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 Scanlon, deputy chief information security officer at the Department of Health and Human Services, said in a congressional hearing that health care IT systems in the U.S. were not as badly compromised by the WannaCry ransomware as those in other nations, but he added that "in part, it was probably good luck" that the U.S. was not more severely affected....

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 the expanded indication. The minimally invasive valve procedure device segment for patients who are not indicated for traditional surgery is expected to grow over the next decade, analysts predict. "The global transcatheter heart valve replacement and repair [THVR] market was valued at $1.6 billion in 2015 and is expected to expand at a CAGR of 13.9 percent over the forecast...

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 Northern New York. Tip location systems are devices that can be used to aid health care professionals in the bed-side placement of a peripherally inserted central catheter (PICC). Albany, N.Y.-based Angiodynamic's lawsuit claims that Bard has a dominant position in the tip location system market and will only sell the stylet necessary to operate its tip location systems preloaded in...

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 financing series D round led by new investor, Action Potential Venture Capital, a Glaxosmithkline plc (GSK) fund that invests in companies developing bioelectronic medicines. Existing investors, including Medtronic plc, also participated in the round. Artarmon, Australia-based Saluda Medical is developing the Evoke Spinal Cord Stimulator (SCS) system. The device is designed to use the patient's own neural fingerprint to monitor...

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 uniquely relevant event for the agency's efforts to ensure device cybersecurity and, by implication, patient safety. Suzanne Schwartz, the FDA's associate director for science and strategic partnerships, said the term "regulatory science" has a slightly different meaning where device cybersecurity is concerned. "Its about the design ... before they go onto market," Schwartz said, but she noted that the agency...

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 in Washington yesterday. Results from the Post Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2) study revealed two-year improvement in complications for those with severe disease. The study indicated patients who relied on inhaled corticosteroids and long-acting beta-agonists as well as other medications to manage their asthma would benefit from the minimally invasive thermal treatment. "The results...

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 device wraps around the stomach and emulates the effect of conventional weight loss surgery. It also enables gastric volume reduction without permanently changing patient anatomy. Shares of St. Paul, Minn.-based Enteromedics (NASDAQ:ETRM) were up 10.68 percent and closed at $5.08 on Tuesday. The consideration paid by Enteromedics for Bariosurg consists of 1.38 million unregistered shares of Enteromedics common stock, 1...

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. The results of a trial backed by Amsterdam-based Royal Philips NV show that adding noninvasive ventilation, a form of which is a common sleep apnea treatment, in addition to oxygen at home extended the median time to readmission or death for these patients by almost three months. RE-EXAMINING COPD The five-year data were published in the latest issue of the...

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 a confirmatory clinical study for a second generation device. That trial will start enrolling during the fourth quarter, with a target for PMA approval in 2020. The company had previously expected a PMA approval for the Nellix EVAS system during the second quarter of next year. Nellix EVAS is a system to treat infrarenal abdominal aortic aneurysms (AAA); it is...

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 August 2016 demonstrated a direct relation between working in a catheterization lab and developing radiation-induced cancer, cataracts and skin lesions. Wearing a lead-lined apron that weighs 25 pounds for 12-hour work shifts also increases the risks of aggravated orthopedic and muscular conditions. "I have lost several colleagues to brain cancer," Alain Cribier told Medical Device Daily. "We all have musculoskeletal...