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April 12, 2021updated 25 Nov 2021 11:14am

FDA grants clearance to Activ Surgical’s intraoperative imaging module 

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Activ Surgical’s ActivSight Intraoperative Imaging Module for improved surgical visualisation.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Activ Surgical’s ActivSight Intraoperative Imaging Module for improved surgical visualisation.

The hardware agnostic imaging module can offer surgeons real-time intraoperative visual data and imaging which are currently not accessible to them via existing technologies. This will help provide better patient outcomes as well as improving safety in the operating room.

Activ Surgical CEO Todd Usen said: ‍“Receiving FDA 510(k) clearance for our ActivSight enhanced visualisation module is a significant milestone in bringing Activ Surgical’s technology to operating rooms around the world.

“Given there is a $36bn cost for preventable surgical errors, we believe ActivSight has the potential to make an immediate impact in the operating room (OR).

“We look forward to working closely with our initial pilot customers over the next several months to further validate ActivSight and revolutionise surgical care.”

The first available ActivInsight will be the Perfusion insights, which offers real-time viewing of blood flow and perfusion.

The initial launch of ActivSight is planned for the second half of this year.

In a separate development, the FDA has approved Cosmo Pharmaceuticals’ simple-to-use GI Genius intelligent endoscopy system for identifying lesions during colonoscopy.

This is the first device of its kind to get FDA approval through the De Novo application. It works in real-time, is compatible with all endoscopes and can aid endoscopists in identifying lesions.

‍Cosmo is the sole manufacturer of the device and Medtronic is exclusively in charge of global distribution.

Cosmo CEO Alessandro Della Chà said: “Through our global distribution partnership with Medtronic we are excited to pursue an opportunity which is worth at least $ 1.1bn, looking only at the opportunity for artificial intelligence in the colonoscopy market.”

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