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Sunday, February 18, 2018

In the Spotlight

Study Shows Computer-Guided Insulin Dosing Plus More Frequent Blood Glucose Testing Leads to Better Outcomes for Patients with Diabetes

RCT Demonstrates a 71% Reduction in the Onset of Sacral Pressure Ulcers When Adding ALLEVYN◊ LIFE to Standard Preventative Protocol

Photocure Announces U.S. FDA Approval of New Indication for Blue Light Cystoscopy with Cysview®

New Pediatric At-Home Study of MiniMed (TM) 670G System Demonstrates Positive Results in Children Ages 7 to 13

Sentinel Cerebral Protection System Emerging as U.S. Standard of Care for Protecting the Brain from Risk of Stroke During Transcatheter Aortic Heart Valve Replacement

FDA Permits Marketing of Clinical Decision Support Software for Alerting Providers of a Potential Stroke in Patients

BREAKING MEDICAL DEVICE NEWS

Photocure Announces U.S. FDA Approval of New Indication for Blue Light Cystoscopy with Cysview®

2/16/18: Photocure ASA (OSE: PHO), announced today that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy (BLC™) with Cysview® to include Flexible Cystoscopes, which are used in the ongoing surveillance of patients with bladder cancer. This is the only combination of drug and device approved for the detection of bladder cancer.

Enovate Medical Introduces Envoy Mobile EHR Workstation

2/15/18: Electronic health record (EHR) workstations have come a long way. Initially just a computer on a cart, today’s EHR workstations are sophisticated clinical tools. Enovate Medical’s new Envoy workstation takes this evolution to the next level. It is the first intelligent workstation designed to reduce nursing fatigue, enhance patient engagement, endure the rigors of hospital settings, and perform without interruption throughout a clinician’s shift.

Study Shows Computer-Guided Insulin Dosing Plus More Frequent Blood Glucose Testing Leads to Better Outcomes for Patients with Diabetes

2/15/18: A retrospective study being presented at the 11th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) observed that use of Glytec’s Glucommander™ Outpatient for insulin therapy management combined with blood glucose self-testing at least twice a day resulted in better patient outcomes, including a 3.0% absolute reduction in A1c and virtually no hypoglycemia (0.003%) less than 54 mg/dL.

RCT Demonstrates a 71% Reduction in the Onset of Sacral Pressure Ulcers When Adding ALLEVYN◊ LIFE to Standard Preventative Protocol

2/15/18: Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces the publication of a randomised controlled trial (RCT) demonstrating that the addition of ALLEVYN LIFE, Smith & Nephew’s leading multi-layer silicone adhesive foam dressing, to a standard care protocol significantly reduces the onset of pressure ulcers by 71% in elderly patients admitted to hospital for hip fracture1.

Reduced Time in Hypoglycemia Demonstrated in Tandem Diabetes Care’s Pivotal Trial for the t:slim X2 Insulin Pump with Predictive Low Glucose Suspend Feature; Data to be Presented at ATTD...

2/15/18: Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced positive results from a pivotal study of the t:slim X2™ Insulin Pump with Basal-IQ technology, a predictive low glucose suspend (PLGS) feature. Data showed that the system achieved the primary outcome of reducing time spent in hypoglycemia compared to sensor-augmented pump therapy alone. Details from the study are being presented today at the 11th Annual Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Vienna, Austria by Dr. Bruce Buckingham, Professor of Pediatric Endocrinology at Stanford University, and principal investigator of the PROLOG (PLGS for Reduction Of LOw Glucose) trial.

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