medical device guru

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
Imaging Visualization & Navigation
Lumicell 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...
March 21, 2023
Surgery and Surgical Robotics
Asensus Surgical Receives FDA 510(k) Clearance For Pediatric Indication for Senhance Surgical System
Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™ (PGS), announced that it has received 510(k) clearance from the FDA...
March 20, 2023
DermaSensor Unveils Study Results Demonstrating Ability to Detect Skin Cancer With Device Granted FDA Breakthrough Designation
DermaSensor Inc., a health technology company equipping primary care physicians (PCPs) with a non-invasive device for use in evaluation of suspicious skin lesions, presented a pooled analysis today from two clinical studies evaluating the performance of the company’s device in...
March 17, 2023
Prolira Announces FDA Clearance of the DeltaScan® Brain State Monitor for Detecting Acute Encephalopathy (Acute Brain Failure), a Condition Affecting Millions of Hospitalized Patients 60 and Older
Prolira BV, a high-tech company committed to enabling early and effective treatment of patients at risk of developing acute brain failure, announced it has received 510(k) clearance from the Food and Drug Administration (FDA) for the DeltaScan® Brain State Monitor...
March 16, 2023
1 3 4 5 6 7 161