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Medical students and faculty at the University of Florida, along with one high school student, have released an app that can measure the battery life in deep brain stimulation devices. Read More
Innovations in diagnostic medicine have allowed rapid progress against malaria, tuberculosis and other infectious diseases, and enabled testing of patients in remote, underserved regions of the world, experts from the Centers for Disease Control and Prevention say. Read More
Devicemakers testing the Wi-Fi functionality of their products should simulate the radio frequency (RF) characteristics of a hospital and should use access points from different manufacturers, a recent white paper from Laird Technologies recommends. Read More
Valencia, Calif.-based SetPoint Medical has hired Sagentia to develop a programming interface for a neuromodulation device designed to provide a lower-cost and lower-risk alternative to immunosuppressive drugs such as prednisone that treat chronic inflammatory diseases such as Crohn’s disease and rheumatoid arthritis. Read More
Devicemakers seeking regulatory approval in the U.S. are strongly urged to blind patients and investigators in pivotal clinical trials, when possible, according to final guidance issued by the Food and Drug Administration. Read More
Medtech sponsors should balance the need to demonstrate safety and efficacy with the potential risks to patients when determining the size and duration of a clinical trial, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
In the latest effort to clean up India’s troubled clinical trial industry, the government is requiring that clinical investigators video record the informed consent process with each study subject. Read More
Advisors to Ministry of Health and Family Welfare are calling for reforms to address weaknesses in India’s clinical investigation and medical products approval processes. Read More
In vitro diagnostics products meant for research or investigational use used commercially without appropriate approvals may be considered adulterated and misbranded, an FDA final guidance says. Read More