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Guardant Health gets EU IVDR certification for Guardant360 CDx blood test

Precision oncology company Guardant Health has received the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR 2017/746) for its Guardant360…

AiM Medical Robotics and BWH collaborate on DBS robot trial

AiM Medical Robotics has forged a collaboration with Brigham and Women's Hospital (BWH) and the Surgical Navigation and Robotics (SNR)…

AngioDynamics obtains CE Mark for AlphaVac F18⁸⁵ System to treat PE

Nasdaq-listed AngioDynamics has received the CE Mark approval in Europe for the AlphaVac F1885 System to treat pulmonary embolism (PE).…

DentalMonitoring gets FDA De Novo approval for remote monitoring software

DentalMonitoring has been granted De Novo approval by the US Food and Drug Administration (FDA) for its DentalMonitoring remote monitoring…

HeartBeam AI with VCG outperforms cardiologist panel in atrial flutter detection, says HeartBeam

HeartBeam said that its artificial intelligence (AI) algorithm HeartBeam AI and proprietary vectorcardiography (VCG) technology have outperformed an expert panel…

Laborie launches Solar Compact System and Solar AMC for gastrointestinal diagnostics

Laborie Medical Technologies has launched the Solar Compact System and Solar Anorectal Manometry Catheter (AMC) to improve diagnostics of gastrointestinal…

Meditrina secures FDA 510(k) approval for new-generation Aveta system

US-based women's health medical devices manufacturer Meditrina has received the US Food and Drug Administration (FDA) 510(k) approval for the…

Medtronic’s Affera system with Sphere-9 Catheter meets key endpoints in AFib trial

Medtronic said that its Affera Mapping and Ablation System with Sphere-9 Catheter has achieved the safety and efficacy endpoints in…

US FDA approves FX full-wedge augmented glenoid baseplates

US-based medical equipment manufacturer FX Shoulder Solutions has received the US Food and Drug Administration (FDA) 510k approval for its…

Roche secures FDA approval for its HPV self-collection solution

Swiss health technology company Roche has received the US Food and Drug Administration (FDA) approval for its human papillomavirus (HPV)…

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