Posts by rw-admin
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 device marketing application required by FDA. More hospitals are expected to begin implementing the NeuRx…
Read MoreExtriCARE 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 for patients. The extriCARE 3000 pump is a breakthrough in negative pressure wound therapy (NPWT)…
Read MorePositive 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 today’s issue of the New England Journal of Medicine (NEJM). The results demonstrated that the…
Read MoreAd 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 counts of six white blood cell types in fingerstick or venous blood. QScout is the…
Read MoreHow 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? We’re guessing the second option. So why are we letting our workplace communication get so…
Read MoreAdvamedica 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 surgical bleeding. Ax-Surgi is based on novel biopolymer platform and controls bleeding through its bioadhesive…
Read MoreFemDx 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 is the first totally disposable 1.2mm diameter falloposcope incorporating a CMOS chip endoscope to evaluate…
Read MoreAncora 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 heart. The 12-month data were presented as part of a late-breaking clinical science session at…
Read MoreFDA 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 liver outcomes and connecting them with preventative care and treatment options. The new clearance removes…
Read MoreLumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal
Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT™ Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). LUMISIGHT is intended for use with the Lumicell™ Direct Visualization System (DVS), an investigational system designed…
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