Opticyte announced today that its Cell O2 patient monitor received breakthrough device designation from the FDA.
Seattle-based Opticyte designed Cell O2 to use noninvasive optical spectroscopy technology. It measures and detects systemic low oxygen levels inside cells. This provides continuous monitoring of cellular oxygen levels during hospitalization.
The startup said in a news release it could reduce organ failure for those with sepsis, trauma and myocardial infarction.
“We’re pleased the FDA recognized the strength of our data and the promise of our technology to deliver reliable and actionable cellular oxygenation readings for medical staff–often working in emergency medicine–to more effectively prevent organ failure and save lives,” said Lori Arakaki, Opticyte co-founder and CEO. “This new designation will allow us to more quickly reach sepsis, trauma, and cardiac surgery patients with organ dysfunction who are on the verge of organ failure.”
A first-in-human observational study of nearly 150 patients took place at Harborview Medical Center and University of Washington Medical Center in Seattle. The study documented real-time readings of low cell O2 in patients with sepsis. The company is currently working on additional studies to investigate cell oxygenation in patients across indications and care settings.
Opticyte addresses skin tone differences in patient monitoring
One area in which Opticyte intends to ensure accuracy comes in the form of pigmentation. The company said it studied more than 130 people with a variety of physical characteristics. That includes lighter and darker skin tones. This helped develop the training and testing data for its machine learning algorithm.
“Opticyte’s commitment to ensuring people with different skin tones and pigmentation are included in the foundation of their technology, dramatically improving the standard of care and saving lives for the hundreds of thousands of people suffering from organ dysfunction, makes us especially proud to support their efforts,” said Nate Doran, a Seattle-based micro VC.
Skin pigmentation represents an area of intrigue in the patient monitoring space. Recently, the FDA scrutinized whether some pulse oximeters may offer less accuracy among people with darker skin. Over the summer, Democratic U.S. senators called on the agency to study the issue more.
During the early stages of the COVID-19 pandemic, pulse oximeters became a useful tool for obtaining certain metrics that may indicate infection. Reports suggested disparities in pulse oximetry depending on skin color.