Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam. Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission. “In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam.… […]

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