3M launches new adhesive tape with 28-day wear time: 3M has released Medical Tape 4578, its new medical adhesive that has liner-free stability and can be worn on the skin for up to 28 days. The tool can also be stored for up to a year.
Artificial Intelligence (AI) predicts autism risk in bases based on Electronic Health Record (HER) data: Researchers used EHR data from 45,080 babies up to a year old to train an autism prediction model that achieved high sensitivity, specificity and positive predictive value, according to a study published in JAMA Network Open. The algorithm “could be integrated with caregiver surveys to improve the accuracy of early autism screening,” researchers wrote.
Smartphone app might detect onset of stroke: A smartphone machine learning algorithm called FAST AI detects facial asymmetry, arm weakness and speech changes associated with the onset of a stroke. Studies of FAST AI conducted at four stroke centers in Bulgaria found the app was accurate, but some experts say false negatives could be dangerous, and the technology should be used to prompt users to seek medical attention quickly, not to rule out a stroke.
Machine-learning method offers view of placental compartments: A machine-learning method for automated MRI scan processing has been developed by NIH-funded researchers to provide a detailed view of compartments in the placenta, including intervillous space and placental tissue and vessels. The technique is being studied for the potential to aid in early monitoring of placental health to identification and prevention of complications in pregnancy.
Immunexpress tool can flag COVID-19 patients needing hospitalization: A study that assessed SeptiCyte RAPID from Immunexpress has validated the test as a triaging tool to identify disease severity and predict hospitalization or Intensive Care Unit (ICU) care needs of patients with COVID-19. The tool was able to identify critical and severe patients when used within 48 hours of intake.
FDA awarded fewer breakthrough device tags in 2022: The annual report from the FDA’s Center for Devices and Radiological Health (CDRH) shows a nearly 37% drop in devices awarded breakthrough designations. Medical devices awarded breakthrough tags dropped to 135 from 213 in 2021, while devices with breakthrough status that were given marketing authorization increased from 13 to 19.
FDA Emergency Use Authorizations (EUAs) will continue even if Public Health Emergency (PHE) ends: The FDA said the expected end of the COVID-19 public health emergency declaration in May 2023 will not have any impact on the Agency’s ability to grant Emergency Use Authorizations. In a Twitter post in early February 2023, the Agency said that “existing Emergency Use Authorizations (EUAs) for products will remain in effect and the Agency may continue to issue new EUAs going forward when criteria for issuance are met.”
Gamification might encourage men to use diabetes prevention app: Women and people with obesity were more likely than men and people with a lower BMI to use the Waya diabetes prevention app, according to a study published in Cardiovascular Endocrinology & Metabolism. The app is designed to help people manage diabetes risk factors through exercise, diet and lifestyle modifications, and researchers said adding gamification (gaming-like) features might make the app more attractive to men.
Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) using AI to fight fraud: The CMS is using tree-based artificial intelligence models and deep learning approaches in a pilot program to identify fraudulent Medicare claims, HHS Chief Information Officer Karl Mathias says. At the FDA, computer vision AI is being put to use to detect counterfeit drugs within seconds, and the NIH is using AI to audit research proposals, Mathias says.
Smartphone health app developers investing in clinical studies: Advances in technology are slowly turning smartphones into medical devices that measure signs of health and transmit data to clinicians; however, the accuracy and clinical utility of most health-related smartphone tools and apps still must be validated, says Eugene Yang of the University of Washington. Technology that has not been validated against approved medical devices can yield false positives and negatives that drive health spending higher, so some developers have been investing in clinical trials.