Swedish medical device company Resitu Medical has received 510(k) marketing authorization from the US Food and Drug Administration (FDA) for its RESL09 breast biopsy device.
Resitu is planning a phased global rollout. The first use of the RESL09 in clinical practice is expected before the end of the year.
Following this US FDA clearance, the company, in collaboration with distributors, is pursuing a limited launch in select US geographies. Similar limited launches are planned for Europe, pending CE mark approval, and the United Arab Emirates, pending local registration.
How does the device work?
The RESL09 is a handheld, single-use device designed for the minimally invasive removal of large tissue samples from the breast, with a diameter of up to 9mm. This capability is crucial for the diagnostic analysis of imaged abnormalities, potentially offering a more definitive sample for pathologists compared to standard core needle biopsies.
The device utilizes a vacuum-assisted technique to fixate the tissue before a circular knife and an electrosurgical electrode excise the sample. Guided by ultrasound, surgeons can introduce the device through a small incision, minimizing patient trauma and scarring.
“This marks the starting point of being able to provide surgeons with a much-needed tool for large tissue biopsy harvestings for diagnostic purpose,” said Resitu CEO Åsa Runnäs. She highlighted the strategic importance of the US market and noted the company’s swift progress, having submitted the application as recently as July 2025.
The company noted the clinical value proposition of RESL09 is strong for both physicians and patients. For surgeons, it offers a precise, single-use instrument that can obtain substantial tissue samples in a single pass, which may improve diagnostic confidence. For patients, the minimally invasive approach promises a less painful procedure with a potentially quicker recovery and better cosmetic outcomes due to the smaller incision.
Resitu is moving forward with the regulatory submissions for the RESL device and expects to launch it globally. The company is also working on new devices and conducting clinical studies based on its Resitu platform technology.
