The Latest
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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.
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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.
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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.
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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.
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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.
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STAAR CEO exits after company rejects Alcon buyout
An activist investor has reshaped the board, securing the departures of STAAR’s CEO and chair.
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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.
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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.
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Trump unveils healthcare affordability plan
The “Great Healthcare Plan” is vague, but would send money directly to ACA enrollees and entrench Trump’s drug pricing deals.
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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.
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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.
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Digital health funding increases in 2025, spurred by AI: report
Startups raised $14.2 billion last year, the highest funding total since 2022. Health AI companies collected 54% of total funding, according to Rock Health.
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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.
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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.
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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.
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Medtronic gets FDA clearance for smart insulin pen app
The app pairs Medtronic’s smart insulin pens with a sensor made by Abbott.
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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.”
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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.
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Illumina names former NIH genomics director as chief medical officer
The company unveiled the appointment alongside news of the departure of its chief commercial officer.
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Haemonetics to acquire Vivasure Medical
The purchase is expected to expand Haemonetics’ impact in fast-growing markets for structural heart and endovascular procedures.
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Deep Dive
4 medtech topics to watch in 2026
From insurance coverage questions to M&A and tariffs, here are the top storylines to watch in the medical device space in 2026.
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Teleflex CEO leaving company
Stuart Randle, who retired in 2018, has replaced Liam Kelly as CEO and president on an interim basis.
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CMR robot earns CE mark in pediatrics; SS Innovations readies smaller instruments
CMR Surgical received the approval for abdominal surgery for its Versius platform in patients under age 18 in Europe, while SS Innovations will incorporate five new instruments into its SSi Mantra system.
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House votes to revive enhanced ACA subsidies
The House voted 230-196 to extend the financial assistance, which lapsed on Dec. 31, for three years. The measure is not expected to pass the Senate.
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FDA exempts more wearable, AI features from oversight
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.