In-Vitro Diagnostics
Feb 13, 2025
Agiliti Launches Essentia; KUBTEC Introduces PICASSO Plus; FDA Clears Neuvotion’s NeuStim™ for Non-Invasive Hand Stimulation in Stroke & SCI Patients; Ibex Medical Analytics Achieves Milestone with FDA 510(k) Clearance; BlueWind Medical Reports Strong Two-Year Outcomes for Revi® System in Peer-Reviewed Study; Reprieve Cardiovascular’s FASTR Pilot Trial Shows Positive Outcomes, FDA Approves IDE for Next Phase
Agiliti Launched Essentia, an Innovative Multi-Acuity Hospital Bed that Helps Lower Patient Risk and Accelerate Mobility On February 11, 2025, Agiliti, a prominent manufacturer and provider of medical device solutions for the U.S. healthcare industry, introduced Essentia™, a versatile multi-acuity bed fram...
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Nov 09, 2023
SIBIONICS’s Ground-breaking GS1 Continuous Glucose Monitoring System; Abbott’s HPV Test to Run on Alinity m; CleanNA’s CE-IVD Molecular Diagnostics Product; Orthofix’s WaveForm L Interbody System; Alucent Biomedical’s AlucentNVS Technology; Surmodics’s TRANSCEND Trial Data
SIBIONICS Received CE Mark for Its Ground-breaking GS1 Continuous Glucose Monitoring System On November 01, 2023, SIBIONICS, the world's third-largest Continuous Glucose Monitoring System (CGM) brand, received the CE Mark for its revolutionary GS1 CGM. This significant milestone marks a momentous achiev...
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Jun 01, 2023
THINK Surgical’s TMINI Miniature Robotic System; Cepheid’s Xpert NPM1 Mutation Test; Anika’s Hyalofast® US Pivotal Phase III Study; EMVision’s Portable Brain Scanner Trial; HeartBeam and Samsung’s Strategic Alliance Agreement; Eosolutions’s Dr. Banner Balloon Guide Catheter
TMINI Miniature Robotic System by THINK Surgical Received FDA 510(k) Clearance On May 30, 2023, THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TMINI™ Miniature Robotic System. A wireless r...
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Apr 06, 2023
Laborie Launched alpHaONE; Cadwell Launched Arc Voyager; Endotronix’s PROACTIVE-HF Pivotal Trial; Sonex Health’s Office-based Carpal Tunnel Release System with Ultrasound Guidance; Leica Biosystems’s BOND MMR Antibody Panel; Abbott Received FDA Approval for Epic™ Max Tissue Valve
Sonex Health Announced US Clinical Study to Report Safety and Effectiveness of Office-based Carpal Tunnel Release System with Ultrasound Guidance On March 30 2023, Sonex Health, Inc., a leader in innovative ultrasound guided therapies to treat common orthopaedic conditions and The Institute of Advanced Ult...
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Feb 24, 2022
Motus GI’s Pure-Vu EVS System; EvoEndo’s Single-Use Unsedated TNE System; Orthofix’s OpusTM BA; Invitae’s CE-IVD Cancer Testing Kits; PolyActiva’s PA5108 Ocular Implant; Ra Medical’s DABRA excimer laser system
US FDA grants 510(k) clearance to Motus GI’s Pure-Vu EVS System On February 15, 2022, The Pure-Vu® EVS System received 510(k) clearance from the US Food and Drug Administration, according to Motus GI Holdings, Inc., a medical technology company that provides endoscopy solutions that improve clinical outcomes and...
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