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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.

FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer

The FDA is alerting people recommended for breast cancer screening, and health care providers that thermography is not an alternative to mammography and should not replace mammography for breast cancer screening or diagnosis.
Recommendations for People Getting Breast Cancer Screenings:
  • Be aware that thermography is not a substitute for mammography and should not be used for breast cancer screening or diagnosis.
  • Have regular mammograms according to screening guidelines or as recommended by your health care provider.
  • Follow your health care provider’s recommendations for additional steps to diagnose breast cancer, such as a clinical breast exam, other breast imaging (for example, breast ultrasounds or MRI), or breast tissue biopsy.

Read the FDA’s Safety Communication

Mammography is the only screening method proven to reduce deaths from breast cancer through earlier detection.

There is no valid scientific data to show that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition including the early detection of breast cancer or other diseases and health conditions.

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