Tag Archive | "FDA"

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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FDA Green Lights Marketing of Sentrian Remote Patient Intelligence Solution


FDA Green Lights Marketing of Sentrian Remote Patient Intelligence SolutionFDA clearance — it’s not easy to get, but when you manage to get it, it’s a major accomplishment and a critical component in modern healthcare tech marketing.

Sentrian, a Remote Patient Intelligence company, says it has received confirmation from the Food & Drug Administration that its Remote Patient Intelligence solution reportedly meets the definition of a “medical device” for which the FDA intends to exercise “Enforcement Discretion.”

The designation identifies medical devices that “are not subject to further FDA regulatory requirements at this time” and clears the way for Sentrian to immediately begin marketing its RPI solution broadly in the U.S.
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Posted in mHealth news, Regulation, SmartphonesComments (1)

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