medical device guru

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

Imaging Visualization & Navigation

Google AI Tool Bests Clinicians in Breast Cancer Detection Study 

A Google artificial intelligence tool may predict breast cancer better than doctors, according to a study published Wednesday in the journal Nature. The algorithm, which was trained on almost 91,000 mammogram scans from women in the U.S. and U.K., resulted in almost...

January 3, 2020

Diagnostics & Healthcare News

TAP At-Home Blood Collection System Now FDA Cleared

Seventh Sense Biosystems, Inc. (7SBio) announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) authorization to extend its existing clearance to include blood collection by laypersons. Regulators are also allowing the device to be used...

January 3, 2020

Surgery and Surgical Robotics

Interscope Announces New FDA Clearance of the EndoRotor, for Use in Airway Procedures Including in Interventional Pulmonology

Interscope, Inc. announced today the receipt of marketing clearance from the FDA for the EndoRotor® System to commercialize Pulmonary indications.  Interscope innovated the first flexible microdebrider for use by medical specialists in the digestive tract with reported results reducing the need...

January 2, 2020

Surgery and Surgical Robotics

Foresee-X Augment Reality Solution from SURGLASSES Is Registered with the FDA and Ready for Trauma Treatment

Foresee-X is a set of smart surgical glasses with functionality based on augmented and mixed reality technologies. This device was developed by SURGLASSES, also known as Taiwan Main Orthopaedic Biotechnology Co. Ltd., and has received IEC60601-1-2 and ISO 13485 certifications. It...

January 2, 2020