The Latest

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  Hologic to lay off 86 people in closure of Connecticut facility

  The company committed to closing the facility, which makes breast health products, in late 2021 and gave most employees the option to relocate to other sites.

  Medical Devices

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  The Medtech Conference

  That’s a wrap: 5 takeaways from The Medtech Conference

  The conference — Advamed’s largest — featured an appearance by the device center’s new acting director and sessions on AI, clinical trial diversity and the FDA’s contentious LDT rule.

  Clinical Trials

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  Boston Scientific, Edwards and Dexcom usher in second week of earnings

  Johnson & Johnson, Abbott and Intuitive Surgical made a mixed start to earnings season last week.

  Medical Devices

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  GE Healthcare opens AI Innovation Lab to grow new projects

  The AI Innovation Lab is designed to accelerate early concept artificial intelligence projects including tools to predict the recurrence of cancer and automate image interpretation.

  Digital Health

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  Deep Dive

  5 steps to navigate the FDA’s new lab developed test rule

  Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.

  FDA

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  Boston Scientific wins FDA approval for Farapulse cardiac mapping

  Stifel analyst Rick Wise said Boston Scientific can now offer “one-stop-shopping” with a pulsed field ablation catheter and integrated mapping system to treat atrial fibrillation.

  FDA

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  Boston Scientific blood-blocking agent tied to additional 2 deaths, 8 injuries

  After a February recall, Boston Scientific has warned physicians about new safety risks for Obsidio Embolic, which is now connected to a total of 15 injuries and four deaths.

  Medical Devices

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  Intuitive readies da Vinci 5 for broader launch after placing 110 robots in Q3

  BTIG analysts wrote that installations of Intuitive’s new robotic surgery system are “well ahead of lofty” expectations.

  Medical Devices

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  The Medtech Conference

  Tarver, acting CDRH director, sets tone for future of the device center

  Former CDRH leader Jeff Shuren told an audience at The Medtech Conference that Michelle Tarver “will make an excellent center director, and quite frankly, the best is yet to come.”

  Medical Devices

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  Novocure wins FDA approval for electric field device in lung cancer

  Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.

  Medical Devices

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  Medtech Europe calls for urgent reform of MDR and IVDR

  The trade group’s intervention follows news that the new commissioner for Health and Animal Welfare will assess the need for legislative changes.

  Medical Devices

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  FDA prioritizes guidance on lab developed tests in 2025 plan

  The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.

  Medical Devices

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  The Medtech Conference

  Legacy medical devices keep regulators up at night

  The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem regulators and industry need to work on together.

  Medical Devices

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  CMR Surgical gets FDA de novo nod for Versius robot

  After expanding in global markets, the U.K.-based company will challenge Intuitive Surgical in the U.S., starting with gallbladder removal procedures.

  Medical Devices

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  FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs

  Cue Health began the recall of nearly 250,000 COVID-19 test kits in May, shortly after the FDA advised people at home and healthcare professionals not to use the products.

  COVID-19

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  The Medtech Conference

  FDA, Health Canada give sneak peek into future AI regs

  Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.

  Digital Health

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  Abbott CEO sees ‘mass market potential’ for CGMs

  Robert Ford’s comments come as new CGMs and insulin pumps continue to roll out in the diabetes tech space, including over-the-counter glucose sensors.

  Medical Devices

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  Health officials outline industry role in AI oversight in JAMA article

  FDA Commissioner Robert Califf and two colleagues warned that the “scale of effort” needed to repeatedly evaluate AI models “could be beyond any current regulatory scheme.”

  FDA

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  J&J’s recent medtech buys help to prop up devices unit

  Johnson & Johnson’s medtech acquisitions over the past year have fueled growth for its cardiovascular group, offsetting challenges in businesses like orthopedics and surgery.

  Medical Devices

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  FTC increases premerger reporting requirements over provider objections

  Companies will be required to disclose more information about minority investors and past M&A activity. Provider groups said the new requirements would be burdensome for hospitals.

  Legal

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  Hologic to buy Gynesonics for $350M to acquire fibroid system

  Gynesonics’ transcervical system uses ultrasound guidance and radiofrequency energy to ablate fibroids without the need for an incision.

  Medical Devices

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  Medtronic to evaluate Affera in ventricular tachycardia

  The FDA approved an early feasibility study of Medtronic’s Affera mapping and ablation system and Sphere-9 catheter in patients with ventricular tachycardia, an abnormal heart rhythm.

  Medical Devices

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  The Medtech Conference

  4 trends to watch at Advamed’s The Medtech Conference

  As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential election loom over the industry.

  Medical Devices

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  J&J, Abbott and Intuitive kick off latest medtech earnings season

  From pulsed field ablation to diabetes tech and surgical robots, the updates will provide an early look at how key medtech markets performed last quarter.

  Medical Devices

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  Digital health deal count declines in Q3, but check sizes stabilize: Rock Health

  Startups notched 110 deals in the third quarter, compared with 133 in the second quarter. But average deal size held steady, suggesting investors are making “fewer, more focused bets,” according to the consultancy firm.

  Digital Health

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