Medical Devices: Page 17
-
Courtesy of Boston Scientific
Boston Scientific blood-blocking agent tied to additional 2 deaths, 8 injuries
After a February recall, Boston Scientific has warned physicians about new safety risks for Obsidio Embolic, which is now connected to a total of 15 injuries and four deaths.
By Nick Paul Taylor • Oct. 21, 2024 -
SciePro via Getty Images
Novocure wins FDA approval for electric field device in lung cancer
Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.
By Jonathan Gardner • Oct. 18, 2024 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
Elise Reuter/MedTech Dive
The Medtech ConferenceTarver, acting CDRH director, sets tone for future of the device center
Former CDRH leader Jeff Shuren told an audience at The Medtech Conference that Michelle Tarver “will make an excellent center director, and quite frankly, the best is yet to come.”
By Elise Reuter • Oct. 18, 2024 -
Courtesy of Intuitive Surgical
Intuitive readies da Vinci 5 for broader launch after placing 110 robots in Q3
BTIG analysts wrote that installations of Intuitive’s new robotic surgery system are “well ahead of lofty” expectations.
By Susan Kelly • Oct. 18, 2024 -
Sarah Silbiger via Getty Images
FDA prioritizes guidance on lab developed tests in 2025 plan
The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.
By Nick Paul Taylor • Oct. 18, 2024 -
Alxpin via Getty Images
Medtech Europe calls for urgent reform of MDR and IVDR
The trade group’s intervention follows news that the new commissioner for Health and Animal Welfare will assess the need for legislative changes.
By Nick Paul Taylor • Oct. 18, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceLegacy medical devices keep regulators up at night
The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem regulators and industry need to work on together.
By Elise Reuter • Oct. 17, 2024 -
Courtesy of CMR Surgical
CMR Surgical gets FDA de novo nod for Versius robot
After expanding in global markets, the U.K.-based company will challenge Intuitive Surgical in the U.S., starting with gallbladder removal procedures.
By Susan Kelly • Oct. 17, 2024 -
Permission granted by Abbott
Abbott CEO sees ‘mass market potential’ for CGMs
Robert Ford’s comments come as new CGMs and insulin pumps continue to roll out in the diabetes tech space, including over-the-counter glucose sensors.
By Ricky Zipp • Oct. 16, 2024 -
RiverNorthPhotography via Getty Images
FTC increases premerger reporting requirements over provider objections
Companies will be required to disclose more information about minority investors and past M&A activity. Provider groups said the new requirements would be burdensome for hospitals.
By Susanna Vogel • Oct. 16, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceFDA, Health Canada give sneak peek into future AI regs
Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.
By Elise Reuter • Oct. 16, 2024 -
Courtesy of Johnson & Johnson
J&J’s recent medtech buys help to prop up devices unit
Johnson & Johnson’s medtech acquisitions over the past year have fueled growth for its cardiovascular group, offsetting challenges in businesses like orthopedics and surgery.
By Ricky Zipp • Oct. 15, 2024 -
FatCamera via Getty Images
Hologic to buy Gynesonics for $350M to acquire fibroid system
Gynesonics’ transcervical system uses ultrasound guidance and radiofrequency energy to ablate fibroids without the need for an incision.
By Nick Paul Taylor • Oct. 15, 2024 -
Courtesy of Medtronic
Medtronic to evaluate Affera in ventricular tachycardia
The FDA approved an early feasibility study of Medtronic’s Affera mapping and ablation system and Sphere-9 catheter in patients with ventricular tachycardia, an abnormal heart rhythm.
By Susan Kelly • Oct. 15, 2024 -
Mario Tama via Getty Images
J&J, Abbott and Intuitive kick off latest medtech earnings season
From pulsed field ablation to diabetes tech and surgical robots, the updates will provide an early look at how key medtech markets performed last quarter.
By Nick Paul Taylor • Oct. 14, 2024 -
Courtesy of Metro Toronto Convention Centre
The Medtech Conference4 trends to watch at Advamed’s The Medtech Conference
As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential election loom over the industry.
By Elise Reuter • Oct. 14, 2024 -
J. Michael Jones via Getty Images
Fresenius Medical Care increasing IV, dialysis solutions production to alleviate shortages
B. Braun and Fresenius Medical Care said they will make more crucial products as the U.S. faces shortages following Hurricane Helene’s damage to a Baxter manufacturing facility.
By Ricky Zipp • Oct. 11, 2024 -
Courtesy of Solventum
Solventum names Egeland as chief medical officer
Ryan Egeland, former CEO and co-founder of Crossfire Medical, rounds out the leadership team for the 3M spinoff.
By Elise Reuter • Oct. 11, 2024 -
Courtesy of Abbott
Abbott enrolls pivotal PFA study 4 months ahead of schedule
The company reported the enrollment milestone alongside news that it received clearance to sell its Advisor HD Grid X Mapping Catheter and started a trial of its Tactiflex Duo Ablation Catheter.
By Nick Paul Taylor • Oct. 11, 2024 -
Prostock-Studio via Getty Images
Shiratronics raises $66M for trial of neuromodulation migraine device
The funding will support the trial, premarket approval application and initial commercial launch of a system that could interrupt or change the transmission of pain signals to the brain.
By Nick Paul Taylor • Oct. 10, 2024 -
Retrieved from Aerial Lens on October 10, 2024
Baxter ups IV fluid allocations amid supply shortages
As hospitals around the U.S. report IV fluid shortages, Baxter has increased supply allocations for direct customers and distributors. It plans on returning to 90% to 100% allocation of certain supplies by the end of 2024.
By Ricky Zipp • Oct. 10, 2024 -
Permission granted by CMR Surgical
CMR Surgical CEO Bose steps down
Massimiliano Colella, who joined the surgical robotics firm in late 2023, was named interim CEO.
By Susan Kelly • Oct. 10, 2024 -
Daniel Karmann/Picture-Alliance/DPA/AP
Deep DiveThe number of AI medical devices has spiked in the past decade
The FDA has authorized nearly 1,000 medical devices with artificial intelligence features as companies including GE Healthcare and Siemens Healthineers build out their AI efforts.
By Elise Reuter , Jasmine Ye Han • Oct. 9, 2024 -
Tim Boyle via Getty Images
AHA asks Biden administration for relief amid IV fluid shortage from Hurricane Helene
Hospitals have been contending with shortages of the life-saving supplies after Hurricane Helene damaged Baxter's manufacturing plant in North Carolina, according to the American Hospital Association.
By Susanna Vogel • Oct. 9, 2024 -
Retrieved from Aerial Lens on October 08, 2024
Baxter says no structural damage at North Carolina site hit by Hurricane Helene
The facility also has access to water and power. Baxter expects to share production plans over the next two weeks.
By Elise Reuter • Oct. 8, 2024
Previous
