DarioHealth, an Israli-based global digital health company with mobile healthand big data solutions, announced today that the United States Food and Drug Administration (FDA) has granted Pre-market Notification (510(k)) clearance for the Company's Lightning®-enabled version of the acclaimed Dario Blood Glucose Monitoring System which enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices (SMD). Consumers in the U.S. market will be able to receive the same quality user
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FDA Cleared Devices
Biotricity Awarded FDA 510(k) Clearance for its Biometric Remote Monitoring Device
Biotricity - a medical diagnostic and consumer healthcare technology company dedicated to delivering innovative, biometric remote monitoring solutions, that details how the Company has received its 510(k) clearance for its Bioflux device with the U.S. Food and Drug Administration (FDA). This latest 510(k) is the final FDA requirement needed for Biotricity to bring to market Bioflux in the U.S.Bioflux consists of a proprietary mobile ECG monitoring device and an ECG viewer software package, that
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Eko Duo Receives FDA Clearance to Market Combined Digital Stethoscope/ECG Smart Device
Eko Devices, a provider of mobile acoustic cardiac monitoring solutions has received FDA clearance to market its latest solution, Eko Duo, a smart heart monitor transforming how patients and their physicians monitor heart disease. Eko Duo combines the digital stethoscope and ECG for monitoring patients in the clinic or at home into a compact, handheld device.The DUO, which patients can obtain with a prescription, can seamlessly stream cardiac data (stethoscope + ECG) to specialists, providing
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Oxitone Medical Receives FDA 510(k) Clearance for Wrist-Sensor Pulse Oximetry Bracelet
Oxitone Medical (Oxitone), an Israeli-based medical device and digital health company developing wearable monitoring solutions has received 510(k) clearance from the FDA for its wrist-sensor pulse oximetry bracelet Oxitone 1000. The wrist-sensor pulse oximeter Oxitone 1000 measures critical vital signs such as SpO2 and pulse rate with the same precision as conventional fingertip pulse oximeters.The Oxitone solution has been validated in pilot studies in a number of medical settings including
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WellDoc Founders Launch FDA-Cleared Mobile Insulin Titration App for Diabetes Management
The team that created the first FDA-cleared mobile app for diabetes management at WellDoc has launched a completely new digital health company, Amalgam Rx. The new company is focused on developing next-generation, evidence-based digital therapies that empower and engage patients with chronic diseases. Amalgam’s first product, iSage Rx is the first FDA 510(k)-cleared, prescription-only, mobile insulin titration app of all brands of basal insulin including Lantus, Levemir, Toujeo, Tresiba and
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Biotricity Files for Final FDA 510(k) Clearance for Remote Cardiac Monitoring Wearable
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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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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