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.
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.
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.
An FDA panel yesterday agreed that computed tomography colonography should be a screening option offered to asymptomatic colorectal cancer patients over age 50.
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.
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.
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.