The Latest
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Boston Scientific continues M&A run with Cortex buy
Cortex adds to Boston Scientific’s electrophysiology portfolio amid treatment shifts in the space driven by new pulsed field ablation devices.
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Medtronic settles pulse oximetry lawsuit alleging inaccuracies
Roots Community Health has sued 12 other firms, including GE Healthcare, CVS and Walgreens, and called for manufacturers and the FDA to ensure the devices work for everyone.
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Zimmer licenses NeuroOne brain ablation system
NeuroOne will get $3 million upfront for an exclusive license to distribute its radiofrequency ablation system designed to treat neurological disorders such as epilepsy and Parkinson's disease.
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EU posts guidance on ethylene oxide in device sterilization
The document clarifies that EtO falls within the scope of the Medical Device Regulation and the In Vitro Diagnostic Regulation.
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FDA clears iRhythm’s second 510(k) in response to warning letter
However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation efforts are further along.
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J&J Medtech CIO Larry Jones resigns
Jones, who has led connectivity solutions for J&J’s surgical robots, announced his departure on LinkedIn.
Updated Nov. 1, 2024 -
Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.
Patient advocates are hoping for change under new director Michelle Tarver, while industry groups look to build on former director Jeff Shuren’s leadership.
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Deep Dive
Tech companies pitch AI platforms for healthcare, outline plans for responsible rollout
Google, Microsoft and GE Healthcare say they’ll power the next wave of AI advancement. But executives are split on how to offer the tools to providers responsibly — and whether all clinicians are equally ready for them.
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Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study
Analysts said the findings complicate the outlook for a U.S. launch of Boston Scientific's aortic valve replacement device.
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Edwards, Medtronic and Inari share trial data at TCT conference
The three medtech firms unveiled new data this week during TCT 2024 in Washington, D.C. Here’s what the results mean for the companies and their device markets.
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Exactech files for Chapter 11, agrees to investor buyout
The filing follows Exactech’s failure to settle product liability claims from about 2,600 patients in response to recalls of orthopedic devices.
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Stryker, Zimmer outline different M&A strategies
Stryker CEO Kevin Lobo told investors M&A will be the “number one use of our cash going forward,” while Zimmer Biomet CEO Ivan Tornos emphasized internal product development for growth.
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Deep Dive
AI could be a game changer, but healthcare needs to be ‘exceedingly careful’
Artificial intelligence tools could help solve workforce challenges. Implementation, however, can be difficult, pushing organizations to consider less risky administrative and back-office tasks first.
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Edwards data show benefit of early TAVR over ‘watchful waiting’
Study author Philippe Genereux said the trial data “shatter 60 years of ingrained belief on the treatment for severe aortic stenosis.”