As cases skyrocket and more questions arise about the high rate of false negatives returned by rapid testing in COVID-19 cases, a simple, new diagnostic test offers far greater accuracy. Researchers around the globe have found that artificial intelligence can detect coronavirus infections in recorded forced coughs, with nearly 100% accuracy in asymptomatic or presymptomatic cases, making it an ideal quick screening test. Forced cough or voice analysis shows strong results in other conditions, too, including pulmonary hypertension and, surprisingly, Alzheimer's disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocartis, Icotec, Materialise, Medcad.
The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medicine, Nightware, Nuvasive.
Keeping you up to date on recent developments in cardiology, including: What is causing COVID-19 blood clots?; Using machine learning to predict survival rates with OHCA; Remote cardiac rehabilitation proves itself.
Keeping you up to date on recent developments in neurology, including: AI helps detect brain aneurysms on CT angiography; BBB studies advancing focused ultrasound treatment for Parkinson’s; Study reveals unexpected protective role for brain swelling after injury.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE reviews Dexcom’s G6; Ortho claims EUA for antigen test with 100% sensitivity.
PARIS – Oncomfort SA has entered a partnership with Vygon SA for distribution of its Sedakit in six countries in Europe. The synergy between Vygon’s specialization and Oncomfort’s fields of application aims to enable greater acceleration of the adoption of Digital Sedation by health care professionals and patients. “Thanks to this strategic partnership, our new technology for relieving patient pain and anxiety without medication is going to be widely available in Europe,” Mario Huyghe, CEO of Oncomfort, told BioWorld.
LONDON – The U.K.’s influential health technology assessment body, the National Institute of Health and Care Excellence (NICE), is consulting stakeholders on proposed changes to how it selects medical devices, diagnostics and drugs for evaluation.