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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