SEC ends probe of Illumina’s Grail acquisition

The DNA sequencing company also cut its 2025 earnings outlook to reflect the impact of tariffs on its business.

By Susan Kelly • May 9, 2025

FDA, aiming to speed scientific reviews, names chief AI officer

Commissioner Martin Makary also said the agency would roll out a generative AI system across its centers that will help FDA scientists spend less time on repetitive tasks.

By Susan Kelly • May 9, 2025

ADA’s Osagie Ebekozien on diabetes tech for Type 2, new CGM standards

Ebekozien, chief quality officer of the American Diabetes Association, said the nonprofit is seeing a shift with more devices authorized for Type 2 diabetes.

By Elise Reuter • May 9, 2025

Bausch + Lomb receives CE mark for Luxlife intraocular lens

The company plans to launch the lens, which supports vision at all distances, in Europe in the coming weeks.

By Nick Paul Taylor • May 9, 2025

US, UK reach deal on tariffs, market access

The deal includes a reduced tariff for some U.K. automobiles and is the first the Trump administration has secured after unveiling its reciprocal tariff plan in April.

By Philip Neuffer • May 8, 2025

Masimo says cyberattack has impacted its ability to fulfill orders

The maker of patient monitoring devices is working to bring the affected portions of its network back online and restore normal business operations.

By David Jones • May 8, 2025

Siemens Healthineers lowers earnings forecast on expected tariff hit

The company expects a tariff impact of up to 300 million euros, with the biggest hit from European goods going to the U.S.

By Nick Paul Taylor • May 8, 2025

Masimo finds buyer for consumer audio business

In addition to offloading the Sound United segment for $350 million, the company lowered its 2025 profit forecast to account for tariffs.

By Susan Kelly • May 7, 2025

AdvaMed calls for ‘zero for zero’ medtech tariffs between US and UK

AdvaMed and its British counterpart called for urgent action to ensure the situation “does not devolve into a crisis.”

By Nick Paul Taylor • May 7, 2025

RFK’s FDA layoffs could slow safety communications, experts warn

The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety alerts.

By Elise Reuter • May 6, 2025

Philips cuts earnings forecast after calculating $340M tariff hit

CEO Roy Jakobs said tariff impacts require the company to accelerate localization of production in the U.S.

By Nick Paul Taylor • May 6, 2025

US semiconductor import probe looms over medtech industry

Medical device manufacturers could face increased costs if the Commerce Department's Section 232 probe leads to tariffs on chips.

By Susan Kelly • May 6, 2025

Zimmer Biomet expects $60M to $80M tariff impact this year

The orthopedics company lowered its earnings forecast, accounting for the tariffs and closing the acquisition of Paragon 28.

By Elise Reuter • May 6, 2025

Edwards gains expanded TAVR label for asymptomatic patients

The medical technology company expects the new indication to increase sales in its transcatheter aortic valve replacement business with more patients becoming eligible for the treatment.

By Susan Kelly • May 5, 2025

Trump policies are upending healthcare. Track the effect on the medtech industry here.

The FDA has rolled out an AI tool agency-wide, while a proposed HHS budget shows large cuts for the National Institutes of Health.

By MedTech Dive Staff • Updated June 6, 2025

Stryker expects $200M tariff hit, lowers earnings forecast

CEO Kevin Lobo said that without the tariffs, the company would have “raised our earnings without question.”

By Elise Reuter • May 2, 2025

Intuitive wins new FDA nod for single port robot; Resmed buys diagnostic facility

Intuitive secured a single port robot clearance, Resmed bought sleep testing facility Virtuox, and Precision Neuroscience hired an executive to support its BCI commercialization plans.

By Nick Paul Taylor • May 2, 2025

Abbott integrates diabetes data into Epic’s electronic health records

Linking the systems will allow clinicians to view glucose data captured by Libre glucose sensors within Epic’s systems.

By Nick Paul Taylor • May 1, 2025

GE Healthcare slashes 2025 profit forecast on tariff impact

The full-year tariff impact of 85 cents per share would have more than doubled without mitigation actions underway, executives said on the earnings call.

By Susan Kelly • April 30, 2025

Senators call for investigation into BCI privacy

In a letter to the FTC, three Democratic senators called for privacy standards for brain computer interface technology.

By Elise Reuter • Updated April 30, 2025

Medtronic wins FDA approval for defibrillation lead

Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, according to Medtronic.

By Nick Paul Taylor • Updated May 5, 2025

4 PFA studies in the spotlight at Heart Rhythm 2025

Boston Scientific, Medtronic, Abbott and J&J unveiled new data for their PFA devices in tandem with the Heart Rhythm Society’s annual meeting.

By Susan Kelly • April 29, 2025

ICU Medical receives FDA warning letter over infusion pumps

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

By Nick Paul Taylor • April 29, 2025

Thermo Fisher commits $2B to US manufacturing

The company said the investment will create high-paying jobs and add lab services capacity to its domestic healthcare supply chain.

By Nathan Owens • April 28, 2025

Ashley McEvoy named Insulet CEO

McEvoy, the former leader of Johnson & Johnson’s medtech business, started immediately. Jim Hollingshead, who was CEO of Insulet for three years, resigned on Monday but will work as a consultant.

By Elise Reuter • April 28, 2025