Sunday, May 5, 2024
EnsoData, a pioneer in healthcare AI, achieved FDA 510(k) clearance for groundbreaking technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry (pulse ox) devices. Powered by EnsoSleep PPG scoring, widely available and wearable pulse ox technology can be deployed for a high-quality, accessible, and cost-effective approach to diagnosing sleep […]
Owlet announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant health data, having monitored more than 1 million babies, and with BabySat, combines its consumer-first expertise with hospital-grade monitoring accuracy. “Our […]
The United States District Court for the Central District of California has ruled that a former Masimo engineer misappropriated trade secrets related to Masimo’s pulse oximetry technology. The former Masimo engineer, Marcelo Lamego, also served as Chief Technical Officer at Cercacor, a Masimo spinoff that owns certain license rights to […]
Masimo announced the findings of an abstract presented at the Society for Technology in Anesthesia 2022 Annual Meeting, which reviewed retrospective pulse oximetry data and concluded that there was no clinically significant bias based on ethnicity for black and white volunteer subjects monitored with Masimo SET® pulse oximetry and RD […]
Masimo announced FDA clearance of the Rad-G™ Pulse Oximeter, a rugged handheld device that provides clinically proven SET® pulse oximetry, respiration rate from the pleth (RRp®), and other vital parameters for both spot-checking and continuous monitoring. With its long-lasting rechargeable battery, robust rubber casing, lightweight, and a convenient new direct-connect sensor […]
Masimo announced the results of a prospective study published in the International Journal of Neonatal Screening in which researchers in Marrakesh, Morocco, conducted the first Moroccan study on critical congenital heart disease (CCHD) screening for newborns using Masimo SET® pulse oximetry.1 The authors concluded that “Our results encourage us to strengthen screening for […]
Masimo announced the results of a study published in Pneumonia in which independent researchers in New Delhi, India, investigated the accuracy of Masimo RRp® on pediatric patients with the Rad-G™ Pulse Oximeter by comparing it to clinician-determined values while performing routine assessment of children admitted to outpatient and emergency departments.1 RRp provides respiration rate […]
Introduction Sleep apnea, with an estimated incidence between three and seven percent in the general population, is a common disorder.1 Currently, either an at-home sleep test or overnight polysomnographic test is necessary to diagnose sleep apnea. Both of these evaluations are at times cumbersome. Consequently, patients may be unwilling to […]
