FDA Clears Resitu Medical’s Breast Biopsy Device

Resitu Medical has received U.S. Food and Drug Administration 510(k) clearance for its RESL09 device, which is used to obtain breast tissue for analyzing imaged abnormalities. 

RESL09 is a handheld, minimally invasive, vacuum assisted, single-use device capable of excising large breast tissue samples, with a diameter up to 9mm for diagnostic purposes. The device is guided by ultrasound, and the surgeon introduces the device through a small incision in the breast. The device is advanced through the tissue with blunt dissection, until the instrument tip is in front of the lesion. The sample capture relies on a combination of vacuum fixation followed by cutting with a circular knife. To excise the sample, the device uses an electrosurgical cutting electrode. The instrument—with the sample inside the tube—is then withdrawn and the lesion is sent for histopathological analysis.  

“For any medical device company, obtaining 510(k) authorization is a significant milestone. We submitted our application in July and are encouraged to receive the clearance today,” Resitu CEO Åsa Runnäs said. “This marks the starting point of being able to provide surgeons with a much-needed tool for large tissue biopsy harvestings for diagnostic purpose. The U.S., being the world’s largest medtech market, has since the beginning been a key strategic focus for Resitu.” 

In collaboration with its distributors, Resitu is pursuing a limited launch for RESL09 in select geographies in the United States, Europe (post CE mark), and the United Arab Emirates (post approval and registration). After than, Resitu will continue with regulatory submissions and an eventual global launch of the RESL device. The company also will continue developing and studying new products based on the Resitu platform technology. 

“I am immensely proud of how far Resitu has come in such a short time. Having worked in the oncoplastic space for several decades, I am assured by surgeons on a global basis that they have been waiting for a system like ours for a very longe time,” Resitu Founder/RESL09 system inventor Dr. Per Hedén concluded.

Resitu Medical is a Swedish company that develops instruments for removing large breast tissue samples. The company was founded in 2019 to develop and commercialize a technology developed by one of Europe’s most famous plastic surgeons, Dr. Hedén. Resitu has progressed through development stages and is about to launch its first device for obtaining breast tissue for further analysis. The company first is targeting the European (pending CE mark) and U.S. markets, where it has the support of key clinicians throughout the Nordics, United Kingdom, Germany, Switzerland and United States. After approval and registration, the product will be released in the Middle East and selected African countries.