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Orthopedics and Spine
Catalyst OrthoScience Receives FDA 510(k) Clearance of Its Reverse Shoulder System
Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, has received clearance from the U.S. Food & Drug Administration (FDA) to market its reverse shoulder system. Catalyst expects to begin a limited user release in...
March 21, 2021
Cardiovascular / Cardiology
Qardio Lands 510(k) for Ambulatory ECG Device
Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device.  QardioCore will initially be marketed for holter monitoring applications, for use with QardioMD, Qardio’s cloud-based remote patient monitoring solution....
March 21, 2021
Cardiovascular / Cardiology
Imbio Receives FDA 510(k) Clearance for New Cardiothoracic Imaging Algorithm
Imbio, a leading provider of artificial intelligence (AI) solutions for medical imaging analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RV/LV Analysis™ algorithm. The RV/LV Analysis algorithm is a rapid, automated assessment of potential right ventricular dilation. The...
March 21, 2021
Imaging Visualization & Navigation
Quibim Receives FDA 510(k) Clearance for qp-Prostate AI Solution for Prostate MRI Analysis
Quibim, a global leader in whole-body medical imaging analysis, announced today the launch of qp-Prostate, its latest and most advanced prostate AI based Magnetic Resonance (MR) solution, after receiving 510(k) clearance by the US Food and Drug Administration. The solution aids...
March 14, 2021
Surgery and Surgical Robotics
Preceptis Medical Announces Publication of Positive Results from Pediatric In-Office Study of the Hummingbird Tympanostomy Tube System (TTS)
Preceptis Medical, Inc., a company dedicated to helping ENT surgeons improve how they care for children, today announced positive results from a prospective, multicenter study designed to assess in-office pediatric ear tube placement with the FDA-cleared Hummingbird Tympanostomy Tube System...
March 14, 2021
Cardiovascular / Cardiology
Access Vascular Inc. Secures $20 Million in Series B Financing
Access Vascular, Inc., a company addressing the most common and costly venous access complications, today announced it has closed on a Series B round of financing. TVM Capital Life Science led the round with a $15 million commitment, with existing...
March 14, 2021
Cardiovascular / Cardiology
Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease
Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced last month that the company’s sonic pressure wave therapy received Pre-Market Approval for severely calcified coronary artery disease from the U.S....
March 7, 2021
Surgery and Surgical Robotics
FDA Grants Breakthrough Device Designation for Anuncia’s Cerebral Spinal Fluid Treatment
Anuncia Inc., an emerging leader in Cerebral Spinal Fluid (CSF) management, received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its ReFlow™ System Mini intended for the treatment of CSF disorders requiring shunting such as hydrocephalus, a debilitating and...
March 7, 2021
Orthopedics and Spine
NuVasive Acquires Simplify Medical
NuVasive, Inc., the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it has acquired Simplify Medical, a privately held company and developer of the Simplify® Cervical Artificial Disc (Simplify Disc)...
February 28, 2021
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