• Filter By:
• Specialty
• Source
• Condition
• Cancer
• Infectious Disease
• Drug
• Training
• Management
• Procedure
• Therapy
• Vaccine
• Nutrition
• Country

Nico touts studies using BrainPath to treat hemorrhagic stroke
Nico Corp today released data from 2 recently published studies which utilized its BrainPath Approach to treat hemorrhagic stroke, touting a 95% clot reduction and no mortalities associated with the device. The BrainPath system uses a shunt and specially designed instrumentation to give surgeons access to the subcortical section of the brain. The device won 510(k) clearance from the FDA last June for treating primary and secondary brain tumors, vascular abnormalities, intraventricular tumors or cysts. Data from the studies was published in the journals Neurosurgery and Operative Neurosurgery, the Indianapolis-based c...
Source: Mass Device - June 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Neurological Surgical Nico Corp. Source Type: news

4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression. Previously, Shook was Co-founder, Director, President, an...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Source Type: news

Samsung ’ s NeuroLogica, MaxQ AI ink collab distro deal
Samsung Electronics (LON:BC94) subsidiary NeuroLogica said today that it inked a distribution deal with MaxQ AI to integrate its artificial intelligence software with NeuroLogica’s medical imaging tech in the U.S. and EU’s acute care marketplace. Through the deal, NeuroLogica said that it will offer MaxQ’s Accipio IX, part of the AI-company’s FDA-cleared and CE Mark approved Accipio Insight intracranial hemorrhage platform intended to support acute care physicians by identifying patients with suspected intracranial hemorrhage using non-contrast head computed tomography imaging. “We are honore...
Source: Mass Device - November 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Imaging Neurological Software / IT maxqai NeuroLogica Corp. samsung Source Type: news

Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news