Medical Devices: Page 5
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FDA guidance eases wearables oversight. But experts have questions about what’s next.
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
By Elise Reuter • Jan. 27, 2026 -
Medtronic wins CE mark for single-shot pulsed field ablation catheter
Medtronic’s Affera Sphere-360 is a single-shot device, putting it in direct competition with Boston Scientific’s Farawave catheter.
By Nick Paul Taylor • Jan. 26, 2026 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Intuitive’s cardiac initiative includes valve repair, LAA closure
With nine new procedures cleared for the da Vinci 5 robot, Intuitive’s strategy includes working with a limited number of U.S. sites this year to establish cardiac programs.
By Susan Kelly • Jan. 26, 2026 -
Intuitive pushes into cardiac robotic surgery, ASCs
The robotics giant revealed on an earnings call that it won FDA clearance for several cardiac procedures and is also ramping up its presence in ambulatory surgery centers.
By Susan Kelly • Jan. 23, 2026 -
Integra recalls wound and burn devices amid reports of serious injuries
Packaging failures could lead to breaches in the sterile barrier and patient infections.
By Nick Paul Taylor • Jan. 23, 2026 -
Abbott posts Q4 sales below expectations
Pricing challenges in Abbott’s nutrition business and lower than expected sales of continuous glucose monitors drove down the company’s shares.
By Elise Reuter • Jan. 22, 2026 -
AdvaMed leaders on tariffs, MDUFA and wearables
AdvaMed CEO Scott Whitaker and Mick Farrell, new board chair of the trade group, weighed in on important issues for the medtech industry one year into the Trump administration.
By Elise Reuter • Jan. 22, 2026 -
J&J’s cardiovascular business boosts medtech growth in 2025
Cardiovascular was the only business unit to grow by double digits last year, helping to fuel the overall medical device business to top $33 billion.
By Ricky Zipp • Jan. 21, 2026 -
Retrieved from Anteris Technologies Global on January 21, 2026
Medtronic to buy up to $90M stake in heart valve developer Anteris
Medtronic’s investment is contingent on Anteris completing a proposed $200 million public stock offering.
By Susan Kelly • Jan. 21, 2026 -
BVI appoints Jim Hollingshead as CEO
Hollingshead, the former CEO of Insulet, will lead BVI as it uses a $1 billion financing to support its global eye care business.
By Nick Paul Taylor • Jan. 21, 2026 -
Abbott gets Europe’s CE mark for dual ablation catheter
The device can deliver both radiofrequency energy and pulsed field ablation to treat heart arrhythmias.
By Elise Reuter • Jan. 20, 2026 -
3 takeaways from Boston Scientific’s $14.5B Penumbra deal
Penumbra is expected to give Boston Scientific more of a presence in the vascular surgery market, with little overlap between the two companies’ products.
By Elise Reuter • Jan. 20, 2026 -
Boston Scientific recalls stent over issue linked to 3 deaths
The company said the deaths were associated with off-label or investigational use of the device.
By Nick Paul Taylor • Jan. 20, 2026 -
Intuitive says general surgery, acute care fuel US robot momentum
CEO Dave Rosa said a strong rollout for the da Vinci 5 surgical robot in 2025 exceeded expectations, with the system driving greater utilization than the earlier Xi model.
By Susan Kelly • Jan. 16, 2026 -
STAAR CEO exits after company rejects Alcon buyout
An activist investor has reshaped the board, securing the departures of STAAR’s CEO and chair.
By Nick Paul Taylor • Jan. 16, 2026 -
Trump issues 25% tariffs on narrow range of semiconductors
The levies, effective Jan. 15, do not cover products used for data centers and consumer applications, per a proclamation signed Wednesday.
By Antone Gonsalves , Phil Neuffer • Jan. 15, 2026 -
Boston Scientific to acquire Penumbra for $14.5B
With the planned purchase, Boston Scientific will gain several thrombectomy devices to remove clots from blood vessels.
By Elise Reuter • Jan. 15, 2026 -
Medtronic inks deal to build brain computer interface into surgical system
Medtronic will integrate Precision Neuroscience’s Layer 7 cortical interface with its StealthStation surgical navigation system.
By Nick Paul Taylor • Jan. 15, 2026 -
Deep Dive
5 topics to watch as MDUFA negotiations restart
The next Medical Device User Fee Amendments, which will set how much the FDA can raise from the industry in fees over a five-year period, are expected to go to Congress this year.
By Elise Reuter • Jan. 14, 2026 -
Boston Scientific gains FDA’s OK for new PFA catheter
The Farapoint device adds another tool to the company’s pulsed field ablation portfolio that could help increase or sustain its electrophysiology market share, one analyst said.
By Susan Kelly • Jan. 14, 2026 -
Smith & Nephew to acquire Integrity Orthopaedics for up to $450M
The company has committed the cash, half of which it is paying upfront, to buy Integrity Orthopaedics for its rotator cuff repair system.
By Nick Paul Taylor • Jan. 14, 2026 -
Medtronic gets FDA clearance for smart insulin pen app
The app pairs Medtronic’s smart insulin pens with a sensor made by Abbott.
By Elise Reuter • Jan. 13, 2026 -
Inspire appoints Matt Osberg as CFO
While Osberg joins Inspire without prior medtech experience, CEO Tim Herbert says the new CFO can help take the company “to the next level.”
By Nick Paul Taylor • Jan. 13, 2026 -
Boston Scientific to buy incontinence device maker Valencia
The deal would set up Boston Scientific to compete with Medtronic in the market for neuromodulation devices that work by stimulating the tibial nerve.
By Susan Kelly • Jan. 12, 2026 -
Edwards calls off JenaValve buyout after court halts deal
Edwards terminated the deal after the Federal Trade Commission moved to block the acquisition due to anticompetitive concerns.
By Susan Kelly • Jan. 12, 2026