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biotricity Receives FDA 510(k) Clearance for Wearable Biometric Cardiac Monitoring

by Jasmine Pennic 10/18/2016 Leave a Comment

biotricity Receives FDA 510(k) Clearance for Wearable Biometric Cardiac Monitoring

biotricity, a Redwood City, CA-based healthcare technology company has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a key component of its remote cardiac monitoring software and device, bioflux. Available only by subscription, bioflux will monitor a patient’s heart rhythm and send data in real-time to a 24-hour monitoring lab. If a patient is in cardiac distress, an alert will be sent to the monitoring center, which will in turn contact the patient to offer
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AirStrip Granted FDA 510(k) Clearance, Patent for AirStrip ONE App

by Jasmine Pennic 09/21/2016 Leave a Comment

AirStrip Granted FDA 510(k) Clearance, Patent for AirStrip ONE App

AirStrip announced it has received FDA 510(k) clearance to a web client for the AirStrip ONE® mobile interoperability platform and app that can be run on desktops and laptops using Internet Explorer and Google Chrome. AirStrip ONE® provides a single, data- and vendor-agnostic platform that connects clinicians with the right information at the right time, via the most convenient device at hand.The company also recently received a U.S. patent for new functionality: ECG waveform 'visual calipers'
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Philips Receives FDA 510(k) Clearance of Clinical Management Solution

by HITC Staff 03/01/2016 Leave a Comment

Philips Receives FDA 510(k) Clearance of Clinical Management Solution

Philips Respironics, today announced it received 510(k) FDA clearance for its cloud-based clinical management software application, Care Orchestrator. Care Orchestrator is a first to market solution that seamlessly connects clinical data and informatics for clinicians, caregivers and patients from the hospital into the home. Powered by Philips HealthSuite digital platform, complete view of sleep and respiratory patient data now available in one place for easy information exchange Building on
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Interview Podcast:FDA Approved GE Centricity Radiology Mobile App with Lawrence White Pt. 1

by Fred Pennic 02/06/2012 Leave a Comment

Interview Podcast:FDA Approved GE Centricity Radiology Mobile App with Lawrence White Pt. 1

In late November of last year, GE announced that its Centricity Radiology Mobile Access app has received FDA 510(k) clearance. The app enables radiologists to use their iPhones and iPads to remotely access, review and diagnose patient CT and MR images from the hospital’s Centricity PACS within moments of the scans being taken, reducing test result wait times. Radiologists can quickly find relevant images and reports through the AccessNOW app, which provides the ability to search Centricity PACS
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