FDA clearance received for Endomag’s Magseed Marker

Surgical guidance company, Endomag asserted that it has sought 510 (k) clearance from the US Food and Drug Administration to further extend the indication of its Magseed magnetic marker to include both the marking of soft tissue as well as the long-term implantation. The Magseed marker has already been used in thousands of lesion localisations for breast cancer. This FDA clearance makes it a wire-free localisation device that can be implanted into any soft tissue with no boundations on the length of time that the marker can be retained.

Magseed is basically a tiny magnetic seed, smaller than a grain of rice literally that can be ascertained using the Sentimag probe. the Magseed marker was evaluated in a number of soft-tissue models including lymph nodes, lung and thyroid tissue. The Magseed marker is at least 60% smaller than competing non-radioactive localisation devices and is made from low-nickel stainless steel. It’s safe to be imaged under ultrasound, X-ray and can be safely scanned with MRI under indicated conditions.

Eric Mayes, CEO at Endomag, said: “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.