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    Regulatory Approvals

    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...

    ABM Respiratory Care receives CE Mark Certification for BiWaze® Cough

    ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced it has received...

    CurvaFix’s smaller-diameter IM Implant secures FDA 510(k) clearance

    The CurvaFix IM Implant follows the natural curvature of a patient’s bone shape and fills the space in the pelvis. CurvaFix has obtained 510(k) clearance for its...

    US FDA grants pre-market approval for Abiomed’s Impella RP Flex

    The Impella RP Flex is indicated to provide temporary right ventricular support for up to 14 days. The US Food and Drug Administration (FDA) has granted pre-market...

    Radiaction Medical Announces the Latest Food and Drug Administration 510(k) Clearance for its Novel, Automated Radiation Shield System, Highlighting U.S. Expansion

    Radiaction Medical, Ltd. ("Radiaction"), a medical device innovator dedicated to providing healthcare physicians and staff with effective radiation protection during interventional procedures, announced it...

    FDA grants 510(k) clearance for NeuroOne’s Evo sEEG Electrode technology

    The FDA clearance will enable NeuroOne to market its Evo sEEG System for temporary use of less than 30 days. The US Food and Drug...

    FDA grants 510(k) clearance for DePuy Synthes’ TELIGEN System

    As against current MIS technologies, the TELIGEN System could be efficient and cost-effective for hospitals. The US Food and Drug Administration (FDA) has granted 510(k) clearance for DePuy...

    Sinaptica Therapeutics obtains FDA Breakthrough Device Designation for Alzheimer’s treatment

    The neurostimulation device, which is currently for investigational use only, aims to treat cognitive and functional decline in Alzheimer's patients. Cambridge-based Sinaptica Therapeutics, a company...
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