medical device guru

Cardiovascular / Cardiology

BioVentrix® Closes $48.5 Million Series A Financing

BioVentrix, Inc., a privately held medical device company developing minimally invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process in patients with congestive heart failure, today announced the completion of $48.5 million Series A round...

April 13, 2023

Orthopedics and Spine

Abyrx Receives Additional FDA Clearances for MONTAGE® Settable, Resorbable Bone Putty as Bone Void Filler and Cranial Bone Cement

Abyrx, Inc. (http://abyrx.com), a leading biomaterial sciences company with a focus on therapeutic technologies for use during surgical procedures, today announced its receipt of additional United States Food and Drug Administration (FDA) clearances for the company’s MONTAGE® Settable, Resorbable Bone...

April 12, 2023

Orthopedics and Spine

FDA Authorizes Marketing of MISHA™ Knee System for People Suffering from Knee Osteoarthritis

Moximed, a medical device company on a mission to improve the standard of care for people with knee osteoarthritis (OA), today announced that the U.S. Food and Drug Administration (FDA) granted marketing authorization of the MISHA™ Knee System, an implantable...

April 11, 2023

Orthopedics and Spine

restor3d Receives FDA Clearance of Patient Specific Resection Guides for use with the Kinos Axiom Total Ankle System

restor3d, a research-driven medical device company, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR (patient-specific resection) System...

April 7, 2023

Cardiovascular / Cardiology

Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT®

Icentia Inc., announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. “This approval marks a key milestone for our company. The FDA clearance opens the door...

April 6, 2023

Cardiovascular / Cardiology

Synapse Biomedical Wins New Approval for Diaphragm Pacing System to Free Patients from Ventilators

Synapse Biomedical, Inc. announced today that the FDA has granted premarket approval (PMA) of the NeuRx® Diaphragm Pacing System (NeuRx DPS®) for use in patients with spinal cord injuries who rely on mechanical ventilation. PMA is the most stringent type of...

April 5, 2023

Biologics, Wound Care, Infection Prevention

ExtriCARE USA Introduces the extriCARE 3000 Pump to NPWT Market

ExtriCARE USA, is pleased to announce that its innovative extriCARE 3000 pump has received FDA approval for use in the United States. The extriCARE 3000 pump is a state-of-the-art medical device designed to provide versatile and effective wound care treatment...

April 3, 2023

Cardiovascular / Cardiology

Positive Results From PROMISE II Pivotal Trial Showing that LimFlow System Saves Most Patients with End-stage Peripheral Artery Disease From Major Amputation

LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that results from the PROMISE II U.S. pivotal trial were published in...

March 30, 2023

Diagnostics & Healthcare News

Ad Astra Diagnostics Files 510(k) for QScout™ Hematology Analyzer

Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its QScout RLD rapid-result hematology system intended to report white blood cell count, neutrophil-to-lymphocyte ratio, and...

March 30, 2023