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TytoCare Secures FDA De Novo for First AI-Powered Eardrum Analysis

NEW YORK, April 27, 2026 /PRNewswire/ — TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced it has received FDA De Novo classification for the first model of Tyto Insights™ for ENT Suite, marking the creation of a new regulatory category for AI-powered ENT image analysis.

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CGBIO Receives FDA 510(k) Clearance for Patient-Specific Titanium Implant ‘EASYMADE TI’

SEOUL, South Korea, April 24, 2026 /PRNewswire/ — CGBIO (CEO: Hyunseung Yu) announced that its patient-specific titanium implant, EASYMADE TI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on April 9. The FDA 510(k) pathway is a premarket clearance process that demonstrates substantial equivalence to a legally marketed predicate device, allowing commercialization in the United States.

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