Dutch health tech giant Royal Philips has scored FDA 510(k) clearance for its IntelliVue MX750 and MX850 patient monitors.
The monitors, which received an FDA emergency use authorization in 2020 and were cleared in Europe with a CE mark in 2019, are designed to support clinical decisions, manage a patient’s condition and needs, and improve infection control within a hospital setting.
WHY IT...
Wexford, Pennsylvania-based Rijuven has received FDA 510(k) clearance for its CardioSleeve device, which turns a doctor's stethoscope into a mobile-enabled 3-Lead ECG device with digital auscultation. That is, it includes a clinical decision support system that helps doctors evaluate heart murmurs.
According to the company's website, with the CardioSleeve device attached, the stethoscope records...
