Endomag’s Magseed Marker Receives FDA Clearance for Long-Term and Soft Tissue Implantation

Endomag, the surgical guidance company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to extend the indication of its Magseed magnetic marker to include both the marking of soft tissue and long-term implantation. The Magseed marker has already been used in thousands of lesion localizations for breast cancer. This FDA clearance makes it the world’s only wire-free localization device that can be implanted into any soft tissue with no restrictions on the length of time that the marker can remain in the body.
 
Magseed is a tiny magnetic seed, smaller than a grain of rice, that can be detected using the Sentimag probe. In order to support its extended indication, 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 percent 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 magnetic resonance imaging under indicated conditions. Crucially for radiologists and surgeons, the Magseed marker cannot be broken on deployment, following implantation, or damaged with electrocautery during surgery.
 
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.”
 
Endomag’s Sentimag platform and its surgical markers, Magseed and Sienna, are designed to guide the accurate removal of cancer, while helping to maximise the amount of healthy tissue retained. These products have been used in over 30,000 tissue localizations at more than 300 hospitals. The Sentimag system continues to increase its global footprint, with regulatory approvals in Europe, the United States, Canada, the Middle East, Africa, Australia, New Zealand, Singapore, and Hong Kong.
 
The Magseed marker is exclusively distributed throughout North America by Leica Biosystems.
 
Endomag’s mission is to improve the standard of cancer care for everyone, everywhere, by providing more accurate, convenient and less-expensive solutions for diagnosis and treatment. Endomag has developed a minimally-invasive surgical guidance system, which can locate early-stage and impalpable tumours, and help determine whether the cancer has spread. The system uses magnetic field technology, providing a safer, more comfortable and efficient option, over alternative techniques. The system has been used in over 30,000 procedures across 300 hospitals in 30 countries and is the subject of 12 clinical publications, all confirming its efficacy compared with current standards.