Tagged fda-clearance

Freyja Healthcare Secures $8M in New Funding and Appoints Tracy MacNeal as Independent Board Director
Press Release

Freyja Healthcare Secures $8M in New Funding and Appoints Tracy MacNeal as Independent Board Director

 Fresh financing to continue development of robust product portfolio and accelerate commercialization of Freyja’s VereSee Device to further innovation in fast-growing women’s health market Read More
Freyja HealthCare's VereSee™ Device Receives 510(k) Clearance, the First of Many Products
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Freyja HealthCare's VereSee™ Device Receives 510(k) Clearance, the First of Many Products

 Freyja Healthcare Brings First-of-Its-Kind 2mm Abdominal-Access Device to Laparoscopic Surgery to Further Innovation in Fast-Growing Women’s Health Market Read More
First Light Diagnostics Receives FDA Clearance for its Rapid B. anthracis Toxin Test on the MultiPath Analyzer
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First Light Diagnostics Receives FDA Clearance for its Rapid B. anthracis Toxin Test on the MultiPath Analyzer

 Rapid, sensitive test for the early diagnosis of inhalation anthrax Read More
Curiteva Announces FDA Clearance of Pedicle & SI Navigation Instrument System
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Curiteva Announces FDA Clearance of Pedicle & SI Navigation Instrument System

 Curiteva® Continues to Innovate by Adding a Navigation Instrument System to Complement Its Prodigy® Pedicle Screw System and SI-LUTION® Sacroiliac Joint Fusion Systems Read More
Curiteva Inc. Announces FDA 510(k) Clearance for Inspire 3D Porous PEEK HAFUSE Cervical Interbody System
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Curiteva Inc. Announces FDA 510(k) Clearance for Inspire 3D Porous PEEK HAFUSE Cervical Interbody System

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FDA Clears 'Selux NGP System' for Rapid Antibiotic Susceptibility Testing
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FDA Clears 'Selux NGP System' for Rapid Antibiotic Susceptibility Testing

 In vitro antimicrobial resistance test enables clinical labs to deliver targeted therapeutic results days faster than the current standard of care, clearing the path for personalized antibiotic therapies Read More
SoftWave Tissue Regeneration Technologies Receives FDA Clearance for Blood Circulation Increase, Minor Aches and Pains Relief and Connective Tissue Activation
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SoftWave Tissue Regeneration Technologies Receives FDA Clearance for Blood Circulation Increase, Minor Aches and Pains Relief and Connective Tissue Activation

 Extracorporeal shock wave device offers healthcare professionals another treatment option Read More
NGMedical GmbH Receives FDA Clearance for Its BEE® HA Cervical Cage System Made From PEEK-OPTIMATM HA Enhanced
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NGMedical GmbH Receives FDA Clearance for Its BEE® HA Cervical Cage System Made From PEEK-OPTIMATM HA Enhanced

 BEE® HA was developed to optimize fusion, while maintaining elasticity that is similar to bone and radiolucency of the cage body. Read More
NGMedical GmbH Receives FDA Clearance for Its AM Titanium Cervical Interbody BEE®
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NGMedical GmbH Receives FDA Clearance for Its AM Titanium Cervical Interbody BEE®

 NGMedical achieves milestone with first FDA clearance for its innovative spinal implants. Read More
Atreon Orthopedics Received FDA Clearance for Rotator Cuff Regeneration Product
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Atreon Orthopedics Received FDA Clearance for Rotator Cuff Regeneration Product

 RotiumTM, a Rotator Cuff Repair Device, Set to be Available April 1 Read More
FDA Clears Xavant Technology's Stimpod NMS460 Non-Invasive Neuromodulation Device for Treatment of Chronic Intractable Pain
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FDA Clears Xavant Technology's Stimpod NMS460 Non-Invasive Neuromodulation Device for Treatment of Chronic Intractable Pain

 The Stimpod NMS460 is a new neuromodulation device that offers hope where drugs fail in the treatment of chronic pain. Read More