Tag Archive | "FDA"

FDA Authorizes Marketing of the New Dexcom G6

DexCom, Inc., a leader in continuous glucose monitoring (CGM), announced this week that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up.

The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems. The powerful and revolutionary new Dexcom G6® is the first CGM to receive this classification by the FDA.

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RNK Now in Beta for FDA Cleared Telemedicine Stethoscope Software

New Report Reminds That Obstacles for Telehealth PersistMHW recently learned that RNK Products, Inc. (RNK) is now beta testing a simplified version of its FDA approved sSOIP telemedicine stethoscope software.

The software, if you’re not familiar, enables the stethoscope stream to go over the video conferencing audio channel.

This new software version is called PCP-SSP and works with RNK’s flagship PCP-USB stethoscope.
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ResApp Wraps Up Successful Pre-Submission Meeting with FDA

resappAccording to a recent announcement shared with MHW, ResApp Health Limited confirmed that it had a “positive outcome” in its recent Pre-Submission Meeting with the United States Food and Drug Administration (FDA) regarding ResApp’s diagnostic mobile software application, ResAppDx.

During the meeting, we’re told that ResApp received “targeted feedback” from the FDA regarding the proposed US regulatory pathway, clinical study protocols, planned non-clinical evaluations and data requirements.

ResApp can now confirm that it will pursue a direct de novo premarket submission for ResAppDx, initially for pediatric use. A submission for adult use will be prepared in parallel and will be submitted shortly after the pediatric submission. The de novo pathway is designed for innovative medical devices (i.e. those which have no predicate device) where controls provide a reasonable assurance of safety and effectiveness. The de novo process leads to a Class I or Class II classification and has a 120-day review cycle, compared to a 90-day review period for a 510(k).

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AliveCor Expects FDA Clearance of EKG Band For Apple Watch

LifeWatch Signs Agreement With AliveCorAccording to a news release from AliveCor, Inc., a leader in FDA-cleared electrocardiogram (EKG) technology for mobile devices, recently introduced the first medical-grade EKG band for the Apple Watch, Kardia Band (pending 510k clearance, expected availability late spring) along with a new app for smartphones.

The Kardia Band for Apple Watch, and new Kardia app, represent a significant breakthrough in proactive heart health by allowing people to discretely capture their EKG anytime, anywhere.

Users, the announcement explains, can record a single-lead EKG by simply touching Kardia Band’s integrated sensor that communicates with the Watch app, Kardia by AliveCor.

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LifeWatch Confirms FDA Clearance

LifeWatch Confirms FDA ClearanceLifeWatch AG, a developer and provider of medical solutions and remote diagnostic monitoring services to the digital health market, announced today that it has received U.S. Food and Drug Administration (FDA) 510k clearance for its internally-developed LifeWatch Mobile Cardiac Telemetry (MCT) Patch, a 1-lead ECG system.

The LifeWatch MCT 1-Lead Patch is the newest addition to LifeWatch’s cardiac diagnostic monitoring offering, and continues to build on LifeWatch’s commitment to becoming a truly global provider of remote diagnostic monitoring devices and services.
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TactioRPM Touts FDA Registration

TactioRPM Touts FDA RegistrationmHealthWatch has learned that Tactio‘s remote patient monitoring platform TactioRPM is now registered at the U.S. Food and Drug Administration (FDA) as a Class 1 Medical Device Data System (MDDS).

If you’re not familiar, TactioRPM combines science-based mobile apps, web tools, HIPAA-compliant secured cloud services and vendor-agnostic connected health device integrations to allow clinicians to view patient generated data remotely, provide educational content and engage patients in a new mobile-centric, connected healthcare relationship.

TactioRPM also serves up a set of APIs for healthcare organization to build further data integration, process automation and specific applications.
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FDA Green Lights Mobile Continuous Glucose Monitoring System

FDA Green Lights Mobile Continuous Glucose Monitoring SystemOn Tuesday morning in San Diego, Dexcom — a provider of continuous glucose monitoring (CGM) solutions for patients with diabetes — announced that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System.

With wireless Bluetooth technology built into the device transmitter, the G5 Mobile CGM System “is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone.”

This technology, in short, frees users from the need to carry a separate receiver.
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