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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

EU MDR

Butterfly Medical takes EU MDR certification for its prostate implant while its PMA sits at FDA

MedDevice Startups Staff · Oct 13 · 2 min read · Via PR Newswire (Butterfly Medical)

Butterfly Medical holds EU MDR certification for the Butterfly Prostatic Retraction Device, an implant for the urinary symptoms of benign prostatic hyperplasia. The company announced the CE mark October 13 from Boston and Yokneam, Israel. Certification followed a 244-patient trial.

The implant holds the prostatic lobes apart so urine flows, without ablating or cutting tissue, and a clinic needs no capital equipment to place it. Reported adverse events include bleeding, urinary discomfort, and increased frequency and urgency. Some implants require surgical removal.

A premarket approval application is with FDA, and the device is not approved for US sale. The PMA route rather than a 510(k) is the expensive decision in this file, and it means European revenue has to carry the company while the US submission moves. Butterfly announced a $21M upsized Series C in May 2026.

Questions & Answers

What did Butterfly Medical get certified in Europe?

Butterfly Medical received EU MDR certification for the Butterfly Prostatic Retraction Device, announced October 13, 2026. The implant treats urinary symptoms caused by benign prostatic hyperplasia without ablating prostate tissue.

Is the Butterfly Prostatic Retraction Device approved in the United States?

No. As of October 2026 Butterfly Medical has a premarket approval application with FDA for the Butterfly Prostatic Retraction Device, and the implant is not cleared or approved for commercial use in the US.

How much has Butterfly Medical raised?

Butterfly Medical announced a $21M upsized Series C in May 2026. The company operates out of Yokneam, Israel, with a Boston presence.

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