Edwards Lifesciences Corp. made a splash recently with the U.S. FDA approval of the Evoque tricuspid valve replacement device, but is also pressing Centers for Medicare and Medicaid Services to provide a coverage framework for this class of devices.
Exact Sciences Corp.’s Cologuard Plus received U.S. FDA pre-market approval as a non-invasive colorectal cancer home screening test. The next-generation, stool-based assay, developed in conjunction with the Mayo Clinic, reduces false positives by 30% compared to the original Cologuard test without diminishing its sensitivity for cancer or advanced adenomas.
Organox Ltd. gained approval from Health Canada for its Metra system for use during liver transplantation. The system utilizes normothermic machine perfusion to maintain donor livers under physiologic conditions prior to transplantation.
Medtronic plc reported a voluntary recall of certain insulin pumps after customers said a single drop, bump, or physical impact could shorten their battery life.
China’s National Medical Products Administration wrapped up a revision of its device classification procedures, providing entries into one of the world’s largest markets a mechanism for obtaining means for determining the risk of a novel device type.
It’s well past time for the U.S. FDA to end its silence on what device patents can be listed in the Orange Book as part of a drug-device combination product, Sen. Bill Cassidy (R-La.) said in an Oct. 1 letter that took FDA Commissioner Robert Califf to task for letting the FTC do the FDA’s job.
Setpoint Medical Inc. received U.S. FDA investigational device exemption approval to initiate a study of its neuroimmune modulation platform in people living with relapsing-remitting multiple sclerosis. Setpoint plans to launch the 60-person trial in 2025 to evaluate the use of its implantable neurostimulation device to slow or reverse the nerve damage characteristic of multiple sclerosis.
Tokyo-based Olympus Corp. launched a new video imaging platform called Visera S (OTV-S500) in Europe and select Asian countries September 2024 while advancing more rollouts for the product worldwide.
The U.S. Patent and Trademark Office opted to allow the 2.0 pilot version of the After Final Consideration Program to expire, bringing to an end a program that ran for longer than a decade.
The controversy over conflicts of interest for Jeff Shuren, formerly the director of the U.S. FDA’s device center, reached Capitol Hill and may lead to an executive branch investigation into the matter.
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