We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Avacen, maker of The Avacen Thermal Exchange System (TATES), was hit with a nine-citation FDA warning letter for failing to establish a host of essential GMP procedures. Read More
Devicemakers whose reported payments under the Physician Payment Sunshine Act are frequently disputed could wind up in the crosshairs for a government audit. Read More
Makers of in vitro diagnostics meant for research or investigational use only should take care not to encourage commercial use of their products. Read More
A durable medical equipment provider pleaded guilty Nov. 21 to one count of healthcare fraud in the U.S. District Court for the Southern District of Florida in a scheme the Justice Department says defrauded Medicare of more than $11 million. Read More
The FDA has granted 510(k) clearance for Kinetic Concepts’ V.A.C. Via negative-pressure wound therapy device for patients whose wounds drain 80 mL or less of exudate per day. Read More
Devicemakers attempting to comply with the Physician Payment Sunshine Act do not need to report repairs or training provided under warranty or the names of third parties, such as contractors, that indirectly provide a research payment to a doctor or other entity covered under the law, according to the Centers for Medicare & Medicaid Services. Read More
Accuracy studies for molecular detection methods employed by human leukocyte antigen tests should cover all probes or primers included in the kit, a new FDA draft guidance says. Read More
NeuroPace plans to launch its RNS Stimulator in the U.S. as soon as possible, following last week’s FDA approval of the novel anti-seizure device. Read More