What medtech firms can learn from Whoop’s warning letter

An FDA warning letter about the wearable company’s blood pressure feature raises questions about the blurring lines between medtech and wellness.

FDA pilots allowing digital health devices access to CMS payment program

Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.

Natera acquires Foresight Diagnostics for up to $450M

Foresight’s technology will be integrated into Natera’s Signatera platform and is expected to be launched for clinical use in 2026.

GE HealthCare, Mayo Clinic expand partnership around radiology research

Ben Newton, GE HealthCare’s global head of oncology, said the partnership will shift radiation therapy from a “one-size-fits-all” approach to a personalized method.

Medtronic changes investor relations leadership ahead of diabetes spinout

Ryan Weispfenning has elected to take up the challenge of creating and leading the investor relations function at the planned new diabetes company.

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.

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. 

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.

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.

‘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

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.

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.

Stryker names Spencer Stiles as COO

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

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.