Wire-Free Innovation That Leads to Acquisition
Health Beacons had developed an early prototype for the LOCalizer™ a wire-free, RFID-based breast tumor localization system but needed help transforming it into a regulatory-ready, patient-centric commercial product. The goal was to bring a reliable, ergonomic solution to market that could replace traditional wire localization methods, improving comfort, flexibility, and precision for both patients and clinicians.
Suntra MedTech Solutions took the LOCalizer™ from prototype to product, applying our ISO 13485-certified process to engineer, test, document, and validate the entire system. We enhanced the design with custom sensing coils, a new processor, and a clear visual display featuring intuitive iconography. The device was refined for use in both sterile and non-sterile environments, and aligned to IEC 62304 and ISO 9000 standards. Post-FDA approval, Suntra connected Health Beacons with trusted manufacturing partners and supported the successful transfer to production.
The LOCalizer™ launched successfully and was soon acquired by Hologic, a global medical technology leader. The product now enables wire-free, RFID-guided breast lesion localization, giving surgeons greater precision and patients more convenience enhancing care while simplifying scheduling. Suntra’s comprehensive support played a pivotal role in transforming innovation into impact and in elevating Health Beacons to acquisition success.
