The company’s 3rd FDA clearance accelerates the shift to AI-powered digital hematopathology, enhancing diagnostic speed and patient care
IRVING, Texas, April 16, 2024 /PRNewswire/ — Xstim, Inc., a pioneering developer and manufacturer of cutting-edge bone growth stimulation systems, is thrilled to announce its recent Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA) for Xstim™ Spine Fusion Stimulator
The 3D printed PEEK implants using the EXT 220 MED were successfully demonstrated in nearly 40 cranioplasties across Europe in recent months says the company.
Simpson Interventions announced this week that it received FDA breakthrough designation for its Acolyte image-guided crossing and re-entry catheter system.
The Food and Drug Administration (FDA) has approved the Investigational Device Exemption (IDE) of the Lumerah™ technology for the early detection of fetal distress during labor and delivery.
Onkos Surgical this week announced it received FDA de novo approval for its antibacterial coated implants.
Vivos Therapeutics specializes in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders (including all severities of obstructive sleep apnea (OSA) in adults).
Medical Microinstruments said the system could increase the number of physicians who can perform complicated microsurgical procedures.
Neurovalens announced today that it received FDA clearance for its Modius Stress device for treating anxiety and raised $2.65 million.
Orthobond has secured FDA de novo approval for its Ostaguard antibacterial technology that could one day be used for a wide range of medical devices — and beyond medtech.