The Latest
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Philips issues fix for ventilator problems linked to 9 injuries, 1 death
Philips is asking customers to immediately install a software update to address several new and previously reported safety issues, the FDA said.
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Integer sells non-medical business for $50M
After making nearly $550 million worth of acquisitions in the past few years, the medical device contract manufacturer will use proceeds from the sale to pay down debt.
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Courtesy of Siemens Healthineers
Siemens Healthineers wins FDA approval for 3D mammography system
The 3D capabilities are part of Siemens’ first completely redesigned mammography platform in over a decade.
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halbergman via Getty Images
Top medtech conferences in 2025
The lineup includes industry wide conferences and events covering the latest medtech trends in diabetes, orthopedics, cardiac care and surgical robotics.
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Courtesy of Synchron
Synchron’s brain-computer interface tech meets safety goal
The six-patient trial also indicated the device worked, according to Synchron, with the conversion of brain signals to motor outputs allowing people to perform digital tasks.
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Stringer via Getty Images
GE Healthcare gets FDA nod for new PET imaging agent
Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.
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Tim Boyle via Getty Images
Baxter closes dialysis solutions facility due to Hurricane Helene damage
More than 2,500 people work at the facility, which is Baxter’s largest manufacturing site. The company is still working to fully assess the damage.
Updated Sept. 30, 2024 -
Sarah Silbiger via Getty Images
Establishment Labs wins FDA approval for Motiva breast implants
Motiva is the first new breast implant to receive premarket approval since 2013, according to Establishment Labs, and enters a market reshaped by safety issues linked to other products.
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Mario Tama / Staff via Getty Images
What’s next at Masimo after CEO Kiani’s exit?
Investors are waiting to learn the next steps for the patient monitoring company after a hard-fought proxy battle, including how a separation of its consumer business could play out.
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Nuthawut Somsuk via Getty Images
Mendaera raises $73M to develop handheld robotics platform
Fred Moll, founder of surgical robotics firms Intuitive Surgical and Auris Health, participated in in the financing round, along with previous Auris investors.
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Permission granted by Peyton Helbert / AAMI
Lawmakers call for investigation of former FDA device director
The letter to the health department watchdog follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.
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SolStock via Getty Images
Remote patient monitoring in Medicare needs more oversight: OIG
Regulators say Medicare needs more data and oversight to avoid fraud and misuse. Digital health advocates argue the service is still crucial for managing chronic conditions.
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Tom Brenner via Getty Images
Congress again delays steep cuts in Medicare lab payments
The American Clinical Laboratory Association welcomed the reprieve but said long-term reform of the Medicare payment system is still needed.
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Medtech’s top executive moves in 2024
Recent executive changes include former Medtronic CFO Karen Parkhill leaving for HP and Masimo CEO Joe Kiani resigning. Check out MedTech Dive’s roundup of leadership movement in 2024.
Updated Sept. 26, 2024 -
Sarah Silbiger via Getty Images
FDA proposes reclassifying hepatitis B assays
The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.
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Masimo CEO, founder Kiani resigns
Michelle Brennan was named acting CEO of the patient monitoring company following Joe Kiani’s defeat in a proxy battle with an activist investor.
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Courtesy of Siemens Healthineers
Medtronic, Siemens Healthineers partner on spine surgery
Siemens Healthineers will integrate its robotic X-ray imaging system with Medtronic’s spine surgery suite.
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Courtesy of Roche
Roche launches test that detects 12 respiratory viruses
Roche’s TAGS technology allows tests to simultaneously detect multiple respiratory viruses, including influenza A and B, RSV and the COVID-19 virus.
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Permission granted by FDA
FDA names new head of medical device evaluation and quality
Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.
