The U.S. FDA recently convened an advisory committee to address accuracy issues with pulse oximetry devices, with a significant focus on skin pigmentation as a source of noise in the results generated by these class II devices. However, a number of other factors, including obesity and finger size/diameter, also cloud the values generated by pulse oximeters, all of which combine into a large set of variables that premarket studies may have to address before the FDA will issue new marketing authorizations.
The U.S. FDA posted an updated safety communication regarding pulse oximetry accuracy with an eye toward those with darker skin pigmentation, a problem that has surfaced in the medical literature. The FDA said it intends to convene an advisory committee hearing later this year, suggesting that more strict performance standards for pulse oximeters are on the way.
In a move that stunned and dismayed analysts and investors, Masimo Corp. announced a definitive agreement to acquire Sound United LLC Tuesday evening for $1.025 billion. Masimo’s stock (NASDAQ:MASI) plunged on the news of its intended purchase of the high-performance consumer audio products company, plummeting 39% from $228.84 at Tuesday’s close to $139.60 at Wednesday’s opening bell. Volatility led the Nasdaq to suspend trading in the stock for four minutes before 10 am. The stock recovered slightly during the day to close Wednesday at $147.00.
Masimo Corp. managed to obtain and uphold an injunction against True Wearables Inc. regarding a pending patent application, which Masimo said would have disclosed a trade secret for pulse oximeters. However, the injunction is only a preliminary injunction, and thus the road ahead may ultimately yield a disclosure of a trade secret that Masimo has dedicated considerable resources to protect.
PARIS – Tecmoled SAS has just completed the initial testing phase for its wireless oximeter. A prototype has been tested over the past four months on 30 healthy subjects, aged 2 to 70 years, to measure oxygen saturation (SpO₂), heart rate and body temperature.
The U.S. FDA has granted 510(k) clearance to Masimo Corp. for its PVi software tool as a continuous, noninvasive, real-time indicator of fluid responsiveness in select populations of mechanically ventilated adults. PVi, which is an acronym for pleth variability index, quantifies the dynamic changes in perfusion index that occur in a patient during the respiratory cycle.
