VERO Biotech’s Second Generation GENOSYL® Delivery System (DS) Receives FDA Approval in Anesthesia in the Surgical Suite

VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating room setting. Second generation GENOSYL®DS is now the first and only device for iNO…

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Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System

Axonics, Inc., a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20™ neurostimulator is labeled for a functional life in the body of at…

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Able Medical Announces Launch of Valkyrie® Looped Sternotomy Sutures

Able Medical Devices announced the launch of Valkyrie® Looped Sternotomy Sutures. The stainless-steel looped wire sutures are used to close a patient’s chest after open heart surgery. When compared to traditional wire sutures, the Valkyrie Looped Suture doubles the surface area of single wires and provides a more robust sternal closure. Valkyrie Looped Sternotomy Sutures…

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Medcura Receives Breakthrough Device Designation for its LifeGel™ Absorbable Surgical Hemostat

Medcura, Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, announces that the U.S. Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel™ Absorbable Surgical Hemostat. LifeGel™ is the first and only hemostatic agent to receive Breakthrough Device Designation seeking a new and highly…

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ABM Respiratory Care Announces the FDA Clearance of the Biwaze Clear System

ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the BiWaze® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung…

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Endoluxe Announces First ENT Procedures Using Endoluxe Vision System

Endoluxe congratulates Keith Matheny, MD, FARS, of Collin County Ear Nose & Throat in Frisco, TX, for being the first ear, nose and throat (ENT) surgeon in the U.S. to use the Endoluxe Vision System for endoscopic sinus surgery. Dr. Matheny is a nationally-known innovator in the field of Otolaryngology and has developed or been…

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Sonorous NV Uses New Device to Treat Patients with Symptomatic Cerebral Venous Diseases

Sonorous NV, Inc. Chairman, Dave Ferrera, announced treatment of the first patients in North America with the BossStent® device designed to treat patients with symptomatic cerebral venous diseases. The single-use, implantable device acts as an endoluminal prothesis that is placed into a cerebral venous sinus stenosis to normalize blood flow and pressure gradients causing pulsatile tinnitus and/or IIH (idiopathic intracranial hypertension),…

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Lazurite is Recognized in the 2022 Medical Device Network Excellence Awards & Rankings for its ArthroFree™ System

Medical device and technology company Lazurite has received recognition from Medical Device Network Excellence Awards & Rankings, one of the largest, most prestigious, and widely recognized programs in the industry. Lazurite ranked as Commended for the Innovation, Product Launches and Research and Development categories. All Commended companies will be entered into the Medical Device Network…

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Activ Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light

Activ Surgical, a digital surgery pioneer, announced that it is has received CE Mark approval for its ActivSight™ Intelligent Light (“ActivSight”). The CE Mark validates that ActivSight meets the requirements of the European Medical Devices Regulation, allowing Activ Surgical to commercialize the enhanced imaging system across the European Union and other CE Mark required regions.…

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New View Surgical, Inc. Closes $12.1M Series B-1 Financing, Readies Limited Market Release of its VisionPort™ System For Minimally Invasive Surgery

New View Surgical, Inc., an emerging medical device company developing proprietary imaging and access technologies for minimally invasive surgery (MIS), announced the closure of a $12.1M Series B-1 equity financing round to fund the commercialization of its VisionPort™ System. The company expects to launch the VisionPort System in the US before the end of 2022.…

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