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THE TAPE

FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US

Restructuring

Adagio Medical cuts 25 of 43 employees and opens a strategic review with $7.7M in the bank

MedDevice Startups Staff · 2 days ago · 2 min read · Via Fierce Biotech

Adagio Medical cut 25 of its 43 full-time employees and opened a strategic review on September 23. Severance is expected to run about $1.3M.

The board is exploring an acquisition, merger, business combination or other transaction, and has set no timetable. Adagio held $7.7M in cash, cash equivalents and marketable securities as of June 30. Nasdaq notified the company in August that it had fallen below the $2.5M minimum stockholders equity requirement.

The vCLAS ventricular ablation system carries a CE mark, and FULCRUM-VT results went to FDA in May to support the PMA. Adagio paused its limited European launch in early 2025 to work on product design. Shares fell 53 percent to close at 23 cents against a 52-week high of $2.58. A PMA already under review is an asset a buyer can price, which is part of why this review is running now rather than after a decision.

Questions & Answers

How many employees did Adagio Medical lay off?

Adagio Medical cut 25 of its 43 full-time employees, announced September 23, 2026, with about $1.3M in expected severance costs.

What is the status of the Adagio Medical vCLAS PMA?

Adagio Medical submitted FULCRUM-VT results to FDA in May 2026 to support the premarket approval application for the vCLAS ventricular ablation system. The system already carries a CE mark in Europe, though Adagio paused its limited European launch in early 2025.

How much cash does Adagio Medical have?

Adagio Medical reported $7.7M in cash, cash equivalents and marketable securities as of June 30, 2026. Nasdaq notified the company in August 2026 that it had fallen below the $2.5M minimum stockholders equity requirement.

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