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Around the Web: Stakeholders seek tweaks to FDA’s voluntary improvement program guidance
Stakeholders seek tweaks to FDA’s voluntary improvement program guidance Regulatory NewsRegulatory News | 08 July 2022 | By Jeff Craven 3044 The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to […]
Around the Web: Calidi Biotherapeutics Announces FDA Authorization of IND for a Phase 1 Clinical Trial of NeuroNova in Patients with Recurrent High-Grade Glioma
LA JOLLA, Calif.–(BUSINESS WIRE)– Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, is pleased to announce that City of Hope has received U.S. Food and Drug Administration (FDA) authorization to proceed with a phase 1 physician-sponsored clinical trial that will use Calidi’s licensed oncolytic […]
Around the Web: iRhythm receives FDA clearance for ZEUS System for Zio watch
iRhythm Technologies has received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. Produced in partnership with Verily, an Alphabet precision health company, the ZEUS System combines deep learned algorithms with a proven and trusted cardiac arrhythmia service. The ZEUS System is the AI algorithm and solution component of the […]