Medtech Europe calls for urgent reform of MDR and IVDR

The trade group’s intervention follows news that the new commissioner for Health and Animal Welfare will assess the need for legislative changes.

FDA prioritizes guidance on lab developed tests in 2025 plan

The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.

Legacy medical devices keep regulators up at night

The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem regulators and industry need to work on together.

CMR Surgical gets FDA de novo nod for Versius robot

After expanding in global markets, the U.K.-based company will challenge Intuitive Surgical in the U.S., starting with gallbladder removal procedures.

FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs

Cue Health began the recall of nearly 250,000 COVID-19 test kits in May, shortly after the FDA advised people at home and healthcare professionals not to use the products.

FDA, Health Canada give sneak peek into future AI regs

Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.

Abbott CEO sees ‘mass market potential’ for CGMs

Robert Ford’s comments come as new CGMs and insulin pumps continue to roll out in the diabetes tech space, including over-the-counter glucose sensors.

Health officials outline industry role in AI oversight in JAMA article

FDA Commissioner Robert Califf and two colleagues warned that the “scale of effort” needed to repeatedly evaluate AI models “could be beyond any current regulatory scheme.”

J&J’s recent medtech buys help to prop up devices unit

Johnson & Johnson’s medtech acquisitions over the past year have fueled growth for its cardiovascular group, offsetting challenges in businesses like orthopedics and surgery.

FTC increases premerger reporting requirements over provider objections

Companies will be required to disclose more information about minority investors and past M&A activity. Provider groups said the new requirements would be burdensome for hospitals.

Hologic to buy Gynesonics for $350M to acquire fibroid system

Gynesonics’ transcervical system uses ultrasound guidance and radiofrequency energy to ablate fibroids without the need for an incision.

Medtronic to evaluate Affera in ventricular tachycardia

The FDA approved an early feasibility study of Medtronic’s Affera mapping and ablation system and Sphere-9 catheter in patients with ventricular tachycardia, an abnormal heart rhythm.

4 trends to watch at Advamed’s The Medtech Conference

As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential election loom over the industry.

J&J, Abbott and Intuitive kick off latest medtech earnings season

From pulsed field ablation to diabetes tech and surgical robots, the updates will provide an early look at how key medtech markets performed last quarter.

Digital health deal count declines in Q3, but check sizes stabilize: Rock Health

Startups notched 110 deals in the third quarter, compared with 133 in the second quarter. But average deal size held steady, suggesting investors are making “fewer, more focused bets,” according to the consultancy firm.

Fresenius Medical Care increasing IV, dialysis solutions production to alleviate shortages

B. Braun and Fresenius Medical Care said they will make more crucial products as the U.S. faces shortages following Hurricane Helene’s damage to a Baxter manufacturing facility.

Abbott enrolls pivotal PFA study 4 months ahead of schedule

The company reported the enrollment milestone alongside news that it received clearance to sell its Advisor HD Grid X Mapping Catheter and started a trial of its Tactiflex Duo Ablation Catheter.

Solventum names Egeland as chief medical officer

Ryan Egeland, former CEO and co-founder of Crossfire Medical, rounds out the leadership team for the 3M spinoff.

Baxter ups IV fluid allocations amid supply shortages

As hospitals around the U.S. report IV fluid shortages, Baxter has increased supply allocations for direct customers and distributors. It plans on returning to 90% to 100% allocation of certain supplies by the end of 2024.

CMR Surgical CEO Bose steps down

Massimiliano Colella, who joined the surgical robotics firm in late 2023, was named interim CEO.

Shiratronics raises $66M for trial of neuromodulation migraine device

The funding will support the trial, premarket approval application and initial commercial launch of a system that could interrupt or change the transmission of pain signals to the brain.