The technology enables radiologists to mark lesions rapidly and precisely

FDA device

The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

MOLLI Surgical has secured approval from the US Food and Drug Administration (FDA) for its new wire-free localisation technology for breast cancer surgery.

The technology allows radiologists to mark lesions rapidly and precisely, as well as helps surgeons to efficiently locate and remove lesions.

MOLLI Surgical’s new platform includes an implantable marker, detection wand and visualisation tablet, which help in better tumour localisation.

MOLLI Surgical CEO Fazila Seker said: “This year, alone, more than two million women around the globe will receive the devastating news that they have breast cancer.

“Our mission is to make their journey smoother and support them along the way. Our new MOLLI technology will make breast cancer surgery easier and more precise as it helps healthcare providers locate and remove even the smallest tumors with unprecedented precision.”

According to the company, the technology is designed for use by both radiologists and surgeons and delivers efficient clinical workflows compared to wire or radioactive seed methods.

A non-radioactive and solid magnet technology is used by the MOLLI for the marking of target tissue on the same day or within 30 days prior to surgery.

During the surgical procedure, the surgeon has to use the MOLLI Wand to detect the MOLLI Marker and remove the lesion.

With only 3.2mm in size, the MOLLI Marker enables radiologists to precisely localise the smallest non-palpable tumours.

MOLLI also stated that the new technology uses the benefits of easy introducer needle insertion and standard marker deployment and is compatible with conventional mammography and ultrasound imaging.