A point risk score prediction model that can identify an individual’s risk of developing dementia at 13 years has been developed by researchers in China using diagnostic study data involving 444,695 individuals in the UK. The tool was able to determine 13-year risk for dementia with almost 100% accuracy for both men and women.
Biomedical devices, such as a drug delivery tool, staples and stents made out of aluminum that dissolve within minutes when exposed to eutectic gallium-indium were developed by a team led by a Mechanical Engineering Assistant Professor at MIT. Researchers noted that further studies are needed to verify the technique’s safety in human applications.
An algorithm that works with a built-in accelerometer in a smart watch to track a user’s gait quality, Watch Walk, has been developed by researchers at the University of New South Wales and Neuroscience Research Australia. The tool measures walking-related factors, such as stride length, cadence, posture and speed, which can aid in determining an individual’s risk of falling.
The FDA has released two final guidances related to medical device post-market surveillance and procedures for handling post-approval studies. The procedures guidance offers recommendations on PAS content and format as a condition of premarket approval, while the surveillance guidance explains the Agency’s interpretation of post-market surveillance orders for certain Class II or Class III devices according to section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The Echoes app, which turns a smartphone into a standard stethoscope when placed on a user’s skin, shows promise in monitoring the progress of heart conditions, a study shows. “The results have shown that non-medical users are able to record heart sounds in sufficiently good quality for further processing of the signals. We may be able to extract further features for diagnosis and monitoring purposes in future clinical studies,” said study Author Hongxing Luo.
A study published in JAMA Network Open revealed that the Childhood Asthma Risk Tool outperformed the Asthma Predictive Index, which requires invasive tests, as well as diagnoses by physicians.
An artificial intelligence-guided system that uses retinal scans to determine if an individual is likely to experience stroke or heart disease was developed by researchers in the UK. The fully automated tool, called QUARTZ, or QUantitative Analysis of Retinal vessels Topology and siZe, can produce 10-year risk scores.
Rescue Biomedical has received a $2.8 million Fast-Track Small Business Innovation Research grant from the National Institutes of Health to further the development of its implant to aid patients with opioid use disorder. The subcutaneous, minimally invasive device delivers naloxone when it detects opioid overdose in the user.
A study conducted by Seoul National University Bundang Hospital researchers found the Spine MT spinal decompression treatment tool was an effective option for patients with spinal disc diseases.
Final FDA guidance on regulating Clinical Decision Support (CDS) software as a medical device deviates from draft guidance issued in 2019. CDS software that is designed to acquire or analyze medical images or signals from diagnostic devices may be subject to regulation as a device; however, software designed for other purposes that meets three other criteria may be exempt.