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.
The FDA has published a landmark final rule that creates a new category of over-the-counter (OTC) hearing aids aimed at improving access and lowering the cost of the devices. Read More
Becton Dickinson will co-market Accelerate Diagnostics’ rapid tests for antibiotic resistance and susceptibility under an agreement the companies announced yesterday. Read More
The UK’s National Institute for Health and Care Excellence (NICE) is inviting comments on its first draft recommendation for a diagnostic device — AliveCor’s KardiaMobile 6L heart monitor — under a new fast-track review program called the Early Value Assessment pilot project. Read More
The UK’s Department of Health and Social Care is seeking information for an independent review of the potential ethnic bias of certain medical devices such as oximeters and infrared scanners. Read More
Long-term results from the clinical study that supported the FDA’s approval of Channel Medsystems’ Cerene Cryotherapy system show that the device continued its steady reduction of heavy menstrual bleeding after three years. Read More
Two device companies that share the same address in Natick, Mass., have received separate warning letters from the FDA for quality system failures observed during an FDA inspection, including not fully investigating complaints and a lack of adequate corrective and preventive actions (CAPA). Read More
The initial response to the FDA’s trial opening of its Customer Collaboration Portal to premarket device submissions has been encouraging, the agency says. Read More
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
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
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