Clinical trials are subject to US federal regulations under the Food and Drug Administration (FDA).FDA oversight regulationsare designed to protect the rights and safety of trial participants, and cover how clinical trials are designed, conducted, analyzed, and reported. You can find...
The Multiclinical Trial Web PACS (MCTWP) is a free software platform to support image management in clinical trials. This means not only long-term image storage, but also trial protocol support, post-processing, task management and result registration. The application makes it possible to ensure...
Through the trial, Dr. Sweetman is aiming to develop the pathway within the doctors' central software program, to help GPs identify and refer patients to the specialized digital cognitive behavioral therapy program for insomnia. Researcher Dr. Alexander Sweetman in the sleep lab at the Adelaide I...
Regulatory Hurdles and Ethical Concerns in FDA Oversight of AI/ML Medical Devices Alana Hippensteele, Managing Editor October 15th 2024 The FDA faces a multitude of challenges in regulating artificial intelligence (AI) and machine learning (ML) medical devices. ...
“There is strong evidence that combining physical activity, healthy nutrition, social experiences, intellectual challenges, and improved self-management of medical conditions can protect cognitive function in older adults who are at increased risk for cognitive decline.” Tip: Call the Alzheimer's ...
Fixed hemimandibles were scanned using a cone beam-type tomograph (SCANCO Medical μCT 100, SCANCO Medical AG, Switzerland).65,66 To quantify the periradicular bone resorption area, a region of interest (ROI) was drawn around the root and apical foramen, starting from the first transaxial cu...
One solution for funding clinical trials outside of a biopharma’s P&L is to spin assets out into new VC-backed entities. In this model, the biopharma company typically holds equity in the newly formed company in exchange for the assets. This model alleviates clinical risk for the biopharma...
Notably, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) endorsed the recommendation that for medical tests that “have a central role in the decision-making of a specific disease and where cutoff/decision limits are established,” assay specifications should be based on ...
Trial registration number Current Controlled Trials ISRCTN47267892 – A randomized controlled trial in primary care of a novel method of using preformed metal crowns to manage decay in primary molar teeth: the Hall technique.Peer Review reports Back...
[0033] It should be understood that the present invention is preferably implemented in software of a microprocessor controlled implantable medical device and its cooperating programmer device. Suitable implantable devices include, but are not limited to commercial pacemaker products sold under the Talent...