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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
Washington, D.C.-based MedStar Health has signed a deal licensing to InnoVital Systems the intellectual property rights to the artificial muscle technology that it hopes will power the InVent diaphragm assist device. Read More
Sitoa Global and the University of California San Francisco have signed a letter of intent to negotiate an option agreement for the license of a stereotactic device to deliver stem cells directly into the brain. Read More
The China Food and Drug Administration has published a list of roughly 130 Class II devices that are exempt from submitting clinical trial data. Read More
Medical devicemakers should avoid recruiting and putting at risk an unnecessarily large number of patients in clinical trials, the UK’s Medicines and Healthcare products Regulatory Agency says in one of five trial-related guidances issued last month. Read More
Makers of in vitro diagnostics meant for research or investigational use only should take care not to encourage commercial use of their products. Read More