biotricity, a Redwood City, CA-based healthcare technology company has filed for a second and final 510(k) for the hardware portion of its remote cardiac monitoring software and device, Bioflux solution with the U.S. Food and Drug Administration (FDA). The announcement follows a previous milestone where Biotricity received FDA approval for the software portion of its remote cardiac monitoring wearable.This 510(k) is the final regulatory requirement needed for Biotricity to bring its Bioflux
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FDA clearance 510k
WellDoc Receives FDA 510(k) Clearance for Non-Prescription Version of BlueStar® Digital Therapeutic
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
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
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
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
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
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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