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 • June 18, 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

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

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

Medtronic seeks clearance for Hugo surgical robot in more indications

Securing 510(k) authorization would position Medtronic to compete with Intuitive in major robotic surgery markets.

By Nick Paul Taylor • June 4, 2026

J&J recalls Impella heart pumps after patient dies

Johnson & Johnson asked customers to quarantine and return affected products. A spokesperson said J&J conducted quality system audits as part of its integration of Abiomed that resulted in some field actions.

By Nick Paul Taylor • May 29, 2026

J&J corrects Impella controller over issue linked to 2 injuries, 1 death

The controller can stop for about 35 seconds, during which time the patient is unsupported by the heart pump.

By Nick Paul Taylor • May 26, 2026

Guardant wins FDA approval for updated liquid biopsy

The company could secure a higher price for the new test than for its older, narrower product, Wall Street analysts said.

By Nick Paul Taylor • May 21, 2026

Natera wins FDA approval for companion diagnostic

The test will enable physicians to assess if post-surgery cancer patients need to receive treatment to minimize the risk of recurrence.

By Nick Paul Taylor • May 18, 2026

Artera gets FDA clearance for AI breast cancer risk prediction tool

The company launched in 2023 with $90 million in funding from organizations including Johnson & Johnson’s venture capital arm.

By Nick Paul Taylor • May 12, 2026

FDA chief Marty Makary resigns from agency, ending tumultuous tenure

Makary’s exit ends a turbulent run marred by leadership upheaval, mass layoffs, political pressure and public spats with drugmakers.  

By Ben Fidler • May 12, 2026

Bayesian Health gets FDA nod for AI sepsis detection tool

Created by Johns Hopkins University researchers, the early warning system for sepsis aims to help physicians detect the serious condition earlier.

By Elise Reuter • May 12, 2026

HistoSonics seeks FDA de novo authorization in kidney cancer

Investors including Bezos Expeditions and Thiel Bio supported HistoSonics’ expansion plans last year by participating in a $250 million financing round.

By Nick Paul Taylor • May 12, 2026

FDA warns of neurosurgical supply disruptions

Interruptions in the supply of neurosurgical patties, sponges and strips are expected to continue through 2026.

By Elise Reuter • May 6, 2026

Abbott gets FDA nod, CE mark for AI-enabled imaging device

The device joins a portfolio of vascular technologies that generated 9.5% sales growth on a comparable basis in the first quarter.

By Nick Paul Taylor • May 4, 2026

FDA advises users of Trividia glucometer to switch to alternatives

The potential for error code confusion to cause delayed or improper treatment led the FDA to recommend users transition to other blood glucose meters.

By Nick Paul Taylor • April 30, 2026

4 studies to know from HRS 2026

Boston Scientific, Abbott and Medtronic shared new cardiac device data at the annual Heart Rhythm Society meeting, where market share shifts in pulsed field ablation were on analysts’ minds.

By Susan Kelly • April 27, 2026

CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices

The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class III breakthrough medical devices.

By Ricky Zipp • April 23, 2026

CDRH Director Tarver previews AI guidance at AAMI event

Michelle Tarver said the device center plans to finalize guidance on AI lifecycle management and provide some initial thoughts on generative AI following an advisory committee meeting last year.

By Elise Reuter • April 22, 2026

RFK Jr. defends HHS tenure, 12% proposed budget cut

Republicans largely praised the HHS secretary’s track record during a marathon of House hearings last week, but some GOP lawmakers raised concerns about proposed budget cuts to the National Institutes of Health.

By Emily Olsen • April 20, 2026

Philips secures FDA clearance for AI-enabled CT system

The company aims to increase its share of the premium CT device market through 2028.

By Nick Paul Taylor • April 17, 2026