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Sunday, May 20, 2018

In the Spotlight

Medical Device News Magazine is a digital publication that reports medical device industry news which is of interest to the practicing medical specialist, industry executive and investor. The publication is a division of PTM Healthcare Marketing, Inc.

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Karl Storz

KARL STORZ Commercial Launches of the PDD Blue Light Flexible Video Cystoscopy System

5/18/18: This announcement follows the approval of a supplemental new drug application and a Premarket Approval supplement from the U.S. Food & Drug Administration (FDA) extending the indication for Blue Light Cystoscopy with Cysview® (BLCC) to include use of the new KARL STORZ PDD Blue Light Flexible Video Cystoscope.

Brainomix

Brainomix and Olea Medical Join Forces to Revolutionize Stroke Imaging With the e-STROKE SUITE

5/17/18: Brainomix started as a spin-off from the University of Oxford in 2010 and has evolved into a world-leading, AI-based medical imaging software company dedicated to improving outcomes of patients with neurological and cerebrovascular disorders.

BREAKING NEWS

KARL STORZ Commercial Launches of the PDD Blue Light Flexible Video Cystoscopy System

Today KARL STORZ Endoscopy-America, Inc., announced the commercial launch of...

Olympus Expands Its Endoscope Reprocessing Portfolio to Include ChanlDry Drying Cabinet, Endo SafeStack Transport Cart and Visual Reprocessing Guide

5/17/18: "In an era of antibiotic-resistant bacteria, we share a responsibility with our customers to maintain the safety of endoscopes," said Kurt Heine, Group Vice President, Endoscopy Division at Olympus America Inc. "From endoscopic procedures to transport, reprocessing and storage, endoscopes are at risk of jostling-related damage or retained moisture that can invite bacteria. A strategy to provide more than disinfection but also drying and transport protection will aid in the fight against bacteria. Our video guide coupled with our new transport and storage products will help technicians fight against bacteria and protect their valuable equipment during an endoscope's complete journey throughout the day."

Brainomix and Olea Medical Join Forces to Revolutionize Stroke Imaging With the e-STROKE SUITE

5/17/18: Brainomix started as a spin-off from the University of Oxford in 2010 and has evolved into a world-leading, AI-based medical imaging software company dedicated to improving outcomes of patients with neurological and cerebrovascular disorders.

Minomic Completes Prospective Clinical Study Using MiCheck® to Assist in Diagnosis of Prostate Cancer

5/17/18: The prospective trial demonstrated that using MiCheck® could reduce the number of patients (with a clinically elevated PSA) proceeding to biopsy by up to 58%.

Surgeons Use 3D Printing for Two-Year-Old’s Life-Saving Kidney Transplant at Guy’s and St Thomas’ NHS Foundation Trust

5/17/18: This is exemplified in the case of two-year-old Dexter Clark, who recently received a larger-than-average kidney from his father, Brendan Clark. 3D printing played an important role in the operation, according to Mr. Pankaj Chandak, Transplant Registrar at Guy’s and St Thomas’ NHS Foundation Trust.

U.S. Study of Drug-Eluting Stents to Evaluate Treatment of Bifurcation Lesions in Patients with Coronary Artery Disease Commences

5/16/18: "Patients with bifurcation lesions present a unique challenge for interventional cardiologists. This study will help us evaluate these patients in a controlled setting, which will help expand our knowledge base," said Matthew J. Price, M.D., interventional cardiologist at Scripps Clinic in La Jolla, Calif., and national principal investigator of the Bifurcation Cohort of the RESOLUTE ONYX Post-Approval Study. "The unique design of Resolute Onyx DES may be well-suited to treat bifurcation lesions in a wide range of vessel sizes."

Nicklaus Children’s Hospital Becomes First Children’s Hospital to Acquire OmniTom®

5/16/18: “At Nicklaus Children’s we value the importance of investing in technology that enhances comfort and safety for our patients. The OmniTom is a step towards that continued commitment, by reducing the amount of radiation children are exposed to while enhancing safety for some of the most critical patients in our care,” said Sheryl Selinsky, Director of Radiology at Nicklaus Children’s Hospital.

NeoTract to Unveil New Clinical Data on the UroLift® System at American Urological Association 2018 Meeting

5/16/18: 1 Year Results from the study of UroLift System for the obstructive median lobe twill be presented as a late-breaking abstract.

First Patient Enrolled to the TIGER Pivotal Clinical Study

5/16/18: "We are pleased to have enrolled the first patients and to have a leadership role in the TIGER study. Stentrievers are now the gold standard for treating ischemic stroke, and TIGERTRIEVER is a new generation stentriever. Its unique design will hopefully show that it addresses the limitations of current devices and will improve patient outcomes," stated Dr. Rishi Gupta.

iSTAR Medical Reports MINIject Delivers Exceptional 6-Month Results in First-in-Human Trial

5/16/18: The results show MINIject to be safe and highly effective in achieving significant intraocular pressure (IOP) reduction in glaucoma patients.

iSchemaView Introduces RAPID™ ASPECTS

5/15/18: “In my opinion, using RAPID ASPECTS increases the likelihood of getting a reliable ASPECT score, independent of the individual skills and experience of the clinician. This tool is therefore particularly suitable for primary stroke centers with a smaller number of cases,” said Dr. Benjamin Friedrich, docent and physician in the Department of Diagnostic and Interventional Neuroradiology at the Klinikum rechts der Isar in Munich. “Early and reliable information makes it possible to quickly understand the prognosis of a patient.”

Integrated Diagnostics to Present Additional Data Analyses from PANOPTIC study at American Thoracic Society (ATS) International Conference 2018

5/15/18: Integrated classifier (Xpresys Lung 2®) provides simple and accurate method of distinguishing benign from malignant lung nodules.

Apollo Endosurgery Announces Spanish Study of ESG in NASH Patients

5/14/18: The study will involve four National Health System Hospitals, led by Professor José Luis Calleja, MD from Hospital Universitario Puerta de Hierro Majadahonda - Universidad Autónoma de Madrid, as Principal Investigator.

CurveBeam Announces FDA 510(k) Clearance for LineUP Weight Bearing Multi-Extremity CT System

5/14/18: CurveBeam President & CEO Arun Singh said, "CurveBeam continues to elevate the standard of care for orthopedic extremity imaging, and introduction of the LineUP device is another solid step upwards."

INSIGHTEC Submits Pre-market Approval to Japanese PMDA of MR-guided Focused Ultrasound Surgery for Treatment of Parkinson’s Disease

5/14/18: "INSIGHTEC is committed to supporting research that extends the applications and potential of focused ultrasound, to improve the lives of people living with Parkinson's disease with a much less invasive approach than conventional surgery," commented Maurice R. Ferré MD, INSIGHTEC'S CEO and Chairman of the Board of Directors.

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