FDA clears an Implicity 510(k) for its algorithm SignalHF used in its remote monitoring for heart failure.
Representatives Raul Ruiz (D-CA) and Larry Bucshon (R-IN) introduce bipartisan legislation to improve participation in clinical trials by underreprese...
FDA clears a Brainomix 510(k) for its Brainomix 360 e-Lung for lung imaging.
FDA grants Notal Vision a de novo authorization for its patient self-operated SCANLY Home optical coherence tomography device.
Federal Register notice: FDA announces the issuance of a priority review voucher to X4 Pharmaceuticals in response to gaining approval of a rare pedia...
FDA qualifies the Assessment of IntraOcular Lens Implant Symptoms patient-reported instrument as a medical device development tool.
Lilly says its once-weekly insulin efsitora alfa met endpoints in two trials with insulin-nave adults with Type 2 diabetes.
FDA updates a Draeger Class 1 recall (device correction) of the Perseus A500 anesthesia workstation after receiving reports that the internal backup b...
