The US Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials.

The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce ...

Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of ...

Early implementation of real-time clinical trial data sharing aims to reduce delays in safety signal detection and regulatory ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s ...

SAN ANTONIO--(BUSINESS WIRE)--AirStrip®, a leader in advanced clinical monitoring and alarm management solutions, has announced the acquisition of DECISIO® Health, a provider of innovative clinical ...

Once diagnosed, age-related macular degeneration (AMD) needs to be regularly monitored for progression both before treatment or rehabilitation is initiated (to guide the initiation decision) and ...

Clinical trial monitoring and quality assurance are pivotal elements in the successful conduct of clinical research. These processes ensure that trials adhere to regulatory requirements, maintain high ...

Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...

Joe Kiani, Founder and CEO of Masimo, said, “We are grateful for the opportunity to collaborate with world-class organizations like UCHealth. By combining our technological expertise and their ...

Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters ® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable ...