An FDA panel yesterday recommended that the FDA reclassify membrane lung for long-term pulmonary support systems, or so-called extracorporeal membrane oxygenator circuits and accessories, from the highest-risk Class III category to the less burdensome Class II, with special controls.
AMC Health lands $29M VA contract
Telehealth solutions firm AMC Health said it expanded its government services division with a 5-year U.S. Veteran Affairs Dept. contract worth up to $28.8 million.
FDA panel recommends reducing regulatory burden on cardiac devices
A panel of experts yesterday recommended the FDA down-classify several types of cardiac devices from the high-risk Class III category to the less-stringent Class II.
FDA panel backs computed tomography for colon cancer
An FDA panel yesterday agreed that computed tomography colonography should be a screening option offered to asymptomatic colorectal cancer patients over age 50.
NxStage Medical urges Medicare to pony up for home hemodialysis
Home hemodialysis system maker NxStage Medical (NSDQ:NXTM) urged the Centers for Medicare & Medicaid Services to increase coverage for home hemodialysis training for patients with end-stage renal disease.
TAVI: Edwards Lifesciences’ Sapien valve safe for redos, may lower diabetic death toll
ESC 2013: Pacemakers set life expectancy back to normal, researchers say
A slow heart rhythm puts patients at risk of early death, but a cardiac implant may help reset those odds, according to a Dutch study presented this week at the European Society of Cardiology Congress in Amsterdam.
A study of pacemakers in 23 Dutch hospitals found that devices implanted to treat slow heart rhythm helped restore normal life expectancy.
Dental: German court enforces Align Tech’s injunction against Ortho Caps, Rasteder KFO
CardioKinetix treats 1st Asian patients with Parachute cardiac implant
Four patients in Kuala Lumpur, Malaysia were successfully treated with CardioKinetix’s catheter-based Parachute ventricular partitioning device, the Menlo Park, Calif.-based firm announced late last month.
Medical affairs dos and don’ts: CEI study probes best practices
New companies tend to decide pretty early on whether to build medical affairs teams separate from their commercial operations, a decision that may hold implications for later compliance concerns.
More than half of the companies surveyed by Cutting Edge Information chose to define centralized medical affairs teams, noting it as a top concern early in their organization.