Food and Drug Administration (FDA)
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Lawyers Weigh In On FDA App Guidance
The Food and Drug Administration’s recent letter to Biosense Technologies regarding an app that can conduct urine analysis has caused healthcare attorneys to sit up and take notice. Read More »
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Lowering the Bar: Medicine in the 21st Century
As many as 16 million Americans are prone to screaming and pounding on the dashboard when someone cuts them off in traffic. There are 14 million men with low testosterone, 9 million women with low sexual desire -- and tens of millions of people with bladders that are too active and blood sugar that's a little too high. The common thread: All have non-life-threatening conditions that for most of the 20th century were not considered a part of mainstream medicine...
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Mainstreaming ME Research: The 8th Invest In ME International ME Conference, 2013
Mark Berry reports from London on the 8th Invest in ME International ME Conference. Read More »
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Many Device Manufacturers May Miss Looming UDI Deadline
Vendors that sell medical devices to healthcare organizations will be scrambling to meet a mid-September deadline to get unique identifiers and meet requirements to match them with devices and accompanying software. Loftware, a vendor of unique device identifier labeling solutions, recently conducted a survey of about 120 medical device professionals and found that only 15 percent of respondents said they believe their organizations are ready for the September 24 deadline...
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Medical Devices Could Be Lethal in Hands of Hackers
It is embarrassingly easy to hack medical devices, experts warn, creating a new security threat that could have life-or-death consequences. Among the many devices vulnerable to hackers are drug infusion pumps, which could be jimmied to deliver a lethal dose, anesthesia machines and Pacemakers. Many medical devices are produced by legacy companies that are new to designing software...
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Medical Devices Linked to Outbreaks of Superbug Infections
More patients than previously reported have needlessly been infected with antibiotic-resistant bacteria in recent years because of problems linked to a type of medical scope, according to a U.S. Senate health committee report released Wednesday. The report, which was critical of federal oversight of the devices, cited 25 outbreaks of antibiotic-resistant infections at 19 U.S. hospitals, including two centers in Los Angeles, and six in Europe...
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Medicare Prescribes More Brand Name Drugs Than VA
Medicare Part D beneficiaries are two to three times more likely than those covered by the U.S. Department of Veterans Affairs to be prescribed brand name diabetes drugs rather than generics, a new study suggests. Read More »
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MedStartr Finally Brings Crowdfunding To Health Projects
...serial healthtech entrepreneur Alex Fair and founding Kickstarter product manager Mike Pence have set out to give health-focused entrepreneurs and projects a Kickstarter of their own. Medstartr, which launched in beta today, is a crowdfunding platform designed specifically for healthcare companies, providing startups with a vehicle to market their wares, generate awareness and raise capital — direct from strangers, investors, and Doogie Howsers alike...
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MedStartr Offers Crowdfunding For Health IT Firms, Including Itself
Kickstarter has collected $250 million for 24,000 projects since it was founded three years ago, but virtually none of that has gone to health-related companies. “I said, ‘Hey, there’s an opportunity here,’” Fair says. “No one’s really doing health care crowdfunding.”
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Merck 'Evergreens' Off-Patent Lipitor By Creating Combination Drug With No Additional Benefit
Big pharma often gets a rather rough ride here on Techdirt, what with its attempts to stop governments granting licenses for life-saving and low-cost generics in emerging countries, engaging in legal action to prevent drug safety information being released, and paying kickbacks to doctors. Read More »
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mHealth Group Urges FDA To Publish Final Guidance
Some mHealth advocates are getting impatient with the U.S. Food and Drug Administration. The FDA released its preliminary guidelines for the regulation of mobile medical apps in late 2011, and since then the mHealth world has been awaiting the government agency's final document. Read More »
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mHealth Oversight Suggestions Nearing End Of The Beginning
The long and winding road to federal regulation or oversight of mHealth still has some ground to cover, but a key Food and Drug Administration Safety Innovation Act sub-workgroup has tentative suggestions that are about three organizational layers removed from the FDA. Read More »
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mHealth Regulatory Coalition Urges FDA To Release Final Apps Guidance
The mHealth Regulatory Coalition (MRC) on June 21 sent a letter to Department of Health and Human Services (HHS) Secretary Kathleen Sebelius urging HHS, through the U.S. Food and Drug Administration (FDA), to publish the final guidance on mobile medical applications (MMA) "as soon as reasonably possible." Read More »
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mHealth Tools Will Monitor Millions, Reduce Costs
A burgeoning market for healthcare peripherals and increasing smartphone processing power will result in the number of patients monitored by mobile networks to rise to 3 million by 2016, according to a new report on the mHealth sector from Juniper Research.
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Mining Electronic Health Records Reveals Clues Of Harmful Drug Reactions
A study published today in Nature Clinical Pharmacology and Therapeutics showcases the potential power of sophisticated data analytics when applied to electronic health records on a large scale. Read More »
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