Claria Medical Secures FDA De Novo Clearance for Hysterectomy Tissue Extraction System

The Claria System is designed to improve safety and efficiency during minimally invasive hysterectomy procedures by providing a controlled tissue extraction approach.

Claria Medical has received FDA De Novo classification and marketing authorisation for its Claria System, a medical device designed to support tissue extraction during minimally invasive hysterectomy procedures.

The approval allows Claria Medical to introduce a new device category for its uterine containment and extraction technology, which aims to improve procedural safety while reducing challenges associated with current approaches to tissue removal.

The FDA reviewed the device through its Safer Technologies Program (STeP), an initiative designed to accelerate regulatory review for medical technologies that demonstrate potential safety improvements compared with existing treatment options.

Claria System Designed to Improve Hysterectomy Safety

Hysterectomy is one of the most commonly performed gynaecological surgical procedures, with minimally invasive approaches increasingly used to reduce recovery times and improve patient outcomes.

However, tissue extraction during these procedures remains a key technical challenge, particularly when removing larger uteri.

The Claria System has been developed as a uterine containment and extraction solution designed to support surgeons during minimally invasive hysterectomy procedures.

The device uses SafeStop technology, which combines electronic communication between a tri-layer tissue container and handpiece to help monitor the system and reduce the risk of unintended breaches of the containment barrier.

According to Claria Medical, the system enables a transvaginal tissue extraction approach, potentially avoiding the need for mini-laparotomy procedures.

The company said the device also features an ergonomic design intended to improve usability for surgeons during procedures.

Clinical Study Supported FDA Submission

The FDA authorisation was supported by data from a multinational, prospective, controlled clinical study evaluating the safety and performance of the Claria System.

The study reported positive outcomes, including a median extraction time of four minutes for large uteri.

Claria Medical said surgeons participating in the trial achieved these results following minimal device training, with all participating surgeons providing favourable feedback on the technology.

The company is expected to present more detailed clinical findings later this year.

FDA Clearance Through Safer Technologies Program

The Claria System was reviewed through the FDA’s Safer Technologies Program, which provides an alternative regulatory pathway for devices that may offer significant improvements in safety compared with existing technologies.

The De Novo pathway is used for novel medical devices where no existing classification applies but where the FDA determines the technology presents low to moderate risk.

Following authorisation, Claria Medical plans to establish commercial pilot sites with leading US healthcare systems.

The company said the next phase will focus on introducing the technology to hospitals, surgeons and patients across the country.

Addressing an Unmet Need in Minimally Invasive Surgery

Claria Medical CEO Alexey Salamini said current approaches to tissue extraction present safety challenges and that the company’s goal is to provide surgeons with a safer alternative.

The company believes the Claria System could help improve procedural workflows while addressing concerns associated with tissue containment during minimally invasive hysterectomy.

The technology is backed by private and strategic investors and has also received grant support from the National Institutes of Health (NIH) and the National Science Foundation (NSF).

The Future of Surgical Technology Innovation

The FDA clearance highlights continued innovation in minimally invasive surgical technologies, with companies increasingly focused on improving safety, reducing procedural complexity and supporting better patient outcomes.

As healthcare systems continue to prioritise less invasive procedures, technologies that improve surgical efficiency while addressing safety concerns are becoming an important area of medical device development.

The Claria System’s entry into the US market represents another example of how targeted device innovation is reshaping established surgical workflows.

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