medical device guru

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
Imaging Visualization & Navigation
MIT Researchers Produce First Laser Ultrasound Images of Humans 
For most people, getting an ultrasound is a relatively easy procedure: As a technician gently presses a probe against a patient’s skin, sound waves generated by the probe travel through the skin, bouncing off muscle, fat, and other soft tissues...
December 31, 2019
Cardiovascular / Cardiology
Masimo Announces FDA Clearance for Neonatal RD SET Pulse Oximetry Sensors with Improved Accuracy Specifications 
Masimo announced today that RD SET® sensors with Masimo Measure-through Motion and Low Perfusion™ SET® pulse oximetry have received FDA clearance for improved oxygen saturation (SpO2) accuracy specifications for neonatal patients (< 3 kg). The updated RD SET® sensors’ SpO2 accuracy specifications have improved significantly,...
December 30, 2019
Surgery and Surgical Robotics
Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision, the First Augmented Reality Guidance System for Surgery
Augmedics, a pioneer in augmented reality surgical image guidance, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its groundbreaking xvision Spine system (XVS), the first AR guidance system to be used in surgery....
December 26, 2019
Orthopedics and Spine
Life Spine Announces FDA 510(k) Clearance of the Titanium Stand-Alone ALIF Spacer System 
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the Titanium Stand-Alone...
December 23, 2019
Diagnostics & Healthcare News
Opsens Inc. Announces 510(k) Clearance from the FDA to Market its Diastolic Pressure Algorithm
Opsens Inc. announces 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its diastolic pressure algorithm (“dPR”). Coronary physiology has been in constant evolution with the expanded use of Fractional Flow Reserve (“FFR”) and the support of strong...
December 23, 2019
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