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Home » FDA wrestles with mobile medical apps and self-screening devices | MassDevice.com On Call

FDA wrestles with mobile medical apps and self-screening devices | MassDevice.com On Call

March 20, 2012 By MassDevice staff

MassDevice On Call

MASSDEVICE ON CALL — The FDA will meet this month to consider the role the agency will play in mobile medical technologies and patient-driven screening and diagnostics.

The agency forecasts that patients will soon have access to technologies that allow them to self-screen for diseases or conditions via stand-alone kiosks or wireless diagnostic tools like blood pressure readers and blood glucose readers.

Using their own readings gathered from diagnostic apps or devices, patients may be able to determine on their own whether they need a certain medication, or may be able to take their readings to a pharmacist who can meet the prescription without a doctor signature.

"Eliminating or reducing the number of routine visits could free up prescribers to spend time with more seriously ill patients, reduce the burdens on the already overburdened health care system, and reduce health care costs," the agency wrote in a meeting notice in the Federal Register.

The federal watchdog agency plans to meet on questions of handling and regulation and whether certain drugs merit over-the-counter status in light of at-home diagnostic tools at a meeting this Thursday and Friday, according to MobiHealthNews.

TAVI takes the cake as the hot med-tech trend

Edwards Lifesciences’ (NYSE:EW) Sapien transcatheter aortic valve implantation system is the "hottest commercial area right now" in the med-tech space, Piper Jaffray & Co. analyst Thomas Gunderson told the Wall Street Transcript. Gunderson is also keeping a close eye on Medtronic’s (NYSE:MDT) CoreValve system, which is slated to penetrate the U.S. market in 2014.

Abbott CEO Miles White’s take-home narrows in 2011

Abbott (NYSE:ABT) chairman & CEO Miles White’s total take-home slid 6% in 2011, the second consecutive year of narrowing overall pay. White took $24 million in 2011, compared with $25.6 million in 2010 and $26.2 million in 2009, SEC filings show. White received an annual salary bump for each year, but his total package lost value on decreasing stock and option awards.

Experimental treatment "trains" girl’s body to grow new vessels

A 4-year-old girl born with only 1 working heart chamber is undergoing an experimental new treatment to grow a new blood vessel inside her body using a bioabsorbable tube coated with stem cells from the girls’ own bone marrow, the Wall Street Journal reported.

Docs question feel-good benefit of more frequent dialysis

The benefits of daily dialysis may be all in the patients’ heads, new research suggests. Results of a new study comparing daily dialysis with 3 times weekly concluded that the improvement that patients reported had no observed effect on their physical performance, MedPageToday reported.

Filed Under: Food & Drug Administration (FDA), Health Information Technology, News Well, Regenerative Medicine, Replacement Heart Valves, Research & Development Tagged With: Abbott, Edwards Lifesciences, On Call, Personnel Moves

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