medical device guru

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
Biologics, Wound Care, Infection Prevention
REVIAN Inc. Announces Issuance of Landmark Patent Covering the Use of Light to Stimulate the Body to Heal Itself 
REVIAN Inc. (formerly PhotonMD Inc.), a medical technology company dedicated to stimulating the body’s natural processes to rejuvenate hair and skin with light, is pleased to announce that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No....
January 8, 2020
Surgery and Surgical Robotics
Medtronic Warns of Mazor X Detachment Issue in Robotic Surgery
Users of Medtronic’s Mazor X Surgical System may experience a hardware detachment problem in which a system piece unexpectedly releases from the OR table, according to an urgent field safety notice issued by the company in December. Medtronic said it had received...
January 7, 2020
Orthopedics and Spine
Intralink-Spine, Inc: Announces Continuation of CLBP Clinical Study 
Intralink-Spine, Inc. (ILS) announces that it has received unanimous approval from the Data Safety Monitoring Board (DSMB) to proceed with the Réjuve® clinical safety study (GEM-SE) for chronic low back pain (CLBP). As a result, ILS will be adding new...
January 7, 2020
Cardiovascular / Cardiology
ZipThaw, the World’s First Portable, Precise Plasma Thawing Medical Device, Receives FDA Clearance for Clinical Use
FreMon Scientific is pleased to announce the FDA has now cleared ZipThaw™ for frozen plasma thawing as a Class II medical device. ZipThaw, used with the ZipSleeve™ anti-contaminant disposable barrier, is the world’s first dry and portable precision plasma thawing...
January 6, 2020
Imaging Visualization & Navigation
PhotoniCare Announces FDA Clearance for First-In-Class Technology for Imaging the Ear 
PhotoniCare, Inc., a company dedicated to revolutionizing healthcare by providing physicians with better diagnostic tools, today announced that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for its TOMi™ Scope for non-invasive imaging of the middle ear. Using...
January 6, 2020
1 2 3 4 111