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Zdrowie i gospodarka · 10/09/2026

FDA Classifies Cooperative Powered Surgical Assist Device for ENT Surgery into Class II

The FDA has classified the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery into Class II, a designation that will ensure the device's safety and effectiveness, while also reducing regulatory burdens and increasing access to innovative devices.

Source: Federal Register — Health and Human ServicesOpen original release →