Category Archives: Uncategorized

FDA nominee Gottlieb’s industry ties, regulatory approach a concern for critics

By Mari Serebrov, Regulatory Editor Scott Gottlieb’s nomination as the next FDA commissioner is garnering support from industry, but it’s generating some opposition from other quarters. A few lawmakers and Public Citizen, a watchdog group, were among the first to…

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Medtronic tries, again, with drug-coated balloons for below-the-knee PAD

By Stacy Lawrence, Staff Writer Medtronic plc has had a couple of failed trials in below-the-knee peripheral arterial disease (PAD) with its drug-coated balloon (DCB) technology. Now, the Dublin, Ireland-based med-tech giant is giving it another shot with a small,…

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Shares of med-tech firms surge as investors warm to sector, driven by optimism

By Peter Winter, BioWorld Insight Editor Like their biopharmaceutical colleagues, publicly listed medical technology companies have roared out of the gate this year as investors flood back into health care. Companies have benefited from record-breaking market highs being driven by…

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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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