The Latest

• 

  Thoughtful implementation, ongoing monitoring key to safe health AI

  Healthcare organizations will need to test models in their local environments, keep an eye on performance and work together to implement the technology, panelists said at HLTH.

  AI

• 

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  Health startups need consolidation after pandemic funding ‘sugar high’

  M&A could allow startups to add products and capabilities in a more restrained funding environment, panelists said at HLTH.

  Digital Health

• 

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  The Medtech Conference

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  The Medtech Conference

  That’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.

  Clinical Trials

• 

  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.

  Medical Devices

• 

  GE Healthcare opens AI Innovation Lab to grow new projects

  The AI Innovation Lab is designed to accelerate early concept artificial intelligence projects including tools to predict the recurrence of cancer and automate image interpretation.

  Digital Health

• 

  Deep Dive

  5 steps to navigate the FDA’s new lab developed test rule

  Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.

  FDA

• 

  Boston Scientific wins FDA approval for Farapulse cardiac mapping

  Stifel analyst Rick Wise said Boston Scientific can now offer “one-stop-shopping” with a pulsed field ablation catheter and integrated mapping system to treat atrial fibrillation.

  FDA

• 

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  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.”

  Medical Devices

• 

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  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.

  Medical Devices

• 

  The Medtech Conference

  Legacy 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.

  Medical Devices

• 

  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.

  Medical Devices

More stories