Apr. 1 at 3:59 PM
$IPIX As of the most recent publicly available information, the full StingRay System — integrating the laser console, fiber optics, MRI software interface (with Siemens and GE imaging systems), and the Advanced Planning Module (APM) — had not yet received FDA clearance. BeaMed was targeting a 510(k) submission for the complete integrated system in Q2 2024, with an anticipated market launch upon clearance. No public announcement of a clearance for the full system has been identified to date.In summary, BeaMed's StingRay project has cleared two of its component-level 510(k) submissions with the FDA: the MANTA laser family (November 2022) and the BeaMed Laser Surgery Fibers (December 2023). The full integrated StingRay System was pending its own 510(k) submission as of the last available public disclosures.
