Becton, Dickinson and Co. (BD) has decided to spin off its diabetes care business, after nearly a century growing a broad portfolio of insulin injection devices. The transaction, which will result in a publicly traded company, tentatively dubbed Newco, is expected to be completed in the first half of 2022. Read More
The COVID-19 pandemic’s impact on inspections of drug and device manufacturing sites is a matter of record, but the agency says it is on track to resume inspections for high-risk considerations. However, the FDA also said it will likely make more extensive use of virtual inspection tools going forward, a development that may ease some of the operational interruptions engendered by conventional on-site inspections. Read More
HONG KONG – The revisions for China’s Regulations for Supervision and Administration of Medical Devices, which promise harsher penalties and post-market enforcements, will come into effect on June 1, 2021. The revisions see authorities take a more progressive and aggressive approach to the regulatory enforcement of medical device products in China. Read More
LONDON – Cumulus Neuroscience Ltd. has raised £6 million (US$8.3 million) to advance development of its home use wearable headset for tracking response to treatment in clinical trials in psychiatric disorders and neurodegenerative diseases, including Alzheimer’s. Read More
Across the world, rates of depression have reached alarming new heights as a result of the grief, uncertainty and isolation experienced through the pandemic. Despite the high prevalence of depression, its treatment remains a hit-or-miss affair. Up to two-thirds of patients fail to respond to the first antidepressant prescribed and many of them never return to try another. Tel Aviv-based Taliaz Ltd. has developed an artificial intelligence-driven tool to help psychiatrists and other prescribers get it right the first time. Read More
Although it has been a strong year for med-tech financings, they appear to be losing ground. While the first three months of 2021 showed a 67% increase in money raised over the same time frame in 2020, it is now showing that financing values are up by only 15% in comparison to last year. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aegis Spine, Appriss Health, Auxo Medical, Biointellisense, Cleardata, Cryoport, Labconnect, Life Spine, Patientping, Triumvira Immunologics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medo AI. Read More
