Medical Devices
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Retrieved from Aerial Lens on October 04, 2024
Baxter unsure when North Carolina facility hit by Hurricane Helene will be operational
As access challenges to the site continue, Baxter has limited purchases of certain products to avoid stockpiling, manage inventory and minimize disruption to patient care.
By Ricky Zipp • Oct. 4, 2024 -
Patrik Stollarz / Staff via Getty Images
Independent lab fires back after Philips sues over testing results
PSN Labs called for a jury trial, claiming Philips is attempting to deflect attention away from its own “failures, negligence, concealment and recklessness.”
By Elise Reuter • Oct. 3, 2024 -
Explore the Trendline➔
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Permission granted by Becton Dickinson
BD agrees to settle most of its hernia mesh litigation
The settlement terms are confidential, BD said. The company disputes the lawsuit’s allegations and backs its product designs.
By Susan Kelly • Oct. 3, 2024 -
Jolygon via Getty Images
FDA authorizes Pi-Cardia’s valve-in-valve TAVR device
Pi-Cardia designed the Shortcut device to mitigate the risk of coronary artery obstruction by splitting aortic valve leaflets before valve placement.
By Nick Paul Taylor • Oct. 3, 2024 -
Patrik Stollarz / Staff via Getty Images
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.
By Elise Reuter • Oct. 2, 2024 -
Getty Images/Staff via Getty Images
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.
By Susan Kelly • Oct. 2, 2024 -
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.
By Nick Paul Taylor • Oct. 2, 2024 -
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.
By Susan Kelly • Oct. 1, 2024 -
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.
By Ricky Zipp • Oct. 1, 2024 -
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.
By Nick Paul Taylor • Oct. 1, 2024 -
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.
By Elise Reuter • 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.
By Nick Paul Taylor • Sept. 30, 2024 -
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.
By Susan Kelly • Sept. 30, 2024 -
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.
By Emily Olsen • Sept. 27, 2024 -
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.
By Nick Paul Taylor • Sept. 27, 2024 -
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.
By Elise Reuter • 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.
By Nick Paul Taylor • Sept. 26, 2024 -
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.
By Elise Reuter • Sept. 25, 2024 -
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.
By Susan Kelly • Sept. 25, 2024 -
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.
By Susan Kelly • Sept. 24, 2024 -
magicmine via Getty Images
Recalled heart devices had limited clinical testing, study finds
Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.
By Elise Reuter • Sept. 24, 2024 -
libre de droit via Getty Images
Route 92 Medical raises $50M to fund global sales of stroke devices
The latest investment extends an earlier funding round, bringing the total raised to $82 million. Novo Holdings, the controlling shareholder of Novo Nordisk, joined returning investors.
By Nick Paul Taylor • Sept. 24, 2024 -
Getty Images via Getty Images
Stryker adds devices to remove brain tumors, clots with Nico buy
Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue.
By Nick Paul Taylor • Sept. 23, 2024 -
Sarah Silbiger via Getty Images
FDA posts draft guidance on biocompatibility testing of devices
To promote consistency and reliability in premarket submissions, the FDA shared approaches for device biocompatibility analysis.
By Nick Paul Taylor • Sept. 23, 2024 -
Scott Olson/Getty Images via Getty Images
Deep Dive4 steps to minimize the threat of legacy medical devices
Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.
By Ricky Zipp • Sept. 23, 2024
