CMS considers expanding TAVR coverage to asymptomatic patients

Medicare reimbursement for aortic stenosis patients without symptoms could accelerate procedure growth for Edwards Lifesciences, which requested the CMS review, analysts said.

FDA gets mixed feedback on performance monitoring for AI

Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.

FDA needs more staff, authority to oversee device recalls, watchdog finds

“FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the U.S. Government Accountability Office said.

Philips to acquire SpectraWAVE

SpectraWAVE makes technologies to help diagnose and guide treatment decisions for coronary artery disease.

AtriCure treats first patients with dual PFA/RF system

Combining pulsed field ablation and a radiofrequency technique in one platform is expected to reduce procedure times.

Trump calls for federal policy framework preempting state AI laws

The executive order comes as Big Tech pushes back on local AI regulation while pouring billions into building out AI infrastructure and deploying new products.

Senate rejects competing health bills, setting up ACA subsidy lapse

The failure of bills from both sides of the aisle means enhanced subsidies for Affordable Care Act plans will likely expire at the end of the year. Healthcare groups urged lawmakers to extend the subsidies, noting premiums could skyrocket.

Mick Farrell named chair of AdvaMed board

The Resmed CEO will serve a two-year term on the medtech lobbying group’s board.

Intuitive wins 3 new indications for da Vinci SP system

The robotic surgery market leader’s single port system can now be used in inguinal hernia repair, gallbladder removal and appendectomy procedures.

Impulse Dynamics raises $158M to commercialize heart failure device

By strengthening heart contractions, Impulse’s device could improve quality of life, restore functional capacity and enhance tolerance for exercise. 

Teleflex inks deals to sell 3 businesses for $2B

Needham analysts said Teleflex’s inability to secure a price above the low end of their expectations could reflect “the continued poor performance of UroLift.”

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.