Medical Devices
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Editorial: Open Records Will Make U.S. Medicine Healthier
If you were scheduled to have a medical device such as a knee or hip implanted, would you want to know if your surgeon and/or hospital had a financial relationship with one of the manufacturers?...Now, thanks to one of the successful components of the Affordable Care Act, you can find out what trips, research grants and honorarium are changing hands...
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Eric Topol: Docs Must Adopt Health IT More Quickly
The current shift in the healthcare industry to digitize care unquestionably is the biggest shakeup in the history of medicine, according to cardiologist Eric Topol [...]. Still, Topol (right) says, the industry has a ways to go before it will be able to shake its "slow moving" reputation; the public, he adds, will be key to driving that change. Read More »
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FDA Approves Home Health Platform
Federal regulators have approved Verizon's first foray into the home monitoring space. Read More »
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FDA Guidance On Medical Device Cybersecurity: Too Little Too Late?
The Food and Drug Administration (FDA) has taken an important step forward in better protecting patients and their data with the release of new guidelines on managing cybersecurity risks of medical devices this week. Despite being a step in the right direction, it unfortunately comes late...
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FDA Issues Proposed Rule for Unique Device Identifiers
Five years after a request from Congress, the Food and Drug Administration (FDA) has finally issued a proposed rule that would mandate the placement of unique device identifiers (UDI) on medical devices. Among other things, the use of UDIs will facilitate the reporting of adverse events related to these devices so that the FDA can more quickly address them and recall devices if necessary. Read More »
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FDA Offers Final Guidance For Medical Device Cybersecurity
The U.S. Food and Drug Administration posted newly-minted recommendations for protecting medical devices from attackers...
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FDA Offers Guide On Wireless Healthcare Devices
The Food and Drug Administration has published a guide to the use of wireless healthcare devices in healthcare settings. Read More »
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FDA Releases Device Adverse Event API
Under its openFDA project, the U.S. Food and Drug Administration has released a new application programming interface that returns data from its Manufacturer and User Facility Device Experience (MAUDE), an FDA dataset that contains medical device adverse event reports...
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FDA: Software Failures Responsible for 24% Of All Medical Device Recalls
Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration, which said it is gearing up its labs to spend more time analyzing the quality and security of software-based medical instruments and equipment. Read More »
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Feds Investigating Two Dozen Potential Hacks Targeting Life-Saving Medical Devices
A senior official at the Department of Homeland Security tells Reuters that government experts are now investigating upwards of two dozen instances in which high-tech medical products may be prone to hackers...
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Fiscal Cliff Buzz Muffles Medical Device Industry Message
Several dozen medical device industry execs swarmed the Hill on Thursday, but the buzz over the fiscal cliff might have drowned out their message. The CEOs' pitch to lawmakers: The medical device tax that goes into effect in January is going to cripple the industry and they should repeal it. Read More »
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Google Glass And Other Devices Presenting New Crop Of Privacy Risks
Scarcely a day passes when we don’t hear about some new electronic gadget designed to make our lives more productive, convenient, healthy, or entertaining. Read More »
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Harry Greenspun's 4 Forces Driving Personal mHealth
In a world boasting seemingly futuristic technologies such as Wi-Fi-enabled pill bottles and pills that trigger an e-mail alert upon hitting the stomach, there are still hospitals that have yet to grant patients access to their electronic health records. Read More »
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Health 2.0 and ONC Announce the Winner of the Reporting Device Adverse Events Challenge
Today, Health 2.0 and the Office of the National Coordinator for Health Information Technology (ONC) are announcing the winner of the Investing in Innovation initiative's (i2) Reporting Device Adverse Events Challenge. The i2 initiative utilizes prizes and challenges to facilitate innovation and obtain solutions to intractable health IT problems. Read More »
Health Care Startup Finds Success Despite Public Sector Obstacles
At Axial, Rohde and her team have developed software and mobile apps for doctors, patients, hospitals, nurses, physical therapists and all the parties involved in the 'circle of care' to ensure that a patient's information is available and accessible to anyone who needs it.
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