Claria Medical has won FDA De Novo clearance and marketing authorization for the Claria tissue-extraction system under the Safer Technologies Program (STeP). The system uses an electronic SafeStop containment interface to reduce breaches and enable transvaginal extraction without a mini-laparotomy. A multinational prospective trial reported positive safety and performance results, including a median extraction time of four minutes for large uteri and favorable surgeon feedback. The company plans US pilot sites and will publish full clinical data later this year.
Claria Medical Secures FDA De Novo Clearance and Marketing Authorization for Hysterectomy Tissue-Extraction System
The Claria system allows for transvaginal tissue extraction
Claria Medical has received De Novo classification and marketing authorization from the US Food and Drug Administration (FDA) for its Claria system, a device designed to support tissue extraction during minimally invasive hysterectomy procedures.
Device and Safety Technology
The Claria system integrates a uterine containment and extraction solution intended to improve the speed and safety of tissue removal. Central to the system is SafeStop, an electronic safeguard that links a tri-layer tissue container with a handpiece to monitor the integrity of the containment barrier and help prevent unintended breaches during extraction.
Clinical Evidence
The regulatory submission was supported by a multinational, prospective, controlled clinical study that reported positive safety and performance outcomes. In that trial, investigators recorded a median extraction time of four minutes for large uteri. Claria Medical stated that participating surgeons reached these results after minimal device training and provided favorable feedback on usability.
Regulatory Pathway and Next Steps
The FDA evaluated the Claria system through its Safer Technologies Program (STeP), which expedites assessment of technologies expected to provide safety advantages over current treatments. Following authorization, Claria Medical plans to establish commercial pilot sites with leading US health systems and will publish detailed clinical results later this year.
Claria Medical CEO Alexey Salamini 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 and helps us bring this technology to patients and surgeons across the country."
Claria Medical is backed by private and strategic investors and has received grant support from the National Institutes of Health (NIH) and the National Science Foundation (NSF).
Original reporting by Hospital Management, a GlobalData brand.
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