Masimo Corp. received a pinch of good news with the U.S. FDA’s clearance of its medical-grade fingertip pulse oximeter, Mightysat Medical, for over-the-counter (OTC) sale. The device uses the same ...

The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical ...

Masimo Corporation MASI recently announced the FDA clearance of its Masimo SET-powered MightySat Medical Pulse Oximeter, available Over-The-Counter (OTC) to consumers without a prescription. This ...

Please provide your email address to receive an email when new articles are posted on . The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the ...

Pulse oximeters were invented in 1974, and the evidence of flawed pulse oximeter readings in people with dark skin dates to the 1980s. One study, published in 2022, found that among more than 3,000 ...