The Latest
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.”
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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.
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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.
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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.
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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.
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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.
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FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs
Cue Health began the recall of nearly 250,000 COVID-19 test kits in May, shortly after the FDA advised people at home and healthcare professionals not to use the products.
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The Medtech Conference
FDA, 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.
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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.