News
The day's medical technology news, checked and attributed.
Cooper Companies CEO Albert White Steps Down; Rosebrough Named Executive Chair
The contact lens and fertility company began a CEO search and reshaped its board weeks after an activist investor pressed for leadership changes.
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Boston Scientific Cuts 2026 Guidance for a Third Time After Cyberattack
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Heat Packs and Heating Pads Make Up 83% of FDA Reports on Physical Therapy Devices
A study of a decade of MAUDE reports on electrophysical agents found one product line alone accounted for more than a third of the reports.
FDA Device Center Lost 22% of Staff and Is Rehiring, Director Tarver Says
CDRH director Michelle Tarver told The MedTech Conference the center has beaten its fiscal 2026 user-fee hiring target but is "not done" rebuilding.
AdvaMed Plans Industry Cybersecurity Standards, Eyes Tariffs and FDA Staffing
At The MedTech Conference in Boston, the trade group's leaders said a year of cyberattacks on device makers has pushed security to the top of their agenda.
BMJ Study Finds Gaps and Delays in Bulk Device Adverse Event Reports to FDA
Researchers who reviewed six years of summary reports in the FDA's MAUDE database found that most named no device problem and more than half arrived after the 30-day deadline.
Siemens Healthineers Ends General Ultrasound Sales to Focus on Procedural Imaging
The company has stopped selling its Acuson Sequoia, Redwood, Juniper and Maple systems and will concentrate on ultrasound used to guide heart procedures.
BD Pledges $19 Billion US Investment in Supply Chain Pact With Federal Government
The syringe and needle maker says the agreement shields covered products from future Section 232 tariffs if it meets milestones that have not been made public.
Stryker Names COO Spencer Stiles to Succeed Kevin Lobo as CEO
Lobo, who has led the orthopedics and surgical equipment maker since 2012, will become executive chair of the board on January 1, 2027.
FDA Opens Nationwide Recruitment for Advisory Committee Members and Consumer Representatives
Two Federal Register notices seek scientific voting members and consumer representatives for panels that review drugs, vaccines, biologics and medical devices, after a year of sharply fewer meetings.
GE HealthCare Hires Medtronic's Rodolphe Katra as Global Chief AI Officer
Katra fills the post left by Parminder Bhatia, GE HealthCare's first chief AI officer, who moved to Edwards Lifesciences in July.
Senators Press FDA Nominee Heidi Overton on Independence at Confirmation Hearing
The White House aide told the Senate HELP Committee she would follow statutory review standards and look at every FDA advisory committee rather than shut any down.
Medtech Canada Asks Governments to Keep Medical Devices Out of US-Canada Trade Fight
The industry group responded to a September 16 presidential memorandum that directs US officials to identify Canadian-origin items that could be removed from federal civil procurement.
Dexcom Adds Chief Operating Officer Role to CFO Jereme Sylvain
The glucose-sensor maker filled a post left open when Jake Leach became CEO, days after adding former Stryker finance chief Glenn Boehnlein to its board.
HHS Inspector General Flags Gaps in Screening Medical Equipment Suppliers in Medicare Advantage
The watchdog says out-of-network suppliers that are not enrolled in Medicare get the least scrutiny, and CMS has agreed to or will consider all three of its recommendations.
Zimmer Biomet Promotes Three Executives as Americas Group President Departs
The orthopedic company split its top commercial roles ahead of the 2027 Monogram robot launch and reiterated its 2026 financial outlook.
Siemens Healthineers Completes $43.6 Million PET Detector Plant Expansion in Tennessee
The Rockford campus is the company's only manufacturing site worldwide for the detectors in its PET/CT scanners, and the project is expected to add more than 90 jobs over five years.
Boston Scientific Begins Restoring Shipping After Cyberattack; Backlog Remains
The company says most products are moving again from its major distribution centers, about a week after an attack halted manufacturing, order processing and shipping.
Philips Details $33.7 Million ARPA-H Project to Automate Stroke Clot Removal
The award is one of several under a federal robotics program worth up to $175.3 million that aims to bring thrombectomy to hospitals without stroke specialists.
Qiagen Names Former Filtration Group Chief Jonathan Pratt as CEO
Pratt takes over on September 1 from Thierry Bernard as the diagnostics and life sciences company's supervisory board continues a strategic review.
Trump Names White House Aide Heidi Overton as FDA Commissioner Nominee
Overton, a physician and deputy director of the White House Domestic Policy Council, would replace acting commissioner Kyle Diamantas if the Senate confirms her.
AdvaMed Survey Finds Memory Chip Shortages Squeezing Medtech Makers
The trade group says demand from AI and data centers is driving shortages and price increases, and asks chip suppliers to treat health care as a priority customer.
Intuitive Plans Penang Plant for da Vinci Instruments, With 1,200 Jobs by 2032
The 316,000-square-foot facility, Intuitive's first in Southeast Asia, is expected to open in 2028 and draw close to US$500 million in investment over five years, an executive said.
Cook Medical Says Social Engineering Scam Gave Outsider Access to Company Systems
The privately held device maker said customer contact details and internal files were involved in the July 2 incident, but that operations and products were not affected.
Danaher Names Diagnostics Chief Julie Sawyer Montgomery CEO as Rainer Blair Retires
The executive who led the company's Masimo acquisition will take over on Oct. 1, with Blair staying on as a senior adviser until March 2027.
Henry Schein Replaces Executive Committee as Three Longtime Leaders Step Down
New CEO Fred Lowery is forming a new leadership team and folding the global supply chain into distribution, while the COO, chief strategy officer and supply chain chief move to advisory roles.
Siemens Healthineers Names Enterprise Services Chief João Seabra Head of the Americas
Seabra, a 25-year company veteran based in Portugal, will move to the US to succeed John Kowal on Oct. 1, the latest step in a leadership reshuffle the company began in May.
FDA Publishes Reorganization Centralizing Administration as Inspector Changes Loom
A Federal Register notice signed by HHS Secretary Robert F. Kennedy Jr. lays out a new agency structure, as NOTUS reports the plan will move administrative work to a shared-service model and make field inspectors generalists from Oct. 1.
Vicarious Surgical Shareholders Approve Wind-Down of Robot Developer
The single-port surgical robot company has handed its assets to a liquidation trust, dismissed its top executives and plans to dissolve after failing to find funding or a buyer.
Whoop Hires FDA Digital Health Advisory Committee Chair Ami Bhatt as Chief Medical Officer
The cardiologist, who led the FDA's first digital health advisory committee and was the American College of Cardiology's innovation chief, fills a post that had been vacant since 2022.
Abbott Investigates Cyber Incident in Cancer Diagnostics Business From Exact Sciences
The company said unauthorized access was limited to legacy Exact Sciences systems and did not affect operations, while it also looks into a separate claim involving a lab customer portal.
Zimmer Biomet Names Alcon Executive Chintan Desai President of Asia Pacific
Desai replaces longtime regional chief Sang Yi, who leaves on Aug. 28, as the orthopedics company reworks how it sells in markets including China.
Illumina Names New Chief Commercial Officer and Chief Legal Officer
Former Caris Life Sciences commercial chief Mike Sullivan starts July 20, and former Align Technology legal chief Julie Coletti joins on Aug. 3.
AdaptHealth Says Hackers Took Patient Data After Contractor Session Was Compromised
The home medical equipment supplier told the SEC that a social engineering attack gave a threat actor access to patient management systems and that the full scope of the stolen data is not yet known.