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...

The FDA warning letter has been around for more than a quarter century, and questions about their use and abuse crop up periodically. Perhaps it's time again to ask whether warning letters actually fulfill their purpose, but one gets the feeling that like the horseshoe crab, this is a species that is unresponsive to allegations of obsolescence. Before we go off on warning letters, however, we should acknowledge that Congress is looking into legislation dealing with the medical device inspection imbroglio. But will that change anything about the warning letter...

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 U.S. for first-to-market approvals. In reforming its law, the European Union has made the new Medical Device Regulation (MDR) so onerous, so complex and so uncertain that the formidable formalities of the U.S. FDA now seem user-friendly, according to discussions during several panel sessions at EuroPCR 2017, Europe's largest congress for interventional cardiology. "The pendulum has swung. The early feasibility...

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 or not to stent a coronary lesion. The results of the combined results from DEFINE-FLAIR and IFR-SWEDEHEART were already known to cardiologists, having been published in March in the New England Journal of Medicine and concurrently presented at the meeting of the American College of Cardiology. New at EuroPCR was the roll-out of the system for performing the assessment by...