The Latest

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  Baxter closes dialysis solutions facility due to Hurricane Helene damage

  More than 2,500 people work at the facility, which is Baxter’s largest manufacturing site. The company is still working to fully assess the damage.

  Updated Sept. 30, 2024

  Medical Devices

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  Establishment Labs wins FDA approval for Motiva breast implants

  Motiva is the first new breast implant to receive premarket approval since 2013, according to Establishment Labs, and enters a market reshaped by safety issues linked to other products.

  Medical Devices

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  What’s next at Masimo after CEO Kiani’s exit?

  Investors are waiting to learn the next steps for the patient monitoring company after a hard-fought proxy battle, including how a separation of its consumer business could play out.

  Medical Devices

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  Mendaera raises $73M to develop handheld robotics platform

  Fred Moll, founder of surgical robotics firms Intuitive Surgical and Auris Health, participated in in the financing round, along with previous Auris investors.

  Medical Devices

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  Lawmakers call for investigation of former FDA device director

  The letter to the health department watchdog follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.

  Medical Devices

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  Remote patient monitoring in Medicare needs more oversight: OIG

  Regulators say Medicare needs more data and oversight to avoid fraud and misuse. Digital health advocates argue the service is still crucial for managing chronic conditions.

  Digital Health

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  Congress again delays steep cuts in Medicare lab payments

  The American Clinical Laboratory Association welcomed the reprieve but said long-term reform of the Medicare payment system is still needed.

  Diagnostics

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  Medtech’s top executive moves in 2024

  Recent executive changes include former Medtronic CFO Karen Parkhill leaving for HP and Masimo CEO Joe Kiani resigning. Check out MedTech Dive’s roundup of leadership movement in 2024.

  Updated Sept. 26, 2024

  Medical Devices

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  FDA proposes reclassifying hepatitis B assays

  The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

  Medical Devices

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  Masimo CEO, founder Kiani resigns

  Michelle Brennan was named acting CEO of the patient monitoring company following Joe Kiani’s defeat in a proxy battle with an activist investor.

  Medical Devices

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  Medtronic, Siemens Healthineers partner on spine surgery

  Siemens Healthineers will integrate its robotic X-ray imaging system with Medtronic’s spine surgery suite.

  Digital Health

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  Roche launches test that detects 12 respiratory viruses

  Roche’s TAGS technology allows tests to simultaneously detect multiple respiratory viruses, including influenza A and B, RSV and the COVID-19 virus.

  Diagnostics

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  FDA names new head of medical device evaluation and quality

  Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

  Medical Devices

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  Recalled heart devices had limited clinical testing, study finds

  Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.

  Medical Devices

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  Route 92 Medical raises $50M to fund global sales of stroke devices

  The latest investment extends an earlier funding round, bringing the total raised to $82 million. Novo Holdings, the controlling shareholder of Novo Nordisk, joined returning investors.

  Medical Devices

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  Deep Dive

  4 steps to minimize the threat of legacy medical devices

  Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.

  Medical Devices

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  Stryker adds devices to remove brain tumors, clots with Nico buy

  Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue.

  Medical Devices

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  FDA posts draft guidance on biocompatibility testing of devices

  To promote consistency and reliability in premarket submissions, the FDA shared approaches for device biocompatibility analysis.

  Medical Devices

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  Masimo investor claims proxy war win as CEO Kiani fails to retain board seat

  Politan Capital Management said its candidates captured two board seats in Thursday’s shareholder vote, citing a preliminary analysis.

  Medical Devices