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.
The company is launching a kit that includes the device and a tablet computer that is pre-configured for access to the cloud-based VirtualCare telemedicine platform. Read More
The FDA has also granted Enhertu an accelerated approval for treatment of this specific NSCLC patient population who have received a prior systemic therapy. Read More
A new DNA sequencing test that detects extra or missing fetal chromosomes has results comparable to standard clinical tests, is less expensive and can be done at the point of care in one day, according to a study led by researchers at New York’s Columbia University.
The FDA said it has received 44 more reports of deaths associated with the June 2021 recall of millions of Philips’s continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices.
When it comes to blood pressure monitoring at home, old-fashioned blood pressure cuffs work just as well as newer, app-based technology, researchers reported in the journal JAMA Internal Medicine. Read More
Sunnyvale, Calif.-based molecular diagnostics company Cepheid is embroiled in a controversy over access in developing countries to its tuberculosis diagnostics test, which was funded in part by the World Health Organization (WHO). Read More
The FDA has updated its guidance for manufacturers of in vitro diagnostic devices who want to use a previously cleared instrument assay, or replacement reagent, on another instrument, providing information on when and how to determine if a new 510(k) application is needed. Read More
Manufacturers should provide better information about specific risks and directions for use of hydrogen peroxide-based contact lens care products (HPCPs), the FDA said in a draft guidance released yesterday. Read More