Archive for December 2022
Promising Remote Patient Monitoring solution, Polso, Achieves 1st FDA Clearance
ChroniSense Medical Ltd. took a step towards its vision of transforming chronic care management with Polso™, the company’s Remote Patient Monitoring (RPM) solution, achieving 510(k) clearance from the U.S. Food and Drug Administration (FDA). Initial indications include monitoring of blood oxygen saturation (SpO2), pulse rate and respiration rate. “FDA clearance is a significant milestone towards…
Read MoreLazurite is Recognized in the 2022 Medical Device Network Excellence Awards & Rankings for its ArthroFree™ System
Medical device and technology company Lazurite has received recognition from Medical Device Network Excellence Awards & Rankings, one of the largest, most prestigious, and widely recognized programs in the industry. Lazurite ranked as Commended for the Innovation, Product Launches and Research and Development categories. All Commended companies will be entered into the Medical Device Network…
Read MoreActiv Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light
Activ Surgical, a digital surgery pioneer, announced that it is has received CE Mark approval for its ActivSight™ Intelligent Light (“ActivSight”). The CE Mark validates that ActivSight meets the requirements of the European Medical Devices Regulation, allowing Activ Surgical to commercialize the enhanced imaging system across the European Union and other CE Mark required regions.…
Read MoreWISE Receives FDA Clearance for its WISE Cortical Strip Bringing Neuromonitoring to the Next Level
WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), announced the FDA clearance of its WISE Cortical Strip (WCS®), a single use medical device intended to be used on the brain surface for Intra Operative Neurophysiological Monitoring (IONM). The WISE Cortical Strip is the first product receiving FDA…
Read MoreHemosonics Awared FDA 510(k) Clearance for Quantra® Hemostasis System with QSTAT® Cartridge
HemoSonics, LLC, a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. “The Quantra Hemostasis System with QStat Cartridge is breaking new ground and leading innovation in the…
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