We are thrilled to announce that Opticyte has been awarded a second FDA Breakthrough Device Designation for our pulse oximetry technology. This recognition comes on the heels of our first BDD for our Cell O2 technology in 2022, marking an achievement of receiving two Breakthrough Designations for a single device.
▶️ Why This Matters:
The FDA’s Breakthrough Device Program accelerates the development and review of medical devices that demonstrate significant advantages over existing treatments or fill unmet medical needs. This second designation underscores the critical importance and innovative potential of our technology in improving the accuracy of pulse oximetry for patients with dark skin.
▶️ FDA’s Recognition:
The FDA has acknowledged that Opticyte’s technology offers a significant improvement over current pulse oximeters, which often fail to accurately measure oxygen saturation in patients with darker skin tones. This inaccuracy can lead to higher rates of organ failure and mortality among these patients – a long-standing issue with today’s pulse oximeters.
▶️ Our Commitment:
Opticyte is dedicated to enhancing patient care across all demographics. With the FDA’s expedited support, we will continue to advance our technology and, we believe, ensure faster and more accurate diagnostic information that can save lives and reduce healthcare disparities.
▶️ Be Part of the Revolution in Healthcare:
This breakthrough designation is not just a milestone for Opticyte; it’s a leap forward for healthcare equity. By investing in Opticyte, you are supporting a future where we hope every patient receives accurate and equitable medical care.
Invest today via our StartEngine campaign.