US-based medical technology manufacturer Pristine Surgical has received the US Food and Drug Administration (FDA) approval for its 4K single-use surgical arthroscope, Summit.
Summit combines a 4K single-use surgical arthroscope with cloud-based software, dubbed Pristine Connect, to deliver a high-definition image, with a new device every time.
The simple-to-set-up scope is 100% sterile, ensuring patient and staff safety, and its automated inventory management improves predictability and workflow, said the company.
Pristine Surgical chief medical officer and arthroscopy specialist Stephen Snyder said: “The Summit single-use arthroscope represents a new paradigm in arthroscopy, improving a procedure that hasn’t changed much in my 42 years of practice and beyond.
“We’re removing the well-known barriers of legacy, reusable systems that eventually become obsolete by offering a new 4K single-use scope that improves safety and reliability while decreasing room turnover time and the cost of arthroscopic treatment.”
Summit single-use arthroscope has been developed to address challenges related to conventional surgical visualisation, which is complex and expensive.
The reusable arthroscopes are costly to maintain, prone to wear, damage, and potential infection, and may result in operating room inefficiency, said the company.
Pristine intends to roll out the Summit single-use arthroscope during the first quarter of 2023.
The company is planning to offer the product through a predictable and transparent subscription pricing model and an automated re-ordering system.
In addition, it aims to provide recycling options through sustainability partnerships.
Pristine Surgical CEO Bryan Lord said: “Summit simplifies arthroscopic procedures, offering a fully integrated single-use scope with 4K resolution that’s one-of-a-kind.
“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.”
