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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.

SunTech Medical Achieves ISO 13485 with MDSAP Certification

Clinical grade blood pressure device specialist SunTech Medical has successfully upgraded its ISO 13485 certification to include the Medical Device Single Audit Program (MDSAP) standard. ISO 13485 with MDSAP confirms that SunTech meets all regulatory requirements in the U.S., Canada, Brazil, Japan and Australia for medical device design and manufacturing.

Introduced in 2014, MDSAP certification requires that the recipient pass an extensive auditing process to prove its existing quality management system meets the requirements set forth by governing bodies in the U.S., Canada, Brazil, Japan and Australia for the design and manufacture of medical devices.

“We are proud to be one of the few companies who has successfully completed the MDSAP program,” SunTech Medical President Rob Sweitzer said. “The certification assures our customers that our manufacturing practices are among the best in the world.”

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