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Boston Scientific Gets FDA’s 510(k) Clearance for EXALT Bronchoscope

August 13, 2021

Boston Scientific has received 510(k) clearance from the FDA for its EXALT Model B single-use bronchoscope.

The EXALT Model B, which includes suction and imaging functions, can be used for procedures such as secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal tube placement and biopsies.

The Marlborough, Mass.-based company says the device is designed for use in bedside procedures in the intensive care unit and in the operating room. The company received a CE mark for the bronchoscope in May.

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