Since 1976, the U.S. Food and Drug Administration (FDA) has allowed manufacturers to apply for an accelerated pathway to bringing their devices to the market. It's called the 501(k) Premarket Notification. In short, if a new device gets proved safe and effective to a device that's already available, the new device can get cleared because it's considered substantially similar to the older one. The FDA also allows for the first-cleared device (also known as the predicate) to be another product
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FDA clearance 510k
New Philips App Enhances Mobility for Caregivers with Real-Time Access to Patient Deterioration
Philips today announced it has expanded its General Care Solution with the new Philips IntelliVue GuardianSoftware mobile client application. The mobile app has received 510(k) clearance from the FDA and leverages the capabilities of Philips’ General Care solution, which includes Early Warning Scoring (EWS), to provide clinicians with the benefit of mobility and optimized workflows. In some hospital medical-surgical units, patient information and color-coded early warning scores are written on a
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University Hospitals Adopts Needle-Free Blood Draw Technology
University Hospitals Cleveland Medical Center adopts needle-free blood draw technology to reduce anxiety and risks for hospitalized patients.University Hospitals (UH) Cleveland Medical Center in Ohio, announced that it has implemented the PIVO needle-free blood draw device from San Francisco-based medical device innovator Velano Vascular at UH Cleveland Medical Center for inpatient blood draws. UH is the first health system in Ohio to deliver this enhanced experience to patients and is helping
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DarioHealth Awarded FDA (510K) Clearance for iPhone Smart Glucose Meter App
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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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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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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