The Latest
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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.
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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.
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Courtesy of Siemens Healthineers
Earnings & TariffsSiemens 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.
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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.
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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.
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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.
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HHS overhaulRFK’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.
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TrackerTrump policies are upending healthcare. Track the effect on the medtech industry here.
Policies and actions reshaping the healthcare industry began pouring out of President Donald Trump’s White House nearly from day one. Follow the changes affecting the medical device industry.
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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.”
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HHS overhaulState attorneys general sue over ‘unconstitutional’ HHS restructuring
The lawsuit alleges the Trump administration overstepped its authority in reshaping the federal health department and asked the court to reinstate workers laid off last month.
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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.
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Earnings & TariffsPhilips 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.
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Earnings & TariffsZimmer 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.
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Earnings & TariffsCardinal Health cuts employees to offset up to $300M tariff charge
Executives said Thursday that the company has already laid off employees to help mitigate the effects of the Trump administration’s tariff policies.
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Courtesy of Edwards Lifesciences
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.
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News roundupIntuitive 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.
