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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

Surgery and Surgical Robotics

IRRAS Receives Renewed CE Mark for the IRRAflow Catheter

IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it received CE Mark approval for its IRRAflow®catheter. This CE Mark complements the two CE Marks previously obtained for the IRRAflow system’s tube set with digital...

December 19, 2019

Diagnostics & Healthcare News

Baebies Announces CE Mark for FINDER, an Innovative Near-Patient Testing Platform for Glucose-6-Phosphate Dehydrogenase 

Baebies is pleased to announce that FINDERTM, a near-patient testing platform, now has CE Mark as an In Vitro Diagnostic device (IVD) and is commercially available in Europe and other countries that recognize CE Mark. The CE-Marked platform includes an instrument and...

December 19, 2019

Surgery and Surgical Robotics

Medtronic Expands Surgical Synergy(SM) with FDA Clearance of the Stealth Autoguide System for Cranial Procedures 

Medtronic plc announced that the U.S. Food and Drug Administration (FDA) recently cleared the Stealth Autoguide™ system, the first cranial robotic platform that integrates with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution. The Stealth Autoguide Platform is...

December 19, 2019

Cardiovascular / Cardiology

Clinical Study Utilizes the myTAIHEART Test to Monitor Cell-Free DNA Levels, 2-10 Days Post-Transplantation, in Pediatric Heart Transplant Recipients 

TAI Diagnostics, Inc., focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, today announced the publication of “Early Changes in Cell-Free DNA Levels in Newly Transplanted Heart Transplant Patients” in the December 11th open access version of Pediatric Transplantation, the...

December 18, 2019