Posts by cstephenson@legacymedsearch.com
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, or cardiac magnetic resonance (CMR), its use has been largely limited due to a lack…
Read MoreSiemens 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 stockholders approved the acquisition. The relevant governmental authorities previously granted the approvals required to complete…
Read MoreNeuronetics® 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 transcranial magnetic stimulation (TMS), a non-drug, non-invasive treatment for adult patients with Major Depressive Disorder…
Read More3D 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 vessel with a dual-layer architecture that outperforms existing engineered tissue and brings 3D-printed blood vessels…
Read MoreU.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 ERCP procedures. ScopeSeal® is a single-use disposable infection control device that preserves duodenoscope optics and other…
Read MoreB9 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 B9 Core Med 500 and the first two of its suite of biocompatible materials. With…
Read MoreCorFlow 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 platform for controlled infusion of therapeutic agents into the microcirculation with or without vessel occlusion.”…
Read MoreAuris 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 BENEFIT study was presented in a late-breaking session at the CHEST 2019 Conference in New Orleans by Alexander…
Read MoreLess 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 and Aquilion ONE / GENESIS EditionTM premium CT systems, uses a deep learning algorithm to differentiate…
Read MoreA Better Night’s Sleep – ResMed Introduces AirFit N30, World’s First Tube-Down Nasal Cradle CPAP Mask
ResMed introduced AirFit N30, the world’s first tube-down nasal cradle CPAP mask with a front-facing tube – a brand-new option for sleep apnea treatment. ResMed’s lightest mask yet, AirFit N30 features an adjustable elastic headgear, plus a nasal cradle cushion that sits under the nasal bridge, eliminating soreness in that area. The mask’s curved cushion…
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