The U.S. FDA advised patients and health care professionals about the hazards of hot-cold therapy devices when overusing these systems’ cold mode. The agency recommended that patients consult with their physician regarding the frequency and duration of cold therapy, and to cease use if discoloration or increased pain are experienced. The agency received 15 reports of injury associated with these devices between January 2015 and December 2019, the alert stated.
The FDA said the applicable regulatory review period for the Eversense continuous glucose monitor (CGM) was 3,727 days, 604 days of which were taken up by the review phase. The FDA was responding to a request from the U.S. Patent and Trademark Office, which is calculating a patent term extension for the Eversense, made by Senseonics Inc., of Gaithersburg, Md., adding that the company seeks five years of patent term extension. The term of a patent extension is limited to the regulatory review period.
Attorneys with the law firm of Conley Griggs Partin LLP in Atlanta said on a Sept. 8 press briefing that it has filed suit against Sterigenics Inc., of Oak Brook, Ill., and C.R. Bard Becton Dickinson & Co., of Franklin Lakes, N.J., over what is described as a series of cancer cases blamed on the use of ethylene oxide (EtO). Several other law firms will take part in this series of lawsuits, which at present includes six personal injury cases filed in September, and punitive damages will be sought.