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Pristine Surgical received FDA 510(k) clearance to market Summit, a first-of-its-kind 4K single-use surgical arthroscope designed to improve the efficiency, consistency and safety of arthroscopic procedures.
Pristine Surgical expects to launch Summit within 1Q23 with a transparent subscription pricing model and an automated re-ordering system.
Summit combines a 4K single-use surgical arthroscope with Pristine Connect™ cloud-based software to deliver a high-definition image. The scope is simple to set up and 100% sterile, ensuring patient and staff safety.
Pristine Surgical developed the Summit single-use arthroscope to address challenges with conventional surgical visualization systems, which can be complex and expensive, and feature reusable arthroscopes that are costly to maintain.
Factors such as the costly, cumbersome nature of legacy arthroscopes and the risk of contamination and infection led Pristine Surgical to develop single-use rigid endoscopes.
“Summit simplifies arthroscopic procedures, offering a fully integrated single-use scope with 4K resolution that’s one-of-a-kind,” said Bryan Lord, CEO of Pristine Surgical. “Our FDA clearance is a significant milestone for the company. More importantly, it means that we can now begin offering the benefits of these single-use devices to surgeons and staff, and bring our single-use, cloud-based platform to more than 125 million endoscopy patients treated worldwide each year.”
Source: Pristine Surgical
