Medical Devices
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European Parliament calls for proposals to reform MDR and IVDR by end of Q1
Parliament asked the European Commission to publish acts that address the “most pressing challenges and bottlenecks” of the regulations and propose the “systematic revision” of the legislation.
By Nick Paul Taylor • Oct. 24, 2024 -
Elise Reuter/MedTech Dive
Medtech Conference recap: New CDRH leader details approach; AI and LDTs in focus
Catch up on our recent coverage of Advamed’s The Medtech Conference.
By Elise Reuter • Oct. 23, 2024 -
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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 -
Courtesy of Hologic
Hologic to lay off 86 people in closure of Connecticut facility
The company committed to closing the facility, which makes breast health products, in late 2021 and gave most employees the option to relocate to other sites.
By Nick Paul Taylor • Oct. 23, 2024 -
Courtesy of Boston Scientific
Boston Scientific boosts PFA expectations, citing rapid Farapulse adoption
Demand for the pulsed field ablation device drove the company’s electrophysiology sales up 177% in the third quarter compared to a year ago.
By Susan Kelly • Oct. 23, 2024 -
Retrieved from iRhythm on October 22, 2024
iRhythm’s Zio AT design changes win FDA clearance
The agency cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.
By Susan Kelly • Oct. 23, 2024 -
Elise Reuter/MedTech Dive
Tarver named new director of FDA’s device center
Michelle Tarver, who will officially replace longtime CDRH leader Jeff Shuren, emphasized the agency’s focus on patients in comments last week.
By Elise Reuter • Oct. 22, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceThat’s a wrap: 5 takeaways from The Medtech Conference
The conference — Advamed’s largest — featured an appearance by the device center’s new acting director and sessions on AI, clinical trial diversity and the FDA’s contentious LDT rule.
By Elise Reuter • Oct. 22, 2024 -
Courtesy of Boston Scientific
Boston Scientific, Edwards and Dexcom usher in second week of earnings
Johnson & Johnson, Abbott and Intuitive Surgical made a mixed start to earnings season last week.
By Nick Paul Taylor • Oct. 22, 2024 -
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 -
Elise Reuter/MedTech Dive
The Medtech Conference
Tarver, 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
