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FDA clears more Chocolate PTA balloon catheters | Regulatory Roundup

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MassDevice.com Regulatory Roundup

 TriReme touts FDA okay for more Chocolate PTA balloon catheters
Pleasanton, Calif.-based vascular devices maker TriReme Medical won expanded FDA indication for additional sizes of its Chocolate percutaneous transluminal angioplasty balloon catheters.

"This latest regulatory approval broadening the available size matrix of the Chocolate PTA balloon marks yet another important milestone for TriReme Medical," president & CEO Eitan Konstantino said in prepared remarks. "There is more to come; our goal is to provide a broad range of innovative tools to improve outcomes in patients suffering from complex vascular disease."

TriReme initially won 510(k) clearance late last year for the Chocolate line of devices to treat occluded peripheral arteries.
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 InTouch lands 510(k) win for remote cute care systems
Santa Barbara, Calif.-based InTouch Health won expanded FDA 510(k) clearance for a range of its telemedicine systems to enable active patient monitoring in environments where immediate clinical action may be required. The new clearance specifically targets surgical, cardiovascular, neurological, pre-natal, psychological and critical care monitoring, assessment and examination.
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 Maquet wins CE mark for new anti-microbial vascular graft
Maquet Cardiovascular won CE Mark approval in the European Union for its Intergard Synergy vascular graft, made with anti-microbial compounds to prevent vascular graft infections.
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