EU proposal would simplify Medical Device Regulation

If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare disease treatments.

XCath targets better brain aneurysm outcomes with robotic approach

The Houston-based startup is developing capabilities for endovascular aneurysm repair and stroke treatment that it hopes can bridge a skills gap and get patients treated faster.

Pulse Biosciences wins FDA approval to begin PFA catheter study

Shorter, nanosecond pulses for treating atrial fibrillation differentiate the company’s approach from existing pulsed field ablation systems on the market.

Moon Surgical adds 5G and Wi-Fi to Maestro robots for cloud-based AI

The company provided an update on its efforts to win market share, revealing that Maestro has been used to treat over 2,300 patients across all sites of care.

Robot developers make strides in 2025

Medtronic and CMR Surgical got the FDA’s green light this month, while SS Innovations applied for clearance. Catch up on the latest in surgical robotics in this coverage roundup.

House passes Republican health bill without ACA subsidy extension

The legislation makes no mention of the financial assistance, setting the subsidies up to lapse in just a few weeks.

Dialysis cannulation can be difficult. A startup is working to improve it.

X9 is building an ultrasound-guided device used to simplify the process of inserting a needle for cannulation.

CMR Surgical gains FDA clearance for new robot

As competition intensifies among surgical robot makers, CMR said its soft tissue platforms are the second most used systems in the world.

Wyden pushes EHR vendors to adopt data privacy features

The influential senator pressed 10 health IT and EHR firms to implement features that give patients more control over the flow of their health data.

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.