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Imaging Visualization & Navigation

HeartVista Receives FDA 510(k) Clearance for One Click™ Cardiac MRI Package, the First AI-assisted Cardiac MRI Scan Solution

HeartVista, a pioneer in AI-assisted MRI solutions, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration to deliver its AI-assisted One Click™ MRI acquisition software for cardiac exams. Despite the many advantages of cardiac MRI,...

October 29, 2019

Cardiovascular / Cardiology

Siemens Healthineers Completes  Corindus Vascular Robotics Acquisition for $1.1B

Siemens Healthineers AG completed the acquisition of 100 percent of Corindus Vascular Robotics, Inc. effective October 29, 2019. Prior to the closing of the acquisition, Corindus held a shareholders’ meeting on October 25, 2019, at which 87.5 percent of their...

October 29, 2019

Surgery and Surgical Robotics

Neuronetics® and Success TMS Partner to Increase Patient Access to Leading Depression Treatment, NeuroStar® Advanced Therapy

Neuronetics, Inc., a commercial stage medical technology company focused on designing, developing and marketing products that improve the quality of life for patients who suffer from psychiatric disorders, today announced a partnership with Success TMS, a healthcare provider specializing in...

October 28, 2019

Cardiovascular / Cardiology

3D Printed Cells and Bioinks for Making Implantable Blood Vessels

A biomimetic blood vessel was fabricated using a modified 3D cell printing technique and bioinks, which were formulated from smooth muscle cells from a human aorta and endothelial cells from an umbilical vein. The result is a fully functional blood...

October 28, 2019

Surgery and Surgical Robotics

U.S. FDA Clears GI Scientific’s ScopeSeal®, the Only Single-Use Disposable Device Indicated to Significantly Reduce Duodenoscope Contamination

GI Scientific, LLC, a developer of transformative innovations for gastrointestinal disease, announced that the U.S. Food and Drug Administration (FDA) cleared its ScopeSeal® Duodenoscope Protective Device, the first Endoscopic Shield® for protecting the distal end of a duodenoscope from contamination during...

October 24, 2019

Diagnostics & Healthcare News

B9 Creations Unveils Their New, Cutting-Edge 3D Printer

B9Creations, a global provider of 3D printing solutions, announced today the launch of its new additive manufacturing Healthcare Division & Service Bureau and new medical upgrade to its award-winning B9 Core Series 3D printer line with the launch of the...

October 23, 2019

Cardiovascular / Cardiology

CorFlow Therapeutics Gains “Breakthrough Device Designation” for CoFI™ (COF-fee) System

CorFlow Therapeutics AG announced that the FDA has designated the company’s CoFI (CorFlow Controlled Flow Infusion) System as a “Breakthrough Device” with a broad indication-for-use statement: “The CoFI™System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), and to be a...

October 23, 2019

Surgery and Surgical Robotics

Auris Health’s Lung Cancer Detecting Robot has Late-Breaking Results from its First-in-Human Study

Auris Health, Inc., part of Johnson & Johnson Medical Devices Companies,* announced results from a study demonstrating the safety and feasibility of the Monarch Platform, a first-of-its-kind robotic technology indicated for use in diagnostic and therapeutic bronchoscopic procedures. Data from the...

October 23, 2019

Imaging Visualization & Navigation

Less Radiation and High Resolution – Canon Medical gains FDA Clearance for AI Image Reconstruction Technology

 Canon Medical Systems USA, Inc. has received 510(k) clearance on its Advanced Intelligent Clear-IQ Engine (AiCE) for the Aquilion PrecisionTM further expanding access to its new deep convolutional neural network (DCNN) image reconstruction technology. This technology, now available on both the Aquilion Precision...

October 22, 2019