The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment. Read More
Carmat SA recently reported a software update for its bioprosthetic total artificial heart Aeson device that will significantly improve its safety profile. In the past, the company had to suspend implantations of its device following issues around quality. With the enhancements, the Aeson software will be able to detect signals of malfunctions in real time and adapt the control of the prosthesis so that its performance is not affected. Read More
Six months out from the World Health Organization ending the global health emergency brought on by the pandemic, there’s no need for the World Trade Organization to expand a five-year intellectual property (IP) waiver for vaccines to COVID-19-related drugs, devices and diagnostics. Read More
The U.S. Office of Inspector General (OIG) reported that it and Philips Respironics have come to terms over allegations that the company violated the False Claims Act (FCA) by offering free CPAP masks to operators of sleep clinics Read More
Ubidx Inc. has designed a diagnostic system comprised of a fluidic single-use disposable and a base. While the fluidic single-use disposable or cartridge is generally described as being suitable for testing a single sample, the base or hub may be used numerous times to perform numerous tests using numerous fluidic single-use disposables or cartridges. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angle, Better Therapeutics, Daxor, Endoquest Robotics, Lumiradx, Pulse Biosciences, Roche, Simbiosys. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CGBio, Endosound, Pulnovo. Read More
