The Latest

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  The PFA race is heating up. Here’s where the market stands after J&J’s approval.

  Boston Scientific, Medtronic and J&J are moving quickly to secure their place in the fast-growing pulsed field ablation space as new devices and heart imaging technology hit the market.

  Medical Devices

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  Boston Scientific’s Watchman could be new option for patients post ablation: study

  The trial compared the stroke prevention device for left atrial appendage closure to blood thinners in people who underwent cardiac ablation for AFib.

  Clinical Trials

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  FDA warns providers on Getinge devices tied to 17 serious injuries

  Getinge recalled endoscopic vessel harvesting devices after receiving 18 complaints in four months. The FDA added the devices to its shortages list following the recall.

  Medical Devices

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  Health systems band together to test and publicly rank top AI models

  Mass General Brigham, Emory and other providers will assess different AI models from companies like Google, Microsoft and Amazon.

  AI

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  Boston Scientific closes $3.7B Axonics deal after lengthy review

  Boston Scientific announced the acquisition in January, but the review dragged on after the Federal Trade Commission requested more information.

  Medical Devices

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  Thermo Fisher eliminating 160 jobs, closing Massachusetts facility

  A facility in Lexington will close, and smaller numbers of people will be laid off at plants in Cambridge and Plainville.

  Medical Devices

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  Trump nominates RFK Jr. to lead HHS

  The nomination of a prominent vaccine skeptic to the head of the nation’s largest healthcare program is expected to alarm some public health experts.

  Medical Devices

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  Haemonetics to close California facility, lay off 75 people

  Over the past year, Haemonetics has reshaped its product portfolio through restructuring and M&A, adding devices used in cardiology procedures.

  Medical Devices

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  FDA breakthrough device decisions rebound after recent declines

  The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the downward trend seen as the COVID-19 pandemic eased.

  Medical Devices

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  GE Healthcare’s head-only MRI scanner cleared by the FDA

  The system is designed to shorten scan times, which may be better for people who struggle to stay still or have claustrophobia, and to detect more subtle abnormalities.

  Medical Devices

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  23andMe to lay off more than 200 employees amid business struggles

  The genetic testing firm will also close its therapeutics arm. CEO Anne Wojcicki said the cuts are necessary to “focus on the long-term success of our core consumer business.”

  Earnings

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  Dean Kamen, insulin pump pioneer, wants to shake up diabetes tech

  Kamen and Sequel Medtech CEO Alan Lotvin say they are offering greater precision in insulin delivery with new pump technology in the Twiist device.

  Medical Devices

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  Livanova hits sleep apnea trial goals, plans FDA filing

  Leerink analysts said the results were largely in line with outcomes in a trial of Inspire Medical’s rival device but cautioned that Livanova may have a hard time breaking into the sleep apnea market.

  Clinical Trials

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  J&J’s Ottava surgical robot to begin clinical trial after FDA nod

  With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging Intuitive Surgical’s da Vinci system.

  Clinical Trials

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  Boston Scientific resumes PFA trial in new patient group after pausing enrollment

  Boston Scientific expects to complete enrollment in the coming months in the study comparing pulsed field ablation to anti-arrhythmic drugs in patients with persistent AFib, a spokesperson said.

  Clinical Trials

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  GE Healthcare inks AI mammography pact with Radnet

  The alliance positions GE Healthcare to distribute Radnet software designed to help mammography centers view images, prioritize cases and support other steps in the workflow.

  AI

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  Advamed CEO congratulates Trump, stresses need for public policy support

  Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the agency’s contentious LDT final rule is challenged in court.

  Legal

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  Baxter to restart second IV fluid production line at hurricane-damaged site

  CFO Joel Grade told investors Friday that Baxter expects an approximately $200 million hit to sales in the fourth quarter from Hurricane Helene's disruption.

  FDA

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  How the healthcare industry is reacting to a second Trump term

  Donald Trump’s first term as president was characterized by significant turbulence for government healthcare programs. Here’s how some of the most influential industry groups responded to the Republican’s reelection.

  Medical Devices

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  Tandem, Insulet tout Type 2 expectations as tech attracts new users

  Insulet saw strong insulin pump adoption among new users with Type 2 diabetes following its recent FDA clearance, while Tandem plans to file a Type 2 submission by year’s end.

  Digital Health

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  Exact Sciences’ forecast cut shocks analysts

  The lowered sales forecast, which analysts called a “shocking guidance update,” contributed to a 23% drop in the cancer screening company’s stock on Wednesday.

  Earnings

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  J&J wins FDA approval for Varipulse PFA system

  J&J is the third medtech company to gain U.S. approval for pulsed field ablation, a new atrial fibrillation treatment seeing rapid adoption.

  FDA