medical device guru

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

Resource Library

How Office Buzzwords are Hurting Your Communication, and How to Fix it

Let’s do a deep dive on best practices to maximize our synergy to move the needle on low-hanging fruit. Or, let’s collaborate on some processes to get started on our most attainable objectives.   So, which one sounds better?  ...

March 29, 2023

Surgery and Surgical Robotics

Advamedica Inc announces FDA clearance for Ax-Surgi Surgical Hemostat

Advamedica Inc., a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. With this, Ax-Surgi has become first and only chitosan based hemostat cleared for controlling severe...

March 29, 2023

Imaging Visualization & Navigation

FemDx Medsystems, Inc. Receives FDA Clearance For Its FalloView™ Falloposcope

FemDx Medsystems, Inc., a women’s health startup based in Santa Clara, CA announces the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its FalloView™ device. According to Ashlee Francis, CEO of FemDx Medsystems, Inc., the device...

March 27, 2023

Cardiovascular / Cardiology

Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients

Ancora Heart, Inc., a company developing a completely transcatheter device-based therapy to address heart failure (HF), announced that patients treated with the investigational AccuCinch® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the...

March 24, 2023

Imaging Visualization & Navigation

FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management

The U.S. Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan®, the non-invasive liver management technology by Echosens. The update furthers FibroScan® accessibility to more people, enabling physicians to identify those at risk of suffering adverse...

March 22, 2023