medical device guru

Surgery and Surgical Robotics

Asensus Surgical Receives FDA 510(k) Clearance For Pediatric Indication for Senhance Surgical System

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™ (PGS), announced that it has received 510(k) clearance from the FDA...

March 20, 2023

Surgery and Surgical Robotics

Prolira Announces FDA Clearance of the DeltaScan® Brain State Monitor for Detecting Acute Encephalopathy (Acute Brain Failure), a Condition Affecting Millions of Hospitalized Patients 60 and Older

Prolira BV, a high-tech company committed to enabling early and effective treatment of patients at risk of developing acute brain failure, announced it has received 510(k) clearance from the Food and Drug Administration (FDA) for the DeltaScan® Brain State Monitor...

March 16, 2023

Surgery and Surgical Robotics

Aquablation Therapy is the first surgical robotics system to receive a MedTech Innovation Briefing (MIB) from the National Institute for Health Care Excellence

PROCEPT® BioRobotics Corporation today announced Aquablation Therapy received a MedTech Innovation Briefing (MIB) from the National Institute for Health Care Excellence (NICE), for benign prostate hyperplasia (BPH) in the United Kingdom. NICE has recognized Aquablation Therapy is as effective as transurethral resection of the...

March 9, 2023

Surgery and Surgical Robotics

Lumendi Receives 510(k) Clearance for Two New Devices

Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. The new, more cost-effective design, based...

February 21, 2023

Surgery and Surgical Robotics

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...

February 3, 2023

Surgery and Surgical Robotics

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...

January 31, 2023

Surgery and Surgical Robotics

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...

January 24, 2023

Surgery and Surgical Robotics

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...

January 12, 2023

Surgery and Surgical Robotics

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...

January 4, 2023