Surgical guidance company Endomag said today that its Magseed magnetic marker won 510(k) clearance from the FDA, extending the product’s indication to include the marking of soft tissue and long-term implantation.
The company’s Magseed device is the only wire-free lesion localization device on the market that can be implanted into any soft tissue with no restrictions on how long the marker can remain in the body, according to Endomag.
The Magseed marker is 60% smaller than other non-radioactive localization devices, Endomag explained, and is safe to be imaged with ultrasound, X-ray and MRI, under certain conditions.
The device, which is smaller than a grain of rice, is designed to be detected by the company’s Sentimag probe.
“Our team’s ability to innovate for the benefit of clinicians and their patients continues to strengthen, and it’s great to be able to deliver another ‘world first’ with this extended indication for Magseed,” CEO Eric Mayes said in prepared remarks.