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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

Private round

Curadel Surgical Innovations reports $49.8M sold in a $57.5M private round

MedDevice Startups Staff · Oct 13 · 2 min read · Via SEC Form D filing

Curadel Surgical Innovations told the SEC it has sold $49,844,295 of a $57.5 million offering, leaving $7,655,705 open. The Form D is signed October 13 and lists 39 investors, with the date of first sale set at September 18, 2026.

The filing names John V. Frangioni as chief executive and director, with Garen Bohlin, Marc V. Garnick, Sean Stalfort and Walid Fakhry on the board. The company lists an address in Bonita Springs, Florida, and filed under the health care and biotechnology industry group.

Curadel's flagship product is ZW800-1, a fluorescence contrast agent for image-guided surgery that the company said in 2021 it was moving toward commercialization. A contrast agent travels the drug pathway, not a 510(k), so money at this size goes to trial work and manufacturing controls rather than to a device submission.

Questions & Answers

How much has Curadel Surgical Innovations raised in its current round?

Curadel Surgical Innovations reported selling $49,844,295 of a $57.5 million offering in a Form D signed October 13, 2026, leaving about $7.66 million open. Thirty-nine investors had participated as of the filing.

When did Curadel Surgical Innovations start selling securities in this round?

The Form D lists the date of first sale as September 18, 2026. The filing covers an equity offering and was made under the health care and biotechnology industry group.

What does Curadel Surgical Innovations develop?

Curadel Surgical Innovations is behind ZW800-1, a fluorescence contrast agent for image-guided surgery that the company said in 2021 it was moving toward commercialization. The Form D lists an address in Bonita Springs, Florida, with John V. Frangioni as chief executive.

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