Posts by rw-admin
Potrero Medical Receives FDA Breakthrough Device Designation for Accuryn AKI Predict Algorithm
Potrero Medical announced that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients. Joe Urban, Potrero CEO stated “We celebrate the breakthrough designation, and we are excited about what this will…
Read MoreAerin Medical Receives FDA Clearance of Next-Generation RhinAer® Stylus for Treatment of Patients with Chronic Rhinitis
Aerin Medical Inc., a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. RhinAer is a non-invasive, temperature-controlled radiofrequency technology that durably treats the causes of rhinorrhea (runny nose), post-nasal drip…
Read MoreSerpex Medical Announces Second FDA 510(k) Clearance of Its Steerable Endobronchial Instrument Platform – The Compass Steerable Needle
Serpex Medical announced U.S. FDA 510(k) clearance of its Compass Steerable Needles – steerable biopsy needles that enable precise access to lung nodules in the intrapulmonary region. Serpex Medical seeks to leverage the power of steerable instruments to enable greater precision and access to improve the diagnosis and treatment of lung cancer. The clearance of…
Read MoreMagnus Medical Receives FDA Clearance for the SAINT Neuromodulation System
Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for treatment of neuropsychiatric disorders, announced it received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the SAINTTM Neuromodulation System for the treatment of major depressive disorder (MDD) in adults who have failed to achieve satisfactory improvement from prior antidepressant…
Read MoreeCential Robotics Receives FDA Clearance for its Surgical Robotic Platform for Spine Surgery
eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform in the United States. After having recently concluded partnership with US implant companies, eCential Robotics…
Read MoreCereVasc Announces FDA Approval of Second IDE Study of the eShunt® System
CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). “We are…
Read MoreMiracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study
Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. The PiCSO-AMI-II multicenter, randomized trial will enroll 300 patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) presenting with TIMI flow…
Read MoreMedWand Solutions Receives FDA 510k Clearance
MedWand Solutions, Inc. is pleased to announce that the company’s groundbreaking MedWand device and VirtualCare ecosystem is commercially available to enable clinical exams with its comprehensive care solutions. Poised to transform the current capabilities of telemedicine, MedWand is offering various kits including: the MedWand Evaluation Kit, the MedWand Mobile Clinic, and the MedWand Remote Clinic. By facilitating a more…
Read MoreIt’s What’s in the Middle That Counts: How to format your name on a Resume
Why you should include your Middle Initial or Name in your Resume The best-selling cookie in the world is the Oreo. In fact, if all the Oreo’s ever made were stacked, they could reach the moon and back five times and more than 450,000,000,000 have been sold since their debut in 1912. I’m one of…
Read MorePreceptis Medical Receives FDA Clearance for Expanded Labeling for Hummingbird System
Preceptis Medical, Inc., an innovative surgical technology company dedicated to providing less invasive options for pediatric patients, announced U.S. FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously cleared in children 6-24 months, this new labeling allows in-office procedures in all children six…
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