The FDA was all in on AI. Will that change?

High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

By Kelly Bilodeau • July 29, 2026

Freenome secures FDA nod for blood-based colorectal cancer test

Abbott will market Freenome’s SimpleScreen CRC test in the U.S., alongside its Cologuard stool test. SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening.

By Susan Kelly • July 27, 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

Boston Scientific removes stroke prevention catheter after injury

The device, bought during Boston Scientific’s acquisition of Silk Road Medical, has a risk of catheter tip separation during use.

By Elise Reuter • July 27, 2026

Why the FDA’s top spot could sit empty for months

Multiple factors could get in the way of confirming a new commissioner before the midterm elections, experts said, leaving the agency’s long-term initiatives in limbo.

By Susanna Vogel • July 24, 2026

FDA names Dexcom as first participant in digital health pilot

Selected devices will be exempt from certain premarket requirements while manufacturers collect real-world data through Medicare.

By Elise Reuter • July 23, 2026

Philips wins FDA clearance for new pulse oximeter

Philips said its updated device provides accurate readings across a range of skin tones, following concerns that pulse oximeters can be less accurate in people with darker skin pigmentation.

By Elise Reuter • Updated July 22, 2026

Resmed ventilator safety issue linked to 5 serious injuries

The supply of the circuit boards needed to fix the devices is significantly constrained, preventing the company from immediately correcting all affected ventilators.

By Nick Paul Taylor • July 20, 2026

4 takeaways from MDUFA VI draft agreement

The draft agreement outlines the Food and Drug Administration’s goals for medical device reviews from 2028 to 2032.

By Elise Reuter • July 9, 2026

J&J wins FDA approval for dual-energy ablation catheter

Johnson & Johnson expects U.S. physicians to perform the first procedures with the device this summer as it starts a phased commercial rollout.

By Nick Paul Taylor • July 9, 2026

Top diabetes tech stories from the first half of 2026

Diabetes technology news has been off to a fast start this year. Here are some highlights of MedTech Dive’s coverage from 2026.

By Elise Reuter • July 7, 2026

FDA updates Hologic BioZorb recall, citing 252 injuries

While the company no longer manufactures the radiographic markers, healthcare providers are still advised to monitor patients who have had them implanted.

By Susan Kelly • July 1, 2026

FDA authorizes more devices so far in 2026, but it’s taking longer

Original premarket approvals are taking “substantially longer” than last year, according to a report from BTIG.

By Elise Reuter • July 1, 2026

Edwards wins FDA clearance for LAA clip, setting up competition with AtriCure and Medtronic

Edwards Lifesciences is expected to introduce the new device to surgical heart valve customers this year in a “measured, targeted rollout,” one analyst said.

By Susan Kelly • June 29, 2026

Aidoc wins breakthrough nod for AI that reads chest X-rays

Aidoc is working on an artificial intelligence feature that would analyze chest X-rays and generate preliminary reports for more than 100 findings.

By Elise Reuter • June 26, 2026

FDA drops Whoop warning letter over blood pressure feature

Whoop made changes to its blood pressure insights feature that satisfied the FDA’s requirements for wellness devices.

By Elise Reuter • June 24, 2026

HHS, responding to China’s rise, moves to fast-track early drug research

A series of newly planned reforms are designed to entice companies to start early trials in the U.S. rather than overseas.

By Jonathan Gardner • June 24, 2026

FDA posts early alert over device used with Impella heart pumps

J&J’s Abiomed and manufacturing partner Oscor warned of a bleeding risk from devices used to introduce catheters to the body. 

By Nick Paul Taylor • June 22, 2026

Zoll receives FDA warning letter over quality concerns

The FDA cited problems with some of Zoll’s ventilators, automated external defibrillators and electrodes.

By Elise Reuter • Updated June 22, 2026

Distalmotion, in US push, adds more robotic gynecology indications

The Swiss robotic surgery company, which is rolling out its Dexter system in the U.S., said the new indications will help ASCs maximize use of the system.

By Susan Kelly • June 17, 2026

FDA warns breast biopsy needle shortage to continue into 2027

The shortage follows Hologic removing certain breast biopsy needles from the market in January.

By Elise Reuter • June 17, 2026

In a first, Dexcom’s OTC glucose sensor is cleared for kids

The Stelo over-the-counter glucose monitor can now be used by children as young as two years.

By Elise Reuter • June 15, 2026

Rethinking FDA audit readiness: A faster path to sustainable compliance

Why continuous audit readiness helps MedTech organizations move faster—without sacrificing confidence or control.

June 15, 2026

Penumbra’s FDA nod for clot removal tech a win for Boston Scientific

The stroke treatment could contribute about $100 million in incremental revenue over time to Boston Scientific, the buyer of Penumbra, one analyst said.

By Susan Kelly • June 12, 2026

J&J recalls Impella controllers over hardware issues

The correction is the latest recall that J&J’s Abiomed has issued in recent years for Impella devices and controllers.

By Nick Paul Taylor • June 12, 2026

Medtronic gets FDA nod for updated pulse oximetry system

The changes support accuracy across diverse patient populations, skin tones and clinical care settings.

By Nick Paul Taylor • June 9, 2026