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BioWorld - Sunday, February 15, 2026
Home » Topics » U.S., Medical technology

U.S., Medical technology
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Boston Scientific Farapulse PFS system

Boston Sci’s Farapulse better than thermal ablation at 4 years

Feb. 11, 2026
By Shani Alexander
No Comments
Boston Scientific Corp. recently reported new four-year data on its Farapulse pulsed field ablation platform, which demonstrated that patients with paroxysmal atrial fibrillation achieved better long-term success than those treated with thermal ablation. The data come as sales of the Farapulse system in the U.S. have begun to slow amid rising competition from other PFA technologies, particularly Medtronic plc’s Affera platform.
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Global investors optimistic about med-tech exits in 2026

Feb. 9, 2026
By Shani Alexander
No Comments
Global investors in med tech are confident about exit opportunities in the year ahead. The strategics have already started making acquisitions, the IPO window – which reopened last year – is expected to remain active, and the investment firms have companies in their portfolios that are well-positioned for exit. With fundamentals in the sector still robust, 2026 is expected to reward companies that deliver clear clinical value.
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Medtronic to pay Applied Medical $382M in antitrust ruling

Feb. 6, 2026
By Shani Alexander
No Comments
A jury in a U.S. District Court unanimously found that Medtronic plc violated federal and state antitrust laws relating to its blood sealing surgical devices and must pay $382 million in damages to Applied Medical Resources Corp.
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Paragonix KidneyVault

Paragonix’s Kidneyvault extends kidney preservation to 29 hours

Feb. 6, 2026
By Shani Alexander
No Comments
Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system managed to preserve and enable the reallocation of a donor kidney for more than 29 hours, despite prolonged ischemic time, multiple handoffs and two commercial flights. Throughout the period, the Kidneyvault maintained stable hypothermic preservation, preventing the organ from being discarded and allowing it to be transplanted into a patient.
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Boston Sci sees shares tumble despite strong Q4 results

Feb. 4, 2026
By Shani Alexander
No Comments
Despite reporting strong fourth-quarter (Q4) organic sales growth of $5.29 billion, up 12.7% year-on-year, Boston Scientific Corp. saw its shares plunge more than 17% in early trading. Investors appeared disappointed by weaker U.S. sales in the electrophysiology and Watchman businesses, two of the company’s growth engines, and concern over the 2026 organic growth guidance provided by management of 10% to 11%, down from the 15.8% seen in 2025.
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FDA updates cybersecurity guidance for medical devices

Feb. 4, 2026
No Comments
The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.
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Cathworks Ffrangio system

Medtronic to acquire Cathworks for $585M

Feb. 3, 2026
By Shani Alexander
No Comments
Medtronic plc is continuing to put its money where its mouth is as it plans to exercise its option to acquire Cathworks Ltd. for up to $585 million. The company said last month it was committed to expanding its pipeline through strategic investments and targeted acquisitions. The move for Cathworks comes on the heels of Medtronic’s $90 million investment in Anteris Technologies Global Corp.
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Jada device image

Laborie acquires Jada from Organon in $465M deal

Jan. 30, 2026
By Annette Boyle
Laborie Medical Technologies Corp. secured a new gem for its maternal health with the acquisition of the Jada system from Organon & Co. The terms of the deal, first announced in November, included payment of $440 million at closing, with an additional $25 million tied to 2026 revenue targets.
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Medicare puzzle

CMS rewrites organ procurement rule to expand availability

Jan. 30, 2026
By Mark McCarty
A new draft guidance for organ procurement organizations doing business in the U.S. would seem to tackle some pressing issues with organ donation, such as the conditions in which a problem qualifies as an adverse event. Perhaps of greater interest to companies in the organ container business is that the Centers for Medicare & Medicaid Services is intent on increasing the availability of organ donations to deal with an insatiable demand for donated organs.
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En Carta EC Pocket Lyme test

En Carta Lyme disease test wins FDA breakthrough designation

Jan. 29, 2026
By Shani Alexander
En Carta Diagnostics SA's EC Pocket Lyme received FDA breakthrough device designation for its rapid, molecular diagnostic test for the early detection of Borrelia bacteria, which causes Lyme disease. The designation marks a pivotal step for the French startup as it will enable closer interaction with the agency, accelerating its route to market, and getting it to patients sooner.
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