Reflectance Medical, Inc. has received FDA 510(k) clearance for a noninvasive device that could help clinicians determine whether a patient is in shock or pre-shock or has tissue acidosis in real time at the point of injury or care. It’s the only noninvasive pHm monitoring device, and aims to save providers money by reducing ICU […]
The Food & Drug Administration today announced a program for improving the safety and efficacy of automated external defibrillators. The federal watchdog agency said it’s received 28,000 reports of AED failures in the last five years, yet 300,000 Americans could benefit from treatment from the devices every year. AEDs are designed to treat cardiac arrest […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
ZOLL Medical Corp. receives 510(K) clearance for specially designed Propaq MD Monitor/Defibrillator to be used specifically by the military. ZOLL Medical Corp. (NSDQ:ZOLL) is in the army now, having received 510(K) clearance from the U.S. Food & Drug Administration for a Propaq MD Monitor/Defibrillator designed specifically for use by the military. The announcement comes days […]