FDA clears wireless localization technology for breast cancer surgery

In Clinical Studies News by Barbara Jacoby

From: healio.com

The FDA provided clearance for Molli, a wire-free localization technology that allows radiologists to mark lesions for removal during breast cancer surgery, according to a press release from the device’s manufacturer.

Molli (MOLLI Surgical Inc.) consists of an implantable 3.2 mm marker — allowing for localization of small, nonpalpable tumors — along with a detection wand and visualization tablet. The nonradioactive, electromagnetic marker is implanted in the breast on the day of or less than 30 days before surgery. The surgeon then uses the wand, which detects the marker, to efficiently remove the lesion.

This method improves lumpectomy workflow and safety compared with wire or radioactive seed methods, according to the press release.

“Unlike radioactive seed localization, Molli eliminates any anxiety patients may have related to radiation exposure from radioactive seed localization methods,” Ananth Ravi, PhD, chief science and clinical officer of MOLLI Surgical, said in the release. “Because Molli is based on magnetism, not radiation, hospitals avoid the time-consuming and expensive resources to adhere to radiation safety regulations. With Molli, there are no complex monitoring and disposal protocols, cumbersome and expensive equipment or lost time searching for a misplaced radioactive seed.”