The U.S. FDA reported that Baxter International Inc. issued an Urgent Medical Device Correction for its Life2000 ventilation systems in response to reports of potential patient oxygen desaturation events when connected to a third-party oxygen concentrator.
Venus Medtech (Hangzhou) Inc. completed the enrollment of patients for a confirmatory clinical trial using its Liwen RF ablation system for the treatment of hypertrophic cardiomyopathy (HCM), reaching 128 patients in 20 hospitals in mainland China since January 2021.
A new blood test developed by Durin Technologies Inc. and Rowan-Virtua School of Osteopathic Medicine detected the presence of Alzheimer’s disease pathology in nearly all asymptomatic patients who went on to developed cognitive impairment or dementia, a study in the Journal of Alzheimer’s Disease found. The test uses eight autoantibody biomarkers to identify patients with the disease at pre-symptomatic, prodromal and mild-moderate stages of disease.
Doctorly GmbH raised $10 million in a series A funding round to revamp the German health care sector, giving medical staff new tools to eliminate disk operating systems (DOS).
Vivasure Medical Ltd. received a €30 million (US$32 million) strategic investment from Haemonetics Corp. to help develop its Perqseal closure device system which manages bleeding complications associated with large-bore arterial vessel closure. Haemonetics has an option to buy Vivasure upon the completion of the company achieving certain milestones.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cathera, Visby Medical.
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