Zimmer Biomet expects the Monogram deal to meet its financial and strategic criteria, be neutral to adjusted earnings per share from 2025 through 2027 and become accretive thereafter.

Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting...

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

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In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the...

The Elecsys pTau181 test, which requires only a blood sample, provides a less invasive alternative to cerebral spinal fluid procedures. A negative result could rule out Alzheimer’s and help patients...

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access...

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight...

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Among early cancer screening tests, SpotitEarly stands out by combining dogs’ superior sense of smell with machine learning. SpotitEarly plans two US clinical trials for breast and lung cancer aiming...

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The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses...

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Kevin Lobo, chairman and CEO of Stryker said that the company is not as exposed to China as others and has manufacturing operations in Europe, influencing the overall tariff impact.

At an Aug. 4 public meeting on MDUFA VI, FDA officials, industry representatives, and patient advocates outlined their priorities for the next user fee agreement, highlighting goals such as improved...

The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout...

The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.

Without change, the implementation of the MDR and IVDR could hit another wall.