medical device guru

Cardiovascular / Cardiology

BioCardia Announces FDA Clearance for Morph DNA Catheter to Guide Cell Delivery into Heart Tissue

BioCardia (BCDA)®, Inc. , a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable guide catheter used to guide the Helix™...

January 20, 2020

Surgery and Surgical Robotics

TransEnterix Announces Submission of 510(k) to FDA for First Machine Vision System in Robotic Surgery 

TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced the Company filed a 510(k) submission with an Intelligent Surgical Unit (ISUTM)1 that is designed...

January 16, 2020

Orthopedics and Spine

CoreLink Surpasses 5,000 Implants With Proprietary 3D Printed Technology 

CoreLink, LLC, a leading designer and manufacturer of spinal implant systems, today announced the implantation of over 5,000 3D printed devices using their proprietary Mimetic Metal® technology. Mimetic Metal is an additively manufactured technology that combines a lattice framework and inner trabecular...

January 16, 2020

Surgery and Surgical Robotics

Machine Keeps Livers Alive for a Week, Revives Injured Ones

Researchers from the UniversityHospital Zurich, ETH Zurich, Wyss Zurich and the University of Zurich have developed a machine that repairs injured human livers and keeps them alive outside the body for one week. This breakthrough may increase the number of...

January 15, 2020

Diagnostics & Healthcare News

Phagenesis Wins FDA Breakthrough Nod for Phagenyx System for Restoring Swallowing

Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Phagenyx System. The Phagenyx System is a...

January 14, 2020

Diagnostics & Healthcare News

AI Saving Brain: FDA Clears Aidoc’s Complete AI Stroke Package

Aidoc, the leading provider of AI solutions for radiologists, today announced that the US Food and Drug Administration (FDA) has cleared its AI solution for flagging Large-Vessel Occlusion (LVO) in head CTA scans, marking Aidoc’s fourth FDA-cleared AI package. Combined with Aidoc’s...

January 13, 2020

Cardiovascular / Cardiology

Colospan Wins IDE FDA Approval for Intraluminal Bypass Device

Colospan which develops novel solutions for colorectal surgery, announced today that the United States Food and Drug Administration (FDA) has approved the company’s investigational device exemption (IDE) application. With this IDE approval in hand, the company will launch its pivotal study...

January 9, 2020

Cardiovascular / Cardiology

FDA Grants Breakthrough Device Designation to Reflow Medical’s Temporary Spur Stent System 

Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA)....

January 9, 2020

Surgery and Surgical Robotics

Virtual Incision Announces $20 Million Financing to Advance First-of-its-Kind Surgical Mini-Robot 

Virtual Incision Corporation, a medical device company pioneering a first-of-its-kind miniaturized surgical robot, announced it has raised $20 million in a Series B+ financing led by returning investor Bluestem Capital, with participation from returning investor PrairieGold Venture Partners, as well...

January 8, 2020