Tag Archive | "Food and Drug Administration"

FDA Green Lights Artificial Retina Technology


FDA Green Lights Artificial Retina Technology   Retina National Eye Institute mHealth Food and Drug Administration FDA 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


Republicans Urge FDA & FCC to Move Faster on mHealth App Approvals   regulatory approval mobile medical apps mobile medical applications mobile medical app approval mHealth apps mHealth applications mHealth medical apps Food and Drug Administration Federal Communications Commission FDA FCC 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


mHealth Regulatory Coalition Asks FDA to Revamp and Republish 2nd Draft of mHealth App Guidelines   MRC mobile medical apps mobile medical applications mHelath regulation mHealth Regulatory Coalition mHealth apps mHealth applications mHealth app guidelines Food and Drug Administration FDA proposed guidelines FDA digital health apps 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: Top 7 Trends Impacting Telehealth in 2012   virtual medical centers telemedicine trends telemedicine telehealth trends telehealth standard of care remote monitoring remote management reimbursement models multi nationalization mobile healthcare mobile health mHealth Food and Drug Administration FDA clinical enterprises ATA American Telemedicine Association The 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


FDA Issues Draft Guidance for Pharma & Medical Device Makers Use of Social Media   social media marketing social media communication social media pharmaceutical pharma mobile healthcare regulations mobile healthcare mobile health regulation mobile health guidelines mobile health mhealth regulation mhealth guidelines mHealth healthcare social media communication healthcare communication Food and Drug Administration FDA guidelines FDA Draft Guidelines FDA draft guidelines 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


Washington, DC Based Law firm Offers In Depth Regulatory Guidance on Telehealth   telemedicine telehealth regulatory guidance mobile healthcare regulation mobile health regulation mhealth regulation inTouch Health Food and Drug Administration FDA regulation FDA 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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FDA Survey Finds Most Popular Uses for RFID and RTLS in Hospitals


FDA Survey Finds Most Popular Uses for RFID and RTLS in Hospitals   the FDA RTLS RFID Real Time Location Services Radio Frequency Identification mobile healthcare mobile health mHealth inventory control system hospitals hospital equipment tracking hospital equipment healthcare facilities Food and Drug Administration fixed RFID readers FDA CVVH asset tracking active tag A new, relatively small, survey of nine hospitals sponsored by the FDA recently found that the primary uses of Radio Frequency Identification (RFID) and Real-Time Location Services (RTLS) relate primarily to patient and asset tracking among healthcare facilities.

In terms of RFID deployment, the most popular use cases were found to be within infusion pumps, portable monitors, wheelchairs, beds, and ventilators.  In terms of where RFID devices are being installed in hospitals, most have fixed RFID readers in their facilities while others do not, with those who have fixed readers having them installed on door frames, in hallways, patient rooms, and inside cabinets.  Non-fixed readers are part of a “wand system” and are located in consoles, or are readers that plug into outlets.

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