Tag Archive | "FDA"

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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Medtronic Gets FDA Green Light for MiniMed Connect


Medtronic Gets FDA Gteen Light for MiniMed ConnectA representative from medical technology company Medtronic tells mHealthWatch that the organization has secured U.S. Food and Drug Administration (FDA) clearance for MiniMed Connect.

MiniMed Connect is designed to provide a mobile connection to critical information for managing diabetes.

We’re told that the resource in question is the first product to enable people with diabetes to discreetly and conveniently view their insulin pump and continuous glucose monitor (CGM) data on a smartphone and provides remote monitoring and text message notifications for their loved ones.

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The Need For Well-Designed And Tested Insulin Apps Is Still Alive And Well


The Need For Well-Designed And Tested Insulin Apps Is Still Alive And WellWhile you can head online and find close to 50 paid apps designed to determine proper dosing for insulin, a recent study by Global eHealth Unit at the Imperial College London has found that the vast majority of these apps fall short. In fact, many of these apps were developed during the app boom, and have not been updated in years.

While an app that can accurately calculate mealtime dosing for short-acting insulin after entering in carbohydrates, pre-meal blood sugar, physical activity, and other pertinent information seems as though it would be both easy and convenient, most apps struggle with even these basics. The study, highlighted by MedPage Today, found that:

  • 30% of the apps would not share their formula
  • 91% had incorrect techniques for numeric inputs
  • 67% showed risk factors for inappropriate dose recommendations because their actual calculation did not match their formula
  • 24% did not operate consistently

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FDA Plans to Take a Hands Off Approach to Apple Watch


FDA Plans to Take a Hands Off Approach to Apple WatchWith Apple Watch set to launch on April 24th, questions have swirled around how the FDA might intervene to somehow regulate the first-ever wearable released by Apple.

But this week, the FDA is making their position on the matter very clear. They want very little, if anything, to do with putting up regulatory hurdles for Apple Watch.

“We are taking a very light touch, an almost hands-off approach,” Bakul Patel, the FDA’s associate director for digital health, is quoted by Bloomberg. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

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