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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

PMA

Haemonetics wins FDA approval for a patch that seals 26F arteriotomies

MedDevice Startups Staff · 2 days ago · 2 min read · Via Haemonetics

FDA approved the Haemonetics PerQseal Elite vascular closure system on October 19. The device closes the access site after procedures that use 14F to 22F sheaths. Its bioabsorbable patch seals arteriotomies up to 26F, placed from inside the vessel, and leaves nothing permanent behind.

The approval lands nine months after Haemonetics bought Vivasure Medical for $116.4 million in January 2026. PerQseal Elite has carried a CE mark in Europe since 2025, for arterial and venous use. In the single-arm, multicenter ELITE arterial study, Haemonetics reported no major complications by VARC-3 criteria through 30 days. Mean time to hemostasis was under one minute.

Buying a CE-marked device and then running the US approval in house is a familiar structure, and the European file rarely carries the whole load. Haemonetics says it will present the ELITE data at TCT at the end of October. It has not given a US launch date.

Questions & Answers

What did Haemonetics get FDA approval for in October 2026?

FDA approved the Haemonetics PerQseal Elite vascular closure system on October 19, 2026, for large-bore arterial access. It closes sites created with 14F to 22F sheaths.

What sheath sizes does the Haemonetics PerQseal Elite close?

PerQseal Elite covers procedures using 14F to 22F sheaths. Its bioabsorbable patch seals arteriotomies up to 26F, placed from inside the vessel.

How did Haemonetics acquire PerQseal Elite?

Haemonetics bought Vivasure Medical for $116.4 million in January 2026, and PerQseal Elite came with that deal. The device had already held a CE mark in Europe since 2025.

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