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Posted 28 January 2015 By Alexander Gaffney, RAC for RAPS.org
On 27 January 2015, the US House of Representatives' Energy and Commerce Committee's Subcommittee on Health ...
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By Dan Bowman for Fierce Health IT
A revised version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, currently circulating through Congress in draft form, takes a more "simple and straightforward" approach than its predecessor to health IT regulation, health attorney Brad Thompson tells FierceHealthIT....
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by Angela Shaw for Xconomy
Houston’s Decisio Healthcare, a health IT company that makes software to create a critical care dashboard for ER and ICU staff, is now FDA approved. That distinction is notable, since seeking and obtaining regulatory approval is rare for medtech software companies. Most companies in the electronic health records industry are classified as medical device data systems and, therefore, don’t need the FDA sign-off.
“...
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by Globe Newswire
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by PRWeb
Overland Park, KS (PRWEB) January 12, 2015. Spinal Simplicity, LLC, a spinal device company dedicated to the creation of innovative simple solutions to treat complex spinal disorders, announced today that FDA granted 510(k) marketing clearance for the Minuteman system.
The Minuteman, a pre-packaged sterile supplemental posterior fixation system, offers a minimally invasive alternative to traditional pedicle screws and other...
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by PRNewswire
Submitted by kBLASTER Team on
by PRNewsire
LAKE FOREST, Ill., Jan. 20, 2015 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion...
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by PRNewswire
LITTLETON, Colo. and SEATTLE, Jan. 6, 2015 /PRNewswire/ -- dBMEDx, Inc., a privately-held, wireless medical device company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its novel bladder scanner, the BBS Revolution™, a device...
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The FDA issued a draft guidance on January 16, 2015, titled "Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types". The primary goal of this draft guidance was to describe the use of the de novo classification process to classify accessories of a new type under Section 513(f)(2) of the FD&C...
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Intact Medical said it nailed down expanded 510(k) clearance from the FDA for its eponymous breast biopsy system for preserving larger lesion samples up to 30 mm in diameter....