Senate minority leader Mitch McConnell (R-Ky.) is urging other Republican senators to join him in joining the legal challenge to healthcare reform, after filing a brief asserting that “the law’s mandate that all Americans purchase health insurance is unconstitutional.”
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Feds blast Stryker Biotech, execs
Federal prosecutors blasted Stryker Corp.’s (NYSE:SYK) biotech subsidiary, its former president and three sales reps for seeking the dismissal of the bulk of the 16 criminal charges pending against them in a federal case alleging the illegal promotion of bone putties.
MassDevice On Call: FDA wants you to know: Smoking kills
Warning: Smoking can kill you. The Food & Drug Administration plans to whittle 36 graphic smoking warnings to nine and will seek the public’s input on the proposal of putting them on the front and back of every cigarette packet starting in October of 2012, according to U.S. News and World Report.
MicroAire and Arthrex settle patent spat
MicroAire Surgical Instruments LLC settled a patent infringement and breach of contract lawsuit with Arthrex Inc. involving minimally invasive treatment for carpal tunnel syndrome.
FDA’s former 510(k) chief lukewarm on proposed changes
The Food & Drug Administration’s proposals to re-vamp its most-used medical device clearance protocol are a mixed bag, according to the agency’s former staff director for the program.
Heather Rosecrans, now a regulatory adviser at the healthcare consulting firm Greenleaf Health LLC, told the audience at the Cooley LLP Medical Device Conference in Boston that she’s skeptical of one new feature in particular: the Centers for Devices and Radiological Health’s proposal to create a new Class IIb designation, which would require clinical data.
Children’s scientists work towards an orchestra of stem cell tools
The mysterious process by which an ordinary cell can be transformed into a pluripotent stem cell just got a little clearer. Researchers in Children’s Stem Cell Program have, with collaborators, found that a set of genetic elements called large intergenic non-coding RNAs, or lincRNAs, are involved in the “reprogramming” process.
Cerebral palsy therapy for kids via table-sized touchscreen
Last month, pediatric specialists from across town visited Children’s Hospital Boston for demos of a technology designed to motivate children with cerebral palsy to do their occupational therapy. Created by a multidisciplinary team from Spaulding Rehabilitation Hospital and the Harvard University School of Engineering and Applied Sciences, the system uses a three-foot wide tabletop touchscreen donated by Microsoft Surface — imagine a giant iPad.
AdvaMed appeals for accelerated device approval in Japan
The Advanced Medical Technology Assn. recently returned from a trip to Japan where they pushed for a faster medical device approval process.
AdvaMed, which represents the device industry, said its member companies are "increasingly passing Japan by" because of the country’s onerous regulatory system and "uncertain" reimbursement rules that are based on comparisons with prices in unrelated foreign markets.
Earnings roundup: SurModics tumbles into red ink
Top Medtronic executive enlisted in healthcare reform group
Medtronic Inc. (NYSE:MDT) has long viewed comparative effectiveness research with a wary eye.
While publicly supporting the goals of lowering healthcare costs, the company fears CER — the idea that the government should pay only for treatments that compare favorably to other therapies — could shut out certain medical devices.
Minnesota healthcare group signs Nuance for statewide program
Nuance Communications Inc. (NSDQ:NUAN) signed a deal with the nonprofit Institute for Clinical Systems Improvement for the company’s decision support system.