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The FDA has warned an online marketer of genetic tests to pull its products off the market until it obtains regulatory clearance, saying the company has not demonstrated that the tests do what it claims they do. Read More
An interim report on the joint assessments of EU device notified bodies (NBs) shows there is room for improvement in the planning, scope and depth of surveillance activities. Read More
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
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
FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More
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