medical device guru

Cardiovascular / Cardiology

Imricor’s MRI-Compatible Ablation Catheters Cleared in Europe for Cardiac Arrhythmia Treatment

Imricor Medical Systems, Inc. (ASX:IMR) today announces that it has received CE mark approval for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode. This follows earlier CE mark approval for Imricor to place its Advantage-MR EP Recorder/Stimulator System on the market...

January 30, 2020

Cardiovascular / Cardiology

FDA Clears Eko’s AFib and Heart Murmur Detection Algorithms, Making It the First AI-Powered Stethoscope to Screen for Serious Heart Conditions

Eko, a digital health company applying artificial intelligence (AI) in the fight against heart disease, announced today that the U.S. Food and Drug Administration has cleared a suite of algorithms that, when combined with Eko’s digital stethoscopes, will enable healthcare...

January 29, 2020

Diagnostics & Healthcare News

BioIntelliSense Announces FDA Clearance of the BioSticker, a Single-Use Medical Device Enabling 30 Days of Continuous Vital Signs Monitoring

BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, today announces the U.S. commercial launch of its medical grade Data-as-a-Service (DaaS) platform and FDA 510(k) clearance of the BioSticker™ on-body sensor for scalable remote care. BioIntelliSense offers a new...

January 28, 2020

Biologics, Wound Care, Infection Prevention

Advanced Sterilization Products Unveils the Fastest Biological Indicator for Hydrogen Peroxide Sterilization

Advanced Sterilization Products (ASP) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a 15-minute time to result on the STERRAD VELOCITY® Biological Indicator (BI)/Process Challenge Device (PCD) for use in STERRAD® Systems.* The 15-minute time...

January 28, 2020

Surgery and Surgical Robotics

GT Medical Technologies Announces FDA Clearance of Expanded Indication for GammaTile Therapy 

GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for GammaTile® Therapy. Patients with newly diagnosed malignant brain tumors...

January 27, 2020

Surgery and Surgical Robotics

Cardinal Begins Recall of 9.1M Surgical Gowns Amid Sterility Concerns 

Details of the quality problems and Cardinal’s response to them have trickled out in January. Cardinal told customers it learned of problems with environmental conditions at a site that makes gowns last week, leading to a voluntary product hold. At...

January 23, 2020

Diagnostics & Healthcare News

Dimer Offers New Germ-Killing Robot to Disinfect Airplanes at Key US Airports to Protect Passengers from Coronavirus Outbreak

Dimer UVC Innovations is offering its GermFalcon®, a germ-killing robot that sanitizes airplanes, to assist airlines and federal agencies disrupt the spread of a new pneumonia-like illness originating in the Wuhan region of China. The service is being offered at no...

January 23, 2020

Cardiovascular / Cardiology

VivaLNK Announces World’s First FDA Cleared Wearable ECG Sensor Platform

VivaLNK, a leading provider of connected healthcare solutions, today announces it received FDA clearance for its Continuous ECG Platform. Consisting of reusable wearable ECG sensors and associated software development kit (SDK), the sensor platform gives developers and providers direct control...

January 23, 2020

Surgery and Surgical Robotics

Phoenix Children’s Is the First-Ever Health System in the U.S to Use Medtronic Stealth Autoguide Cranial Robotic Guidance Platform for Neurosurgery

Nationally ranked pediatric leader, Phoenix Children’s Hospital, is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide™ platform. Medtronic, a global leader in medical technology, chose Barrow Neurological Institute (BNI) at Phoenix...

January 22, 2020