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FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

WIDEBLUE DEVELOPS NEW SOFTCELL pH MONITOR

Wideblue, a multi-award winning product design, development and manufacturing consultancy, has developed a new medical device for Softcell Medical which measures and displays the pH of a patient’s tissue in real time during surgery.

This new pH monitoring system comprised of a pH probe and pH monitor has been developed to assist with the assessment of patients who have either sustained injuries, or have developed disease processes that make them susceptible to ischemia or localized tissue death. The pH probe enables a precise assessment of tissue pH, to help prevent the development of compartment syndrome or generalized tissue death. As with all diagnostic and monitoring devices, it should only be used as a guide to the clinician, who should use his or her clinical judgment in addition to the information provided by the pH system, to make the final decision concerning patient care.

Wideblue managing director, Russell Overend, commented: “Wideblue has developed and designed this highly accurate pH monitor for Softcell including ergonomic design, software design of the display screens and operation of the device, electronics design, manufacturing of the first units for clinical trials purposes plus production of the packaging, labels and instruction manual.

“The device works on the principle that if the blood supply is limited to parts of the body the organs/tissues become slightly acidic. The level of acid build up will guide the treatment of the patient.

The device is used before, during and after an operation to measure and display pH at various sites in the body to allow the surgeon to take appropriate action.”

Kirsty McIntosh, CEO of Softcell Medical said, “We are delighted to be working with Wideblue on this innovative project and would highly recommend them to other companies developing medical devices.”

For more information, visit www.wide-blue.com.

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