Tag: FDA clearance
FDA Clears Biofourmis’ AI-Driven Arrhythmia Detection Platform RhythmAnalytics
Biofourmis, a Singapore-based health-tech startup, has received FDA clearance for its cloud-based software, RhythmAnalytics, which helps healthcare professionals in detecting cardiac arrhythmia, or irregular...
Omron’s Blood Pressure Monitor with EKG Available for Pre-Order from April 15th
Omron Healthcare has received FDA clearance for its
Complete™, blood pressure monitor with EKG capability, and the company said it
will start taking pre-orders on April...
Spry Health’s the Loop System Wearable Gets FDA Clearance for Monitoring COPD Patients
The US Food and Drug Administration (FDA) has given (501k) clearance
to the Loop System, a continuous remote monitor for patients with COPD.
Developed by Spry...
Senseonics’ New Program Geared Towards Patients with High-Deductible Insurance Plans
Senseonics, a company well-known for its continuous glucose
monitoring (CGM) system announced a new program called Eversense Bridge for patients
who carry a high-deductible insurance plans...
Itamar Medical’s WatchPAT 300 is a Simple and Reliable Home Sleep Apnea Detection System
Caesarea, Israel-based Itamar Medical launched WatchPAT 300,
the next generation WatchPAT system for home sleep apnea testing. New developments in the WatchPAT 300 are
designed to...
Masimo MightySat Rx Pulse Oximeter Gets FDA Clearance to Measure Breathing Rate from Fingertip
Masimo has been granted FDA clearance for its MightySat Rx fingertip pulse oximeter to be used to spot check the respiration rate. The addition...