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    h2o therapeutics’ Parky app receives 510(k) clearance from US FDA

    The Parky app monitors tremor and dyskinesia symptoms of Parkinson's Disease patients in real time. h2o therapeutics has secured 510(k) clearance from the US Food and Drug...

    LivaNova LifeSparc ACS pump cleared for extended use

    LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane...

    FDA clears Neocis surgical robot for bone reduction

    Neocis announced that it received FDA 510(k) clearance for its Yomi surgical robot system for use in guided bone reduction. This represents the second FDA clearance...

    Chocolate Touch drug-coated angioplasty balloon for treatment of peripheral artery disease receives FDA approval

    Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter developed...

    Accelus Wins FDA 510(k) Clearance for Remi Robotic Navigation System Software Update

    Accelus has announced that the U.S. Food & Drug Administration (FDA) had cleared its 510(k) application for its Remi™ Robotic Navigation System software update...

    Caption Health Receives Regulatory Approvals for Caption AI™ Technology Platform in Canada and Australia

    Caption Health, the leader in using AI and services to improve access to heart ultrasound diagnostics, announced new regulatory approvals to market its Caption...

    Baebies Receives FDA 510(k) Clearance for G6PD Test on FINDER Platform

    Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. The test is run...

    ProciseDx Announces FDA Clearance of ProciseDx instrument and C Reactive Protein (CRP) Assay

    ProciseDx Inc. announces FDA clearance of its ProciseDx instrument and C reactive Protein (CRP) test. Procise CRP gives quantitative determination of CRP levels in patient serum...

    Exactech’s TriVerse primary knee system obtains FDA 510(k) clearance

    The TriVerse primary knee system aims to provide cruciate retaining along with anterior and posterior stabilised constructs. Exactech has obtained 510(k) clearance for its TriVerse primary knee replacement...

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