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    Regulatory Approvals

    AngioDynamics Submits 510(k) Application to FDA for AlphaVac Mechanical Thrombectomy System

    Thrombectomy Device with Off-Circuit Mechanical Aspiration Design for Treatment of Undesirable Intravascular Material in Venous System and Peripheral Vasculature.

    Chemence Medical’s redesigned skin closure system approved by FDA

    The US Food and Drug Administration (FDA) has granted 510(k) approval to Chemence Medical’s redesigned Exofin fusion skin closure system.

    Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis

    The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective...

    Digital X-ray company Nanox scores first FDA clearance

    The company's device promises to change the way medical imaging is used and make it much more widely available by cutting the...

    FDA grants Oxehealth Vital Signs De Novo clearance; Oxehealth launches in the US

    Vision-based patient monitoring and management company will focus on skilled nursing facilities, where its technology service can help clinicians deliver safer, higher...

    Caristo Diagnostics announces EU approval for AI technology that can predict heart attacks years in advance

    Research funded by us has led to EU-approved artificial intelligence (AI) technology that can identify people at high risk of a fatal...

    FDA Grants Breakthrough Device Designation to Tempus’ Atrial Fibrillation ECG Analysis Platform, Developed in Collaboration With Geisinger

    Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the...

    GE Healthcare Gains FDA Clearance of New 3D Surgical Imaging

    GE Healthcare was granted FDA 510(k) clearance to market OEC 3D, a new surgical imaging system capable of 3D and 2D imaging.

    Medtronic secures CE mark for directional lead system for deep brain stimulation

    Medtronic plc obtained the CE mark for its Sensight directional lead system for deep brain stimulation (DBS) for movement disorders and epilepsy, which...

    Latest articles

    Novocure Announces Update on Phase 3 Pivotal LUNAR Trial

    International oncology company, Novocure, has announced an update regarding its phase 3 pivotal LUNAR trial of Tumor Treating Fields (TTFields) in stage 4...

    OncoSec Receives CE Mark Certification for its Commercial Electroporation Device “GenPulse™” for the Treatment of Solid Tumors

    CE mark enables commercialization of GenPulse™ in EU OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company"...

    Endologix acquires PQ Bypass to expand vascular product portfolio

    Deerfield Management owned Endologix has acquired medical technology company PQ Bypass to bolster vascular reach to treat unmet medical needs of both...

    CeQur raises $115M for wearable insulin delivery device

    CeQur announced that it closed an oversubscribed equity financing round with proceeds of $115 million.
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