Dendrite Imaging, Inc. announced that its first product, a surgical camera for intraoperative nerve visualization, has received FDA 510(k) premarket clearance through the Safer Technology Program (STeP). This camera uses near-ultraviolet excitation to induce autofluorescence in nerves without dyes or markers, allowing surgeons to confirm and protect nerves.
BERKELEY, Calif., Dec. 16, 2025 /PRNewswire-PRWeb/ -- Dendrite Imaging, Inc., the world leader in fluorescence-guided surgical nerve imaging, announced today its first product for intraoperative nerve visualization was granted 510(k) premarket clearance by the U.S. Food and Drug Administration (FDA). The product was reviewed as part of the FDA's Safer Technology Program (STeP).
The Dendrite imaging camera induces autofluorescence of neural structures using near-ultraviolet excitation, helping surgeons identify nerves without markers or dye. It is the first system of its kind to offer intraoperative nerve visualization in real time.
"This milestone reflects the strength of our team's submission, involving extensive testing and design controls. We are excited to now bring this camera into surgeons' hands," said Ali Amiri, CEO of Dendrite Imaging, Inc.
"Existing solutions for intraoperative nerve monitoring are limited to audible alerts for motor nerves in specific anatomies. Our non-invasive technology makes nerves "glow" during surgery so that surgeons can now see and protect their structure. By letting surgeons visually confirm the presence of nerves, Dendrite imaging is revolutionizing surgery as we know it," remarked Dr. Raul Rosenthal, co-founder of Dendrite Imaging.
To date, nine peer-reviewed studies have been published using the Dendrite system. The most recent article in the Journal of the American College of Surgeons (JACS), authored by co-founder Dr. Fernando Dip and colleagues, analyzed the use of Dendrite's technology in more than 600 thyroidectomy patients, achieving 100% sensitivity and 99.5% specificity in identifying the recurrent laryngeal nerve - one of the most vulnerable structures in neck surgery.
"This innovation represents a significant advancement to improve safety in operations where nerve injury has historically been a major concern," said Dr. Fernando Dip, co-founder of Dendrite Imaging.
Over 950 surgical procedures have been performed globally using Dendrite for real-time nerve visualization. These cases include mastectomies with reconstruction, axillary dissections, thyroid and parathyroid surgery, central and lateral neck dissections, parotidectomies, cervical plexus exploration, prostatectomy, inguinal hernia repairs, and multiple peripheral nerve operations.
More information on Dendrite's technology and published work can be found at: www.dendriteimaging.com.
Media Contact
Noam Rosenthal, Dendrite Imaging, 1 4242613677, [email protected], dendriteimaging.com
SOURCE Dendrite Imaging
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