FDA flags more Olympus safety problems in import block and warning letter

The FDA import alert broadens the scope of a 2025 import action covering dozens of endoscopes and comes two weeks after a new warning letter identified numerous quality system violations.

By Susan Kelly • Oct. 22, 2026

CDRH on hiring spree after significant staff losses, director says

Dr. Michelle Tarver said the FDA’s device center is filling positions after losing large numbers of clinical reviewers, as well as AI and digital health experts.

By Elise Reuter • Oct. 21, 2026

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Gen AI policy is a White House priority, CDRH digital health leader says

Rick Abramson, director of the FDA’s Digital Health Center of Excellence, said to expect draft guidance in the coming months.

By Elise Reuter • Oct. 21, 2026

5 doctors weigh in on the promise, limitations of Grail’s multicancer test

As the closely watched screening test moves closer to Food and Drug Administration approval, MedTech Dive asked cancer experts what encourages and concerns them most about Galleri.

By Susan Kelly • Oct. 19, 2026

FDA clears Sequel’s insulin delivery system in Type 2 diabetes

With Twiist already available in Type 1 diabetes, Sequel has made the automated insulin delivery system available for the Type 2 population.

By Nick Paul Taylor • Oct. 19, 2026

Philips updates instructions for ultrasound system linked to 4 deaths

A software issue can delay use of the Lumify diagnostic ultrasound system in environments without access to Wi-Fi or cellular signal.

By Nick Paul Taylor • Oct. 12, 2026

Edwards’ adjustable heart valve for children lands FDA approval

The device could help young patients avoid multiple open-heart surgeries as they grow, FDA officials said.

By Susan Kelly • Oct. 2, 2026

FDA to prioritize guidance on AI, surgical robots next year

The FDA outlined its A-list and B-list guidance priorities for the 2027 fiscal year.

By Nick Paul Taylor • Oct. 2, 2026

FDA selects first 5 participants for READI-Home initiative

The innovation challenge is focused on developing home devices that could help reduce hospital readmissions.

By Elise Reuter • Oct. 1, 2026

Medtronic reveals cardiac mapping and ablation software clearances

The regulatory authorizations come as Medtronic looks to differentiate itself in the fast-growing pulsed field ablation market targeted by rivals Abbott, Boston Scientific and J&J.

By Nick Paul Taylor • Oct. 1, 2026

FDA issues draft guidance for surgical robots

A two-day public workshop on evaluating robotic surgery systems with autonomous or remote capabilities is also on the agency’s agenda, as telesurgery advances globally.

By Susan Kelly • Sept. 28, 2026

The Next Evolution of TLIF: Where Innovation Meets Clinical Evidence

New evidence, FDA approval and Medicare NTAP status expand Infuse™ bone graft use in TLIF.

By Sara Rivera, VP, Clinical Cranial & Spinal Technologies, Medtronic • Sept. 28, 2026

FDA nominee Overton parries vaccine questions at Senate hearing

Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.

By Jonathan Gardner • Sept. 24, 2026

Grail multicancer detection test wins FDA advisers’ backing

Members of the molecular and clinical genetics panel said the first-of-a-kind blood test should not be used to replace medical guideline-recommended cancer screenings.

By Susan Kelly • Sept. 24, 2026

Cordis wins FDA approval for sirolimus-eluting balloon

The approval gives physicians an alternative to uncoated balloons and Boston Scientific’s paclitaxel-coated device.

By Nick Paul Taylor • Sept. 22, 2026

Cognita Imaging wins FDA contract to test LLMs in evaluating radiology AI

Cognita’s method will test a way of evaluating AI-generated radiology reports as the FDA considers how to regulate generative AI-enabled devices.

By Elise Reuter • Sept. 18, 2026

Neptune Medical secures FDA nod for endoscopy robot

The robot is intended to give physicians more control of the endoscope during a colonoscopy procedure, which can help with detection and removal of lesions.

By Susan Kelly • Sept. 18, 2026

FDA clears vessel-sealing device for Medtronic’s Hugo robot

Widely adopted in open and laparoscopic surgeries, the LigaSure instrument is now available for use with the Hugo robotic system.

By Nick Paul Taylor • Sept. 17, 2026

Human factors isn’t a checkbox: What FDA’s eSTAR requirements mean for MedTech submissions

FDA’s eSTAR framework raises the bar for documenting human factors and use-related risk.

By Di Lu, Associate Director, Regulatory Affairs | Human Factors and Usability Engineering at IQVIA MedTech • Sept. 14, 2026

4 questions about the FDA’s approach to generative AI

The medtech industry is awaiting FDA guidance on generative AI. The agency has sought feedback in advisory meetings and a discussion paper as the technology becomes more prevalent.

By Elise Reuter • Sept. 9, 2026

Abbott wins FDA approval for dual-energy ablation catheter

CEO Robert Ford has said the atrial fibrillation treatment, along with the company's Volt PFA device, is expected to help Abbott regain market share in electrophysiology.

By Susan Kelly • Sept. 8, 2026

Boston Scientific recall of spinal cord stimulator leads tied to more than 1,000 injuries

A problem with the leads could cause inadequate stimulation, Boston Scientific said. In the worst case, leads may need to be removed or replaced.

By Susan Kelly • Sept. 4, 2026

Medtronic recalls pH monitoring capsule linked to 184 serious injuries

For the second time in two years, Medtronic has pulled capsules from the market over a fault that could obstruct patients’ airways.

By Nick Paul Taylor • Aug. 28, 2026

J&J’s latest Impella recall tied to 3 deaths, 37 injuries

Hospitals can use automated controllers in inventory while waiting for service from J&J’s Abiomed business to ensure patients who need Impella heart pumps can still receive care.

By Susan Kelly • Aug. 27, 2026

Roche, Eli Lilly get FDA nod for new Alzheimer’s blood test

Labcorp and Quest Diagnostics both plan to offer the test, which secured CE mark certification earlier this year.

By Susan Kelly • Aug. 25, 2026