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Boston Scientific says plants and shipping are fully back 17 days after the cyberattack ARPA-H commits $62.7M to autonomous heart failure AI and wants FDA packages in two years Glucotrack raises $11.5M in convertible notes at a 22 percent original issue discount Cardiovascular AI notification software gets its own Class II regulation and a 510(k) path CMS covers TAVR for asymptomatic patients and drops the evidence requirement for symptomatic ones FDA codifies eight De Novo device types as Class II, three years after granting them Axogen to pay $200M cash for BioCircuit and its sutureless NerveTape Nutromics wins Breakthrough designation for a microneedle patch that reads vancomycin levels Precera Medical buys Additive Metal Services to bring metal injection molding in house Boston Scientific says plants and shipping are fully back 17 days after the cyberattack ARPA-H commits $62.7M to autonomous heart failure AI and wants FDA packages in two years Glucotrack raises $11.5M in convertible notes at a 22 percent original issue discount Cardiovascular AI notification software gets its own Class II regulation and a 510(k) path CMS covers TAVR for asymptomatic patients and drops the evidence requirement for symptomatic ones FDA codifies eight De Novo device types as Class II, three years after granting them Axogen to pay $200M cash for BioCircuit and its sutureless NerveTape Nutromics wins Breakthrough designation for a microneedle patch that reads vancomycin levels Precera Medical buys Additive Metal Services to bring metal injection molding in house

CE mark

Bausch + Lomb wins a CE mark for the SeeLyra femtosecond laser

MedDevice Startups Staff · 3 days ago · 2 min read · Via Business Wire

Bausch + Lomb said on September 10 that SeeLyra, its next femtosecond laser platform, carries a CE mark. Europe gets it for premium cataract surgery, LASIK flap creation and corneal therapeutic procedures. Live swept source OCT gives the surgeon depth imaging during the cut.

The design drops the fixed patient bed, so SeeLyra works with the beds already in the room and mounts on an articulating swing arm. That matters in a surgery center running cataract cases back to back with no bay to spare. The interface carries over from the VICTUS platform it follows. Limited European availability starts in the coming months, with broader release set for 2027. Bausch + Lomb says it is still seeking approval in the United States and has not named a date.

Questions & Answers

What is the Bausch + Lomb SeeLyra femtosecond laser?

SeeLyra is Bausch + Lomb's femtosecond laser platform for premium cataract surgery, LASIK flap creation and corneal therapeutic surgery. It uses live swept source OCT for depth visualization and received a European CE mark announced September 10, 2026.

Is the Bausch + Lomb SeeLyra laser FDA cleared?

No. As of the September 10, 2026 CE mark announcement, Bausch + Lomb said it is still seeking regulatory approval for SeeLyra in the United States and other markets, with no timing given.

When will SeeLyra be available in Europe?

Bausch + Lomb said limited European availability begins in the months after the September 10, 2026 CE mark, with broader availability expected in 2027.

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