Category Archives: Uncategorized

Witness says good luck may have spared U.S. in WannaCry outbreak

By Mark McCarty, Regulatory Editor Cybersecurity in the health care arena is proving more difficult as hackers forge ahead of responses to those threats, and some believe that medical devices and electronic health records are unusually susceptible to hacking. Leo…

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Edwards Lifesciences is first in mitral valve repair with FDA approval of Sapien 3

By Katie Pfaff Staff Writer Edwards Lifesciences Corp. won FDA approval for its Sapien 3 transcatheter heart valve device for aortic and mitral valve-in-valve procedures. The Irvine, Calif.-based company leads the way in a burgeoning sector of the market with…

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Angiodynamics files antitrust lawsuit against C.R. Bard regarding PICC line

By Omar Ford Staff Writer Angiodynamics Inc. has filed a lawsuit against C.R. Bard Inc., claiming the Murray Hill, N.J.-based company has violated antitrust laws with its catheter tip locators. The lawsuit was filed in the U.S. District Court for…

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Saluda Medical evokes funding from two industry heavyweights in series D round

By Omar Ford Staff Writer Saluda Medical Pty Ltd. is spreading its roots in both the neuromodulation space and the developing bioelectronics medicine market with its latest funding round. The Artarmon, Australia-based company has secured $40 million in an all-equity…

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Cybersecurity on tap for ransomware threat

By Mark McCarty Regulatory Editor The FDA’s latest cybersecurity workshop was inevitably topical, given the rapidly shifting range of threats to device security, but the workshop took place as the Wannacry ransomware crippled hospitals around the world, making this a…

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Boston Scientific RF treatment effective in reducing asthma severity, study finds

By Katie Pfaff, Staff Writer Persistent severe asthma patients may benefit from bronchial thermoplasty (BT) with reduced ER and hospital visits, suggests a Marlborough, Mass.-based Boston Scientific sponsored study of its Alair System, presented at the American Thoracic Society meeting…

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Enteromedics seeks to strengthen position in obesity treatment market with Bariosurg buy

By Omar Ford, Staff Writer Enteromedics Inc. has acquired obesity treatment specialist Bariosurg Inc. Lake Forest, Calif.-based Bariosurg is developing the Gastric Vest, an investigational, minimally invasive, laparoscopically implanted device being studied for weight loss in morbidly obese patients. The…

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COPD study finds noninvasive ventilation, oxygen useful to deter readmission, death

By Stacy Lawrence, Staff Writer Once patients with severe chronic obstructive pulmonary disease (COPD) are hospitalized with a life-threatening event, it’s common for them to be readmitted or even die within the following weeks and months after their initial release….

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Wall Street punishes Endologix as it extends FDA timeline for Nellix system

By Stacy Lawrence, Staff Writer Small cap Endologix Inc. lost about one-third of its valuation after it pushed back the U.S. regulatory timeline for its Nellix Endovascular Aneurysm Sealing System. The Irvine, Calif.-based company said that it needs to conduct…

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Start up Robocath advances robotic assistance for over-radiated cardiologists

By John Brosky, Contributing Writer PARIS – Interventional cardiologists are as pleased to see the arrival of a robotic assistant as the workers at the Fukushima nuclear power plant meltdown site. A study published by the American Heart Association in…

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