Medical Devices: Page 11
-
Edwards data show benefit of early TAVR over ‘watchful waiting’
Study author Philippe Genereux said the trial data “shatter 60 years of ingrained belief on the treatment for severe aortic stenosis.”
By Susan Kelly • Oct. 29, 2024 -
Courtesy of Abiomed
J&J to seek FDA approval after small-bore Impella heart pump hits trial goal
The company has predicted the narrower Impella ECP will be easier to insert and implant, as well as enable the use of small bore access and closure techniques.
By Nick Paul Taylor • Oct. 29, 2024 -
Explore the Trendline➔
Sitthiphong via Getty Images
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 -
Courtesy of Boston Scientific
Boston Scientific to close Silk Road Medical headquarters, lay off 138 people
Following its acquisition of Silk Road in September, Boston Scientific said it plans to consolidate the company’s work in Minnesota.
By Elise Reuter • Oct. 28, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips cuts sales forecast after ‘significant deterioration’ in China
CEO Roy Jakobs expects the slump to continue into 2025, driven by China’s anti-corruption measures.
By Nick Paul Taylor • Oct. 28, 2024 -
Retrieved from Hologic on May 23, 2024
FDA advises clinicians to stop using Hologic radiographic markers
Hologic has recalled the Biozorb devices after 188 reports of adverse events in patients who received the implants in breast tissue.
By Susan Kelly • Oct. 28, 2024 -
Permission granted by Dexcom
Dexcom chief commercial officer to retire
Teri Lawver is leaving the diabetes tech company during a challenging time, with sales slowing after a workforce restructuring.
By Elise Reuter • Oct. 25, 2024 -
Courtesy of Edwards Lifesciences
Edwards’ TAVR sales faced ongoing hospital constraints in Q3
Hurt by a slowdown in procedures for its heart valve replacement devices, Edwards said it is working with hospitals to manage workflow challenges.
By Susan Kelly • Oct. 25, 2024 -
Bevan Goldswain via Getty Images
Baxter to restart high-throughput IV solutions manufacturing line
Baxter still does not have a timeline for fully restoring production at the North Carolina facility, which was hit by Hurricane Helene.
By Elise Reuter • Oct. 25, 2024 -
Courtesy of Medtronic
Medtronic wins FDA approval for Affera mapping and ablation system
Affera combines mapping technology with a catheter capable of performing radiofrequency and pulsed field ablation.
By Nick Paul Taylor • Oct. 25, 2024 -
Carl Court via Getty Images
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
The Medtech ConferenceMedtech 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 -
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 on Oct. 17.
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
Previous
