Author Archives: Andrea Gonzalez

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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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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New CE mark rules make the FDA seem user-friendly for cardiovascular devices

By John Brosky, Contributing Writer PARIS – One week before regulations governing the CE mark for medical devices formally takes the force of law, makers of cardiovascular devices have already turned their backs on Europe and are headed to the…

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Novel diagnostic beats FFR vindicating Philips-Volcano IFR platform for cath labs

By John Brosky, Contributing Writer PARIS – A meta-analysis covering 4,529 patients presented at EuroPCR closed the door on a five-year argument over what diagnostic tool will be the gold standard in the catheterization lab for helping physicians decide whether…

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Thermo Fisher to buy contract drug developer, manufacturer Patheon NV for $7.2B

By Stacy Lawrence, Staff Writer Thermo Fisher Scientific Inc. will acquire drug development and delivery services provider Patheon NV for $7.2 billion, including $2 billion of debt assumption. Diagnostics and laboratory-focused Thermo Fisher expects that the addition of the Durham,…

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Watchman effective in stroke reduction for non-oral anticoagulation patients

By Omar Ford, Staff Writer CHICAGO – Results from the EWOLUTION registry show that Boston Scientific Corp.’s Watchman Left Atrial Appendage (LAA) Closure device was effective in stroke reduction for patients with non-valvular atrial fibrillation (AF), including those patients deemed…

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