Author Archives: Andrea Gonzalez

Blunt says Senate still committed to $2B NIH budget boost despite looming cuts

By Mark McCarty, Regulatory Editor The U.S. federal budget blues are not going anywhere anytime soon, but Sen. Roy Blunt (R-Mo.), chairman of a Senate Appropriations subcommittee, said in a March 8 hearing that Senate appropriators are committed to a…

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House repeal-and-replace bill for the Affordable Care Act would end device tax

By Mark McCarty, Regulatory Editor Two committees of the House of Representatives have unveiled the much-discussed legislation that would overwrite several vital features of the Affordable Care Act (ACA), one of which is the controversial 2.3 percent tax on medical…

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Start up Tryton wins FDA approval, Cordis launch for the first branch coronary stent

By Stacy Lawrence, Staff Writer Tryton Medical Inc. has garnered an FDA approval for its Side Branch Stent to treat coronary artery disease with lesions at major branches. This is the first approval for a dedicated bifurcation device in the…

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Boston Scientific receives partial win in TAVR infringement case against Edwards Lifesciences

By Omar Ford, Staff Writer Boston Scientific Corp. received a split decision from a U.K. patent court in its transcatheter aortic valve replacement (TAVR) patent infringement lawsuit against Edwards Lifesciences Corp. The court determined one of Marlborough, Mass.-based Boston Scientific’s…

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Updates for insulin pumps? Tandem develops remote software-based deployment tool

By Omar Ford, Staff Writer Tandem Diabetes Care Inc. has developed a tool for the remote deployment of its insulin pump software. The device updater will allow diabetes patients with the t:slim insulin delivery system to have access to new…

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Grail brings in $900M to ‘Illumina’te growing liquid biopsy space in series B

By Omar Ford, Staff Writer Liquid biopsy startup Grail Inc. said it has raised more than $900 million through the first close of its series B round, putting it on the path to develop a blood-based test for cancer screening….

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Viewray visualizes cancer treatment in real time with Mridian Linac device

By Omar Ford, Staff Writer Viewray Inc. received FDA clearance for the Mridian Linac system, a device that allows clinicians to visualize in real time the movement of tumors and organs during radiation treatment. The Oakwood, Ohio-based company’s technology, which…

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Cagent enters vascular landscape with clearance for a serration balloon catheter

By Omar Ford, Staff Writer Cagent Vascular LLC. has received FDA clearance for its Serranator Alto PTA serration balloon catheter. The Wayne, Pa.-based company’s device is the first of a family of peripheral artery disease (PAD) technologies under development which…

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EU finalizes more stringent CE mark rules with explosive ‘supernova’ of regulation

By John Brosky, Contributing Writer PARIS – The CE mark is dead, long live the new CE mark. Five years after launching a reform of regulations for commercializing medical devices and in vitro diagnostics (IVDs), the European Council released the…

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Boston Scientific recalls first-gen Lotus valves due to locking mechanism issues

By Omar Ford, Staff Writer Boston Scientific Corp. said it was recalling its previous generation Lotus heart valve replacement devices following reports of problems with the products’ locking mechanisms. The Marlborough, Mass.-based company said the issue stems from excess tension…

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