Recor Medical ex-CEO Lara Barghout joins Medtronic

The Latest

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  OIG urges crackdown on equipment suppliers in Medicare Advantage

  The agency says the CMS and MA organizations aren’t doing enough to screen durable medical equipment providers, especially out-of-network companies that aren’t enrolled in Medicare.

  Medical Devices

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  Sponsored by IQVIA MedTech

  Human factors isn’t a checkbox: What FDA’s eSTAR requirements mean for MedTech submissions

  FDA’s eSTAR framework raises the bar for documenting human factors and use-related risk.

  FDA

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  Zimmer proposes to cut 580 jobs in Switzerland

  Reducing headcount at the Swiss site is part of an ongoing effort to simplify the company’s manufacturing footprint and supply chain.

  Medical Devices

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  Medtronic begins final steps to separate MiniMed

  The separation will allow Medtronic to focus on its cardiovascular, neuroscience and surgical portfolios, CEO Geoff Martha said.

  M&A

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  CMS expands TAVR Medicare coverage to asymptomatic patients

  The Centers for Medicare and Medicaid Services’ policy update extends Medicare coverage to severe aortic stenosis patients without symptoms, a change that analysts said will especially benefit Edwards Lifesciences.

  Cardiac

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  Boston Scientific fully restores operations after cyberattack

  CEO Mike Mahoney gave more details at a Thursday investor conference, saying the company likely lost orders while its plants and distribution centers were shut down.

  Cybersecurity

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  ARPA-H to award $62.7M for AI in cardiovascular care

  Companies including Tempus AI and Updoc are tasked with building an agentic AI system for managing heart failure.

  AI

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  STAAR Surgical hires former CEO to lead commercial team

  David Bailey has rejoined STAAR after participating in the successful campaign to block Alcon’s takeover of the company.

  Medical Devices

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  Axogen to buy BioCircuit Technologies for $200M

  Analysts called the acquisition a good fit for Axogen but said the company’s plans to finance the deal with a public stock offering could be a point of contention for investors.

  M&A

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  Stryker stock falls on slower peripheral vascular, hip sales

  CFO Preston Wells said at a healthcare conference that the company is still working through supply issues in its peripheral vascular business and had fewer hip sales than expected so far this quarter.

  Earnings

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  Deep Dive

  4 questions about the FDA’s approach to generative AI

  The medtech industry is awaiting FDA guidance on generative AI. The agency has sought feedback in advisory meetings and a discussion paper as the technology becomes more prevalent.

  FDA

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  Zimmer restructures Americas leadership team

  The company promoted three executives and eliminated a fourth position as part of changes intended to support its ongoing commercial transformation.

  Medical Devices

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  Labcorp acquires MLM Medical Labs in global expansion

  Buying MLM gives Labcorp a wholly owned laboratory network that spans North America, Europe, Asia and Africa.

  M&A

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  5 takeaways from Oura’s IPO filing

  The wearables firm’s sales are growing, and it is adding more paid members, but questions loom about whether the company will need to approach future features as a medical device.

  Digital Health

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  Boston Scientific unlikely to meet guidance due to cyberattack

  Despite making progress restoring global operations, the device maker said in a securities filing that it is unlikely to meet third-quarter and full-year sales and earnings forecasts.

  Cybersecurity

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  Abbott wins FDA approval for dual-energy ablation catheter

  CEO Robert Ford has said the atrial fibrillation treatment, along with the company's Volt PFA device, is expected to help Abbott regain market share in electrophysiology.

  Cardiac

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  Elucid raises $55M to commercialize cardiovascular imaging platform

  Elucid, which gained a large medtech company as an investor, plans to grow industry partnerships as it looks to expand its AI-powered imaging platform.

  Cardiac

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  Boston Scientific recall of spinal cord stimulator leads tied to more than 1,000 injuries

  A problem with the leads could cause inadequate stimulation, Boston Scientific said. In the worst case, leads may need to be removed or replaced.

  Recalls

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  Boston Scientific begins to restore shipping after cyberattack

  The company is working through a backlog after the cyberattack hampered manufacturing, order processing and shipping.

  Cybersecurity

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  Vara receives CE mark for first autonomous breast cancer screening

  The AI-enabled device can report screenings it determines are normal without radiologist review.

  AI

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  Abbott ablation device effective at 1 year in complex cases

  Abbott said it will use the study results to secure FDA approval for the TactiFlex Duo catheter that offers both PFA and RF energy for tailoring treatment of atrial fibrillation.

  Cardiac

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  NovoCure says cyberattack caused patient data exposure

  The cancer treatment company said internal data from more than 1,400 patient records were exposed in a cyberattack detected in mid-August.

  Cybersecurity

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  DaVita agrees to pay $15M to settle claims from data breach

  The dialysis provider has opted to settle a proposed class action lawsuit stemming from a data breach last year that impacted 2.7 million people.

  Cybersecurity

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  Medtronic invests $700M in Cornerstone Robotics

  Medtronic will gain rights to distribute the Hong Kong-based company’s Sentire surgical robot in certain markets outside the U.S. alongside its own Hugo system.

  Medical Devices

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  Stryker to add rotator cuff repair tech with ZuriMED buy

  Rotator cuff augmentation is one of the fastest-growing areas in sports medicine, according to Stryker.

  M&A

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  Enovis inks eCential takeover to develop surgical ortho robots

  The orthopedics specialist aims to launch a knee robot in late 2028, followed by a shoulder robot in 2029.

  M&A

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