Boston Scientific's Exalt Model B Single-Use Bronchoscope Wins FDA Approval

The FDA has given 510(k) clearance for Boston Scientific Corp's BSX Exalt Model B single-use bronchoscope for use in bedside procedures within the intensive care unit and operating room.
The device can be used for a wide range of bronchoscopy procedures, including secretion management, airway intubation, percutaneous tracheostomy, double-lumen endotracheal tube placement, and biopsies.
According to a news release, Boston Scientific offers the device in slim, regular, and large sizes.
Exalt Model B joins the portfolio alongside Exalt Model D single-use duodenoscope, the LithoVue digital flexible ureteroscope, the SpyGlass DS direct visualization system, and the SpyGlass Discover digital catheter.
Exalt Model B received CE mark approval in May, and Boston Scientific plans to begin the limited market release of the platform in the U.S. within the coming weeks.
Price Action: BSX shares closed down 2.65% at $42.65 on Tuesday.
Related content: Benzinga's Full FDA Calendar.