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.
Guardant Health has moved to dismiss a lawsuit Illumina filed against it for allegedly stealing trade secrets relating to next-generation sequencing oncology tests. Read More
Medtronic and DaVita have teamed up to form a new medical device group — provisionally named “NewCo” — that will focus on independent kidney care. Read More
An FDA investigator handed Lincotek Medical a Form 483 for inadequate corrective and preventive action (CAPA) and validation procedures after an inspection last November of the company’s facility in Vandalia, Ohio. Read More
Efforts to improve diversity in clinical research can be greatly improved when sponsors take a hard look at their current practices and protocols, work directly with sites and consider adding sites well-suited for the task, a new report from the Advanced Medical Technology Association (AdvaMed) advises. Read More
Verily Life Sciences’ investigational smartwatch has shown potential for monitoring Parkinson’s disease in home settings in a multiyear European study. Read More
A proposed in vitro clinical test (IVCT) reform bill that may end up in the fifth iteration of the Medical Device User Fee Act (MDUFA) is generating pushback from industry groups and academia. Read More
The FDA smacked Louisville, Ky.-based devicemaker Vivorte with a Form 483 over sterilization lapses observed during an inspection conducted from Nov. 15 to 23, 2021. Read More
In observance of the Memorial Day holiday, FDAnews Device Daily Bulletin Premium will not be published Monday, May 30. The next issue will be published Tuesday, May 31. Read More
Ethicon, a Johnson & Johnson medtech company, has lost its appeal of a patent claim it filed against Intuitive Surgical over an endoscopic surgical stapling device. Read More