medical device guru

Cardiovascular / Cardiology

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...

September 13, 2022

Surgery and Surgical Robotics

Aerin 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...

September 12, 2022

Surgery and Surgical Robotics

Serpex 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...

September 8, 2022

Surgery and Surgical Robotics

Magnus 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...

September 6, 2022

Surgery and Surgical Robotics

eCential 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...

September 1, 2022

Surgery and Surgical Robotics

CereVasc 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...

August 29, 2022

Cardiovascular / Cardiology

Miracor 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...

August 25, 2022

Diagnostics & Healthcare News

MedWand 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...

August 22, 2022

Resource Library

It’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...

August 19, 2022