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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
The Directory // Ophthalmology & ENT

Ophthalmology & ENT

Eye, ear, nose and throat devices and implants. 8 companies listed.

Los Angeles, CA  ·  Est. 2016  ·  Unknown

Develops stimulus responsive materials for biomedical use. Its lead product, Humidifeye, is a thermally responsive treatment for dry eye disease.

Suzhou, China  ·  Series B  ·  Not a regulated device

Develops ophthalmic imaging hardware and AI diagnostic software, including the MIAS-3000 OCT analysis system cleared as a Class III device in China.

Brooklyn, NY  ·  Est. 2018  ·  Unknown  ·  Not a regulated device

Virtual reality platform for eye exams, covering visual fields, pupillometry, ocular motility, contrast sensitivity and color vision, with EMR integration for clinics.

West Fargo, ND  ·  Unknown  ·  Not a regulated device

Makes InSightVR, a virtual reality tool that uses a cataract patient's own biometry to simulate vision with different intraocular lenses before surgery. Carrot agreed to acquire the company in October 2026.

Boston, MA  ·  Est. 2024  ·  Seed  ·  $12M raised

Builds hearing assistance into eyeglass frames, sold over the counter. Founded by engineers from Bose and Apple.

Est. 2021  ·  Series C  ·  $490M raised  ·  Submission pending

Develops the PRIMA retinal implant, a photovoltaic chip that acts as artificial photoreceptors to restore central vision lost to geographic atrophy.

Bristol, United Kingdom  ·  Est. 2020  ·  Seed  ·  £470K equity plus an £8.4M Innovate UK contract raised  ·  In development

Builds handheld optical coherence tomography systems on a photonic chip, for retinal disease monitoring in clinics and at home.

Reno, NV  ·  Unknown  ·  In development

Develops the Z+ Virtual Aperture intraocular lens, which uses a 2.8mm central optic inside a virtual aperture zone to reshape light rather than split it across focal points. The lens is investigational and sold nowhere yet.

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