We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
It’s possible to detect the potentially stroke-inducing cardiac condition atrial fibrillation effectively and more cheaply using wearable devices, according to researchers at Harvard Medical School and Massachusetts General Hospital. Read More
Omaha, Neb.-based medical imaging software company Bot Image has received FDA clearance for its ProstatID tool, a cloud-based artificial intelligence (AI) software product that helps detect and diagnose prostate cancer. Read More
Recalls can be messy, complicated matters, especially for manufacturers that don’t have a plan in place for analyzing a problem, determining a course of action and carrying out all recall-related tasks in compliance with FDA requirements. Read More
Cognito Therapeutics’ gamma sensory stimulation therapy reduced white matter atrophy in the brains of patients with Alzheimer’s disease in a six-month study, the company announced at the Alzheimer’s Association International Conference 2022 in San Diego. Read More
When evaluating adverse event reports, companies need to consider whether the reported effects in any given category can be prevented, managed or mitigated through reasonably available means. Read More
Janet Woodcock, principal deputy FDA commissioner, made clear the dire situation her agency will be in if user fees aren’t rapidly reauthorized and the FDA doesn’t receive new money from Congress to update its flagging IT infrastructure. Read More
As the EU’s 2017 Medical Device Regulation (MDR) comes fully into force, devicemakers need to keep track of significant changes in the form of “implementing and delegated acts,” according to one UK-based regulatory expert. Read More
Smiths Medical has issued an urgent medical device correction letter about a potential risk associated with pressure chambers used with the company’s Level 1 Fast Flow Fluid Warmers, which deliver solutions or warmed blood to patients. Read More