Claria Medical has received De Novo classification and marketing authorisation from the US Food and Drug Administration (FDA) for its Claria System, a medical device designed to support tissue extraction during minimally invasive hysterectomy procedures.

The device was reviewed under the FDA's Safer Technologies Program (STeP), an initiative that expedites the evaluation of medical technologies expected to offer significant safety advantages over existing treatment options.

The Claria System incorporates a uterine containment and extraction system intended to improve the speed and safety of hysterectomy procedures for both surgeons and patients. 

A key feature of the device is its proprietary SafeStop technology, which uses electronic communication between a tri-layer tissue containment bag and the extraction handpiece to help detect and prevent unintended breaches of the safety barrier during tissue removal.

The system is designed to facilitate transvaginal tissue extraction, eliminating the need for a mini-laparotomy while offering an ergonomic design intended to simplify the procedure for surgeons.

The FDA submission was supported by a multinational, prospective, controlled clinical study demonstrating favourable safety and performance outcomes. According to the company, the trial reported a median extraction time of four minutes for large uteri, with surgeons achieving these results after minimal device training. Participating surgeons also provided positive feedback on the system's usability.

Detailed findings from the clinical study are expected to be presented later this year.

Alexey Salamini, Chief Executive Officer of Claria Medical, said, “The safety risks associated with today's standard of care are simply too high; women everywhere deserve a better, safer method for these vital surgical procedures.” 

“The FDA's authorisation as part of the STeP programme supports the Claria System's expected clinical benefit over currently available treatments and provides surgeons with a valuable new tool to address an urgent clinical need," he said.