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FDA clearance 510k

WellDoc Receives FDA 510(k) Clearance for Non-Prescription Version of BlueStar® Digital Therapeutic

by HITC Staff 01/19/2017 Leave a Comment

WellDoc

Digital health leader WellDoc has received FDA 510(k) class II clearance for a non-prescription version of the BlueStar® digital therapeutic diabetes management platform. This news comes on the heels of two other significant recent announcements for BlueStar®: the FDA’s clearance of the wireless integration of LifeScan’s OneTouch Verio Flex® blood glucose monitoring system with BlueStar®, and plans to incorporate the American Association of Diabetes Educators’ (AADE) curriculum in the BlueStar®
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Arterys Receives FDA 510(k) Clearance for 4D Blood Flow Image Analysis

by Fred Pennic 11/04/2016 Leave a Comment

arterys-receives-fda-510k-clearance-for-4d-blood-flow-image-analysis

Arterys, a provider of cloud-based medical imaging software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Arterys Software. The FDA clearance will allow Arterys' proprietary cloud platform to be used in clinical settings for the quantification of cardiac flow to collect and process very large data sets in real-time, resulting in fast, comprehensive cardiac exams. The product seamlessly integrates into clinical practice to provide comprehensive, simple and
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biotricity Receives FDA 510(k) Clearance for Wearable Biometric Cardiac Monitoring

by Jasmine Pennic 10/18/2016 Leave a Comment

AT&T Taps biotricity To Power Wearable Medical Devices Medical

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

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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