A more than three-year commercial hold built up an estimated $1 billion in demand for Becton, Dickinson and Co.’s (BD) Alaris infusion system and BD has every intention of meeting that demand as quickly as possible now that it has FDA clearance for the updated device. The clearance allows the company to resume commercial sales and undertake remediation of its installed base of point-of-care units with enhanced features for its pumps and monitoring systems as well as new software and upgraded cybersecurity and interoperability. Read More
As quicker, more accurate ways to detect dementia becomes ever more urgent, Cumulus Neuroscience Ltd. has teamed up with the Universities of Bath and Bristol in the U.K. to further develop the Fastball electroencephalogram (EEG) test, a diagnostic test for earlier detection of Alzheimer’s dementia. With one in three people born in the U.K. today likely to develop dementia at some point in their lives, early diagnosis and treatment are essential for them to plan for their future. Read More
Physicians and device manufacturers don’t always see things the same way, but there are large areas of overlap, such as the impact of prior authorization and the effects of certificates of need for radiology facilities. These two issues came up in a hearing of the House Small Business Committee, suggesting that legislation may be forthcoming that would tackle these and other issues that hamper both the practice of medicine and sales of medical devices. Read More
Mediwhale Inc. and Yonsei University College of Medicine, Seoul, Republic of Korea, are developing a new predicting tool combining artificial intelligence (AI) and non-invasive retinal eye examination capable of accurately predicting chronic kidney diseases before symptoms appears. Read More
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aethlon, Biocardia, Blueriver Acquisition, Dante Genomics, EDP Biotech, Epigenomics, J&J, Kova International, LGC Clinical Diagnostics, Nectero Medical, New Day Diagnostics, Somalogic, Spinal Stabilization, Talis Biomedical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nesa Medtech. Read More
