Endotronix files a PMA for the Cordella Pulmonary Artery (PA) Sensor System, a heart failure patient management platform for home monitoring.
Insulet Corp. recalls its Omnipod 5 smartphone application and software that is used to control an insulin pump due to an error in the bolus calculato...
FDA authorizes Floridas importation program that will allow drugs to be imported from Canada as long as certain conditions are met.
FDA clears a Nanowear 510(k) for the companys SimpleSense, a nanotechnology-enabled wearable and software platform.
FDA approves Novartis Radioligand Therapy manufacturing facility in Indianapolis, IN, to produce prostate cancer therapy Pluvicto.
FDA leaders say anti-vaxxers and those that are vaccine-hesitant due to safety concerns or religious beliefs are threatening U.S. public health by ris...
FDA issues ModernaTX a five-item Form FDA-483 after a 09/11-21/2023 inspection documented GMP violations.
