Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic ...

Abstract: The Verification and Validation (V&V) processes are used to determine whether the development products of a given activity conform to the requirements of that activity and whether the ...

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

This course offers a strategic edge by refining cloud system classification through CSA principles, preventing compliance pitfalls and inefficiencies. It empowers teams to enhance validation precision ...

Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...

This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...

Abstract: Hyperspectral imaging (HSI) is a powerful image technique that allows capturing spatial and spectral information, being able to characterize materials, tissues, and elements in a noninvasive ...

The Volt PFA system. [Image courtesy of Abbott] Abbott (NYSE: ABT) + announced today that the FDA approved its Volt pulsed field ablation (PFA) system to treat patients with AFib. Abbott said it plans ...

Dr. Céline Gounder, an internist, epidemiologist and infectious disease specialist, is a CBS News medical contributor as well as senior fellow and editor-at-large for public health at KFF Health News.

The U.S. Food and Drug Administration has granted 510(k) clearance to 3D Systems, allowing its VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform to benefit a ...

BGB-B2033 is a bispecific antibody directed at GPC3 and 4-1BB; key targets in the most common liver cancer FDA Fast Track Designation reflects the potential of BGB-B2033 in an area of high unmet need ...

Johnson & Johnson has secured an expanded indication from FDA for its TRUFILL n‑BCA Liquid Embolic System for embolization of the middle meningeal artery for the treatment of symptomatic subacute and ...