Boston Scientific has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its EXALT Model B single-use bronchoscope.

The company has designed the new bronchoscope for use in bedside procedures within the intensive care unit (ICU) and operating room (OR).

The EXALT Model B bronchoscope is suitable for use in a range of bronchoscopy procedures, including secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal tube placement and biopsies.

Boston Scientific is offering the new device in three sizes, including slim, regular and large. Each size will help deliver better suction performance and direct precise imaging.

Boston Scientific endoscopy president Dave Pierce said: “To further increase patient safety and improve operational efficiencies within the hospital setting, many physicians have been making the transition to single-use scopes, which eliminate both the risk of infection associated with reusable devices, as well as time-intensive scope reprocessing.

“Developed with physician needs and varying patient anatomies in mind, the EXALT Model B Bronchoscope was designed to bring a new level of suction and imaging performance to single-use scopes and offers a familiar design and feel to that of a reusable device.”

Boston Scientific is planning the limited market release of EXALT Model B bronchoscope in the US in the coming weeks.

In May this year, the company secured CE mark approval for its EXALT Model B bronchoscope.

According to the company, more than 1.2 million bedside procedures involving a bronchoscope are performed in ICU and OR settings each year across the US and over three million are performed across the world.

The FDA suggests health care providers to use a single-use bronchoscope in situations where there is increased risk of spreading infection or when there is no support available for immediate reprocessing of a reusable bronchoscope, said the company.

The EXALT Model B bronchoscope is the latest addition to Boston Scientific’s single-use imaging portfolio.

The company already offers EXALT Model D single-use duodenoscope, LithoVue digital flexible ureteroscope, SpyGlass DS direct visualisation system and SpyGlass discover digital catheter.