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Imaging Visualization & Navigation

FDA Clears Two Siemens Healthineers CT Systems Dedicated for Radiation Therapy Planning 

The U.S. Food and Drug Administration (FDA) has cleared the SOMATOM go.Sim and SOMATOM go.Open Pro – two computed tomography (CT) systems from Siemens Healthineers that are dedicated for radiation therapy (RT) planning. The 64-slice SOMATOM go.Sim and 128-slice SOMATOM...

December 17, 2019

Imaging Visualization & Navigation

FDA Approves Diffusion-Weighted Images for Elekta Unity, Expanding Options for Assessment During Therapy

Elekta today announced that it has received 510(k) premarket notification from the U.S. Food and Drug Administration for the use of diffusion-weighted MR images (DWI) obtained with Elekta Unity to be interpreted by a trained physician. This expands the clinical...

December 16, 2019

Cardiovascular / Cardiology

First Patient Enrolls in New Trial for Abiomed’s Impella Looks for Heart Failure Reduction

Abiomed (NASDAQ: ABMD) announces initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will reduce infarct...

December 16, 2019

Surgery and Surgical Robotics

Aptar’s Nasal Unidose Device Approved by U.S. FDA for First Nasal Rescue Treatment for Frequent Seizure Activity 

AptarGroup, Inc., a global leader in drug delivery, consumer product dispensing and active packaging solutions, today announced that its patented Unidose Liquid System is the device delivering the first and only nasal rescue treatment approved by the U.S. FDA, which...

December 12, 2019

Diagnostics & Healthcare News

ImpediMed Receives FDA 510(k) Clearance of SOZO for Expanded Indication

ImpediMed Limited (ASX.IPD), a medical software technology company that non-invasively measures, monitors and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS), recently announced the issuance of a further 510(k) clearance for SOZO® by the U.S. Food and Drug...

December 12, 2019

Diagnostics & Healthcare News

Beta Bionics Receives FDA Breakthrough Device Designation for the iLet Bionic Pancreas System

Beta Bionics, Inc. — a medical technology company developing and aiming to commercialize the world’s first fully automated bionic pancreas — today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its investigational...

December 11, 2019

Surgery and Surgical Robotics

MolecuLight Receives FDA 510(k) Clearance for its i:X Handheld Fluorescence Imaging Device for Wound Management 

MolecuLight Inc., the world’s leader in handheld fluorescence imaging for real-time visualization of fluorescence in wounds, has received FDA 510(k) clearance for its i:X® handheld fluorescence imaging device for use in the detection of wounds containing bacteria. This FDA 510(k) clearance is...

December 10, 2019

Diagnostics & Healthcare News

Nihon Kohden Launches Life Scope SVM-7200 Series Vital Sign Monitor, a Portable, Easy-to-Use Monitor with Customizable Early Warning Scoring 

Nihon Kohden, a U.S. market leader in precision medical products and services, today announced the launch of its Life Scope® SVM-7200 Series vital signs monitor, a monitor designed for outpatient facilities and beds that traditionally are not continuously monitored. The...

December 10, 2019

Diagnostics & Healthcare News

IRRAflow Wins CONNECT’s “2019 Most Innovative New Product” Award

Breakthrough medical device that transforms treatment of intracranial bleeding recognized as most innovative new medical device from southern California. IRRAS AB, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that IRRAflow has been...

December 9, 2019