Santa Monica, CA – February 24, 2026 – Kneevoice, Inc., a medical technology company pioneering objective auscultation technology for musculoskeletal care, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Cartilage Evaluation System. The non-invasive system amplifies and records distinct acoustic vibrations within joints to support objective assessment of cartilage and overall joint condition. The company strategically prioritizing initial commercialization concentrated in the knee joint.
The Cartilage Evaluation System captures and analyzes joint sound signatures generated during controlled motion, providing clinicians with objective data to support the evaluation of cartilage condition. By translating mechanical joint interactions into quantifiable acoustic biomarkers, the system offers a novel approach to musculoskeletal assessment.
“FDA clearance marks a major milestone for our team and validates the clinical and engineering rigor behind our technology,” said Gustavo De Greiff, CEO of Kneevoice. “Our cartilage auscultation platform provides clinicians with actionable, reproducible information that enhances clinical decision-making in the assessment of joint health.”
The system is intended for use, at the point of care, as a non-invasive adjunct tool to assist healthcare professionals in evaluating cartilage. The portable platform integrates high-sensitivity acoustic sensors, proprietary signal processing algorithms, and intuitive software to deliver rapid results in clinical settings.
Potential applications include:
- Musculoskeletal evaluation
- Sports medicine and orthopedic assessment
- Longitudinal monitoring of joint condition
- Pre- and post-intervention assessment
- Monitoring biologics treatments and effectiveness
- Monitoring Physical Therapy regiments
510(k) clearance confirms that the Kneevoice Cartilage Evaluation System is substantially equivalent to a legally marketed predicate device, meeting applicable FDA safety and performance requirements.
The Kneevoice Cartilage Evaluation System is now commercially available in the United States.
For more information, visit Kneevoice.com or contact Gustavo De Greiff at gdeGreiff@Kneevoice.com.
About Kneevoice
Kneevoice is revolutionizing the way cartilage health is assessed. By combining cutting-edge audio-arthrography with advanced data analysis techniques, Kneevoice offers a simple, non-invasive, and highly accurate cartilage auscultation tool. Kneevoice empowers healthcare providers and patients alike with real-time insights for better decision-making and proactive care. Kneevoice has a development pipeline including wearable technology, and long term diagnostic support tools.