FDA cannot accept new 2019 user fees during the government shutdown, which means the agency cannot accept new medical product applications.
The collaboration will use the Apple Watch to measure the outcomes of J&J’s heart health engagement program.
The acquisition comes hot on the heels of Boston Scientific making a significant acquisition into the mitral valve space.
The Irvine, CA-based company is slated to pay out $180 million to Boston Scientific in a move that would end both firms’ outstanding TAVR lawsuits and injunctions.
Abbott says its Amplatzer Piccolo Occluder is the first device approved for use in the tiniest babies (weighing as little as two pounds) to treat patent ductus arteriosus, a common congenital defect.
The Palo Alto, CA-based company will collaborate with Magic Leap, a specialist in augmented reality and spatial computer technology to bring its technology to an AR platform.
ARGONet is an AI solution developed by researchers from the Computational Health Informatics Program at Boston Children’s Hospital, and results evaluating the method's effectiveness were published in Nature Communications.
An artificial intelligence solution that can identify precancerous changes in a woman’s cervix, comes on the heels of a Mayo Clinic Study that shows the percentage of women who are screened for cervical cancer could be far lower than national data suggests.
FDA has granted AWAK Technologies a breakthrough device designation for a wearable and ultra-portable peritoneal dialysis device.
Key changes include sections guiding education and marketing programs, communication on safe and effective use of medtech, and on providing technical support. The update also expands provisions on support for third-party educational and other conferences.
The magazine published a special January edition on "The Future of Medicine" highlighting innovative organs-on-chips research and technology.
The first donor-derived cell-free DNA test to assess allograft health in kidney transplant patients is also beneficial for repeat transplant recipients, a new study finds.