MedTech Dive

Our goal is to give busy professionals a quick overview of the medtech industry in just 60 seconds. We share the latest industry news and offer original insights. Our editorial team works throughout the day to analyze key news stories and produce detailed feature articles. Additionally, you can explore our site for information on industry events, job opportunities, and more.

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J&J may take a softer tariff hit after US-China pause, CFO says

3 days ago | medtechdive.com | Susan Kelly

This audio is auto-generated. Please let us know if you have feedback. Johnson & Johnson CFO Joseph Wolk, at the Bernstein investor conference last week, tempered the company's expectation that it would suffer a $400 million tariff impact this year. Wolk gave the update after the U.S. and China reached a temporary agreement to pause escalating tariff rates between the two countries for 90 days.
Clairity receives FDA OK for breast cancer risk prediction tool

4 days ago | medtechdive.com | Elise Reuter

The Food and Drug Administration has authorized the first artificial intelligence tool to predict patients’ five-year breast cancer risk from a routine mammogram. Boston-based startup Clairity developed the tool, called Clairity Breast. The company plans to launch the risk assessment feature by the end of the year, according to a Monday announcement.
FDA declines to appeal court order that stopped LDT final rule

4 days ago | medtechdive.com | Susan Kelly

This audio is auto-generated. Please let us know if you have feedback. The Food and Drug Administration did not appeal a recent U.S. District Court decision that set aside the agency’s final rule aimed at increasing its authority over laboratory developed tests, according to two lab industry groups. The 60-day window for the FDA to appeal the ruling by the U.S. District Court for the Eastern District of Texas expired over the weekend.
Nvidia’s David Niewolny on the future of AI in medical devices

4 days ago | medtechdive.com | Elise Reuter

As more medical device companies incorporate artificial intelligence, chip designer Nvidia is playing a central role. The company has struck partnerships with top medtech firms including Medtronic, Johnson & Johnson, GE Healthcare and Philips. The uses span a breadth of technologies.
Bivacor wins FDA breakthrough nod for titanium total artificial heart

5 days ago | medtechdive.com | Nick Paul Taylor

This audio is auto-generated. Please let us know if you have feedback. Bivacor has received breakthrough designation for its titanium total artificial heart, the company said Friday. The Food and Drug Administration designation could accelerate development of a device that recently kept a man alive for more than 100 days while he waited for a donor heart. Syncardia already sells an artificial heart, and Realheart and Carmat are developing total artificial hearts.
Boston Scientific plans changes to expected $200M tariff hit as situation shifts

1 week ago | medtechdive.com | Nick Paul Taylor

This audio is auto-generated. Please let us know if you have feedback. Boston Scientific is planning to update its $200 million tariff impact forecast in response to changes since it made the prediction last month, CEO Mike Mahoney told investors Wednesday. Mahoney discussed tariffs at a Bernstein analyst event, telling attendees the world is in “a better situation” than when Boston Scientific made its current forecast.
Boston Scientific ends TAVR sales; J&J shares Monarch robot data

1 week ago | medtechdive.com | Elise Reuter

Boston Scientific said Wednesday it plans to end worldwide sales of its transcatheter aortic valve replacement systems, citing regulatory hurdles. The company will discontinue its Acurate Neo2 and Acurate Prime TAVR systems, which are sold in Europe, and will not pursue Food and Drug Administration approval for the devices.
FDA finds Chinese lab copied or falsified data, endangering patients

1 week ago | medtechdive.com | Nick Paul Taylor

This audio is auto-generated. Please let us know if you have feedback. The Food and Drug Administration has accused another Chinese facility of copying results from another study or falsifying data. FDA officials, who published the claims on May 22, accused Sanitation & Environment Technology Institute of Soochow University of wrongdoing after seeing “highly improbable” data from tests the lab performed on guinea pigs.
Abbott wins FDA approval for mitral valve replacement device, teeing up Edwards competition

1 week ago | medtechdive.com | Susan Kelly

This audio is auto-generated. Please let us know if you have feedback. Abbott said Tuesday it received Food and Drug Administration approval for the Tendyne transcatheter mitral valve replacement system to treat calcium buildup in the ring that supports the heart valve. The device is available for patients with severe mitral annular calcification who are not candidates for open heart surgery or transcatheter mitral valve repair.
Zimmer hires former Nevro CEO Kevin Thornal

1 week ago | medtechdive.com | Susan Kelly

This audio is auto-generated. Please let us know if you have feedback. Name: Kevin ThornalNew title: Group president for global businesses and the Americas, Zimmer BiometPrevious title: President and CEO, NevroZimmer Biomet named Kevin Thornal to the newly created position of group president for global businesses and the Americas, effective July 1, the orthopedics device maker said Tuesday.