Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Integra Class I recall: Firm's NeuroSciences unit initiated a recall Oct. 3 of its Gravity Compensating Accessory (GCA) used in implanted shunt systems because the device may leak cerebrospinal fluid, potentially causing inflammation of brain, spinal cord or abdominal membranes, or failure of the shunt system, FDA says in a Dec. 11 Class I recall notice. The GCA is part of a system that redirects excess fluid from the brain to the abdomen so that too much fluid does not build up while sitting or standing. Integra sent letters to customers on Oct. 9, as well as to physicians. The devices were manufactured between January and May, and were distributed from Feb. 22 to June 1You may also be interested in...
New Products In Brief
Right side of heart pump: FDA grants Humanitarian Device Exemption on Oct. 7 to Levitronix' CentriMag right ventricular assist system for temporary support of critically ill patients with a failing right ventricle. Safety data from two multi-center clinical trials showed that the benefits of CentriMag outweigh its risks, FDA says. The device is designed to support patients up to 14 days or until a heart transplant or long-term heart assist device can be implanted. "While severe right-side heart failure is uncommon, it can lead to death," states FDA. "It is often caused by left-side heart failure or, in unusual cases, by heart surgery.
‘Supplement’ On CBD Product Label A Bullseye For US Litigants, Says Attorney
Two CBD marketers warned by FDA in a recent crackdown are targeted in class action complaints alleging they made unsubstantiated health claims and mislabeled ‘illegal drug’ products as supplements. Complaints are a wake-up call to CBD wellness industry to ensure claims are substantiated, as the class action bar is on the prowl following the agency’s 15 warning letter blast in November.
HBW Market News: GNC US Chief, Clasado Commercial Head, Barentz Funding
GNC hires Josh Burris as chief US officer; Clasado BioSciences adds Bellchambers as commercial director; and Barentz plans expansion with Cinven investment.
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