The Latest

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  SS Innovations submits robotic system for FDA clearance

  After introducing its robot in multiple countries outside the U.S., including India, the company turns its focus to the world’s largest robotic surgery market.

  Medical Devices

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  HHS outlines strategy to expand AI adoption

  Although the strategy is internally focused to start, the agency said it will collaborate with the private sector and identify “priority” conditions and health issues that could be addressed with AI tools. 

  AI

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  Freenome inks deals to list stock and raise $330M

  The company plans to use the proceeds to expand its commercial and data infrastructure to support the launch of multiple blood-based cancer detection tests.

  Diagnostics

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  FDA advisory panel votes unanimously against J&J heart shunt

  Panelists focused on study data that showed the implant did not improve outcomes in heart failure patients.

  Clinical Trials

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  ‘Discredited’ CDC panel weakens endorsement for newborns’ hepatitis B shot

  After initially delaying a vote, ACIP backed a softer stance that dissenting members warned would cause harm to children in the future.

  Updated Dec. 5, 2025

  Legal

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  Olympus-backed Swan EndoSurgical names Erik Todd as CEO

  Swan highlighted Todd’s experience in scaling robotic platforms, building global engineering organizations and driving innovation across endoscopy and minimally invasive surgery.

  Medical Devices

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  Medtronic’s Hugo surgical robot earns FDA clearance

  With the U.S. authorization for urologic procedures, “there is now choice” for hospitals that want to expand their robotic programs, a company executive said.

  Medical Devices

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  Stryker names Spencer Stiles as COO

  Stiles has worked at Stryker for 27 years, most recently leading the company’s orthopedics business.

  Medical Devices

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  CHS sells lab assets to Labcorp for $194M

  The deal, first announced in July, includes outreach laboratory services in 13 states. CHS will continue to operate inpatient and emergency department labs.

  Diagnostics

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  Olympus reinforces advice over device issue linked to 113 serious injuries

  The company received complaints that the ligation loop can become unintentionally anchored in place.

  Medical Devices

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  Medtronic launches insulin delivery system with Abbott-made sensor

  The partnership is the first time Medtronic has integrated its insulin pumps with a sensor developed outside of the company.

  Medical Devices

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  Akura Medical raises $53M to advance thrombectomy portfolio

  Part of the money will go toward setting up a joint venture in Qatar, whose sovereign wealth fund led the round.

  Medical Devices

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  PitchBook: AI tuck-in deals to drive M&A acceleration in 2026

  Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.

  Medical Devices

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  Medtronic names Jeb Denny as chief medical officer for acute care and monitoring

  Denny leads the unit after Medtronic combined its patient monitoring and respiratory businesses last year.

  Medical Devices

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  Richard Pazdur, FDA drug czar, to retire from agency

  Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.

  FDA

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  Cleveland Diagnostics wins FDA nod for prostate cancer test

  The IsoPSA test is intended to help assess whether patients with elevated PSA levels should go on to receive a biopsy procedure.

  FDA

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  FDA flags risk from dropped BD Alaris pumps after 2 injury reports

  BD told customers to immediately remove from use any devices they drop or severely jar.

  Medical Devices

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  Profile

  Building a better robot: How Virtual Incision plans to challenge Intuitive

  Led by former Intuitive executive Jim Alecxih, Virtual Incision expects the miniaturized design of its robot to stand out in an increasingly crowded field of challengers.

  Medical Devices

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  CMS finalizes competitive bidding changes to diabetes devices

  AdvaMed supported adjustments made from a draft version but still has concerns about the impact on patient access.

  Medical Devices

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  J&J’s US orthopedic leader leaves amid DePuy spinout process

  Leslie Storms started a new role on Monday as president of Ethos Veterinary Health.

  Medical Devices

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  CMS covers cardiac ablation in ambulatory surgery centers

  Extending Medicare reimbursement for cardiac catheter ablation to settings outside the hospital is expected to boost procedure volumes and benefit Abbott, Boston Scientific, J&J and Medtronic.

  Medical Devices

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  OIG report finds Medicare overpaying for CGMs and supplies

  The CMS could use its competitive bidding program to address price concerns, after payments for the devices swelled over five years, the government watchdog said.

  Medical Devices

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  Lawmakers propose Medicare reimbursement pathway for AI devices

  AdvaMed supports the legislation, which is intended to ensure AI-enabled devices receive an accurate CMS payment code.

  Medical Devices

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  Medtronic taps Jim Peichel as CTO

  Peichel, who has worked at Medtronic for more than 25 years, succeeds Ken Washington, who retired earlier this month.

  Medical Devices

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  Abbott issues correction for millions of glucose sensors

  The problem applies to Abbott’s Libre 3 and Libre 3 Plus sensors. The company said it has received reports of 736 severe adverse events and seven deaths.

  Medical Devices

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