Tag Archive | "Food and Drug Administration"

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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FDA Green Lights Artificial Retina Technology

This week, the Food and Drug Administration sanctioned a groundbreaking first in technology that may restore the gift of sight for visually impaired persons.

The artificial retina, as it’s described, has been given a green light by the FDA. It’s being called the first treatment to give limited vision to individuals who are blind.

The device allows people with a certain type of blindness to detect crosswalks on the street, the presence of people or cars, and sometimes even large numbers or letters.

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Republicans Urge FDA & FCC to Move Faster on mHealth App Approvals

In a rather interesting move, it’s been revealed that Republican House members are urging both the FDA and FCC to move faster in approving mobile medical apps.

In a letter sent to both agencies last week, House members asked for easier regulatory hurdles facing mHealth app developers, in addition to helping speed up the process of getting new apps submitted, approved and available to users.  The authors pointed out that the number of health-related apps for iOS alone grew by more than 250% from 2010 to 2011.

Looking at the growth, legislators are concerned that the “complex regulatory framework” between the various agencies could “inhibit future growth and innovation in this promising market and could preclude tools that help patients better manage their care.”

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mHealth Regulatory Coalition Asks FDA to Revamp and Republish 2nd Draft of mHealth App Guidelines

The mHealth Regulatory Coalition (MRC), who has been very vocal in terms of the guidelines being proposed for mobile medical apps, has asked the FDA to revamp and republish its proposed guidelines — but as a second draft instead of finalized regulation.

On January 20th, the MRC made its request to the FDA in a letter by founding member and attorney Bradley Thompson of Washington, D.C.-based law firm Epstein Becker Green, which has been published to its website.  In it, the MRC explains industry fears that the FDA will scale back its proposed guidelines after being overwhelmed with more than 500 pages of industry comments from more than 100 interested parties.

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ATA: Top 7 Trends Impacting Telehealth in 2012

ATA CEO - Top 7 Trends Impacting Telehealth in 2012The CEO of the American Telemedicine Association (ATA), Jonathan Linkous, has published 7 predictions for telemedicine and the greater telehealth market as we enter 2012.

According to Linkous, his predictions relate to the latest trends that will “shape telemedicine and telehealth in the immediate future,” saying these trends represent “major changes from the existing norm, creating new challenges and opportunities for the industry.”  The ATA has done a lot over the past year to advance telehealth solutions, even offering suggestions and guidance to the FDA in terms of overall mHealth regulation.  Here’s the ATA’s biggest predictions for the coming year . . .

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FDA Issues Draft Guidance for Pharma & Medical Device Makers’ Use of Social Media

The Food and Drug Administration recently published draft guidelines for pharmaceutical and medical device companies on the use of “emerging electronic media,” A.K.A. social media marketing and communication.

Though the FDA notes the proposed guidelines aren’t comprehensive and rather the “first of many planned guidance initiatives,” the move marks the first time the FDA has clearly addressed rules for Pharma and medical device makers’ digital communication via social media and other channels — even specifically mentioning services like Twitter, Facebook and YouTube.

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Washington, DC Based Law firm Offers In-Depth Regulatory Guidance on Telehealth

Telehealth vendor inTouch Health recently commissioned legal guidance from Washington, DC-based law firm Epstein Becker Green, which was subsequently made public and now provides an excellent resource for any organization providing or leveraging telehealth solutions.

The guidance relates to U.S. Food and Drug Administration (FDA) regulation as it applies to telehealth, and was made public to help other users and vendors “understand the regulatory framework within which telehealth may fall, as FDA rules progress.”  The 10-page document covers everything from risk-based regulation of medical devices to recent mhealth regulatory trends and even clinical decision support software as it relates to telehealth.

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