Medtronic (NYSE: MDT) announced today that the FDA accepted its new Nellcor technology into its STeP program.
The FDA Safer Technologies Program (STeP), a collaborative program, helps reduce the time needed to develop and earn marketing authorization for eligible devices. The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program.
Now, Medtronic says its Nellcor pulse oximetry technology, currently in development, joins the program. The investigative Nellcor technology aims to integrate patient-specific and sensor-specific data into oxygen saturation calculations used in pulse oximetry. According to a news release, acceptance came based on Eligibility Criterion 2a. That outlines a reasonable expectation for the device to improve the benefit-risk profile and reduce the occurrence of serious adverse events.
According to Medtronic, its Nellcor technology addresses current blind spots in pulse oximetry. Namely, it addresses how melanin impacts light absorption, potentially leading to unrecognized hypoxemia in patients with darker skin pigmentation. The company plans to continue partnering and investing in professional education and continued education on this front, too.
“We appreciate the FDA’s designation of Nellcor technology currently in development, which reflects our long-standing commitment to advancing patient safety and clinical confidence in pulse oximetry,” said Samir Ibrahim, senior director of regulatory affairs of the Acute Care and Monitoring business, which is part of the Medical Surgical Portfolio at Medtronic.
Pulse oximetry received heightened attention a few years ago as a method to detect metrics that may indicate COVID-19 infection. As notoriety increased, so did scrutiny, as the FDA and pulse oximeter makers were called on to ensure that the devices delivered consistent, accurate readings across different skin pigmentations after studies highlighted a lack of accuracy with darker skin. The FDA this year issued recommendations urging device makers to address the issue in both new and existing technologies.
