AdvaMed - Advanced Medical Technology Association

31/07/2024 | Press release | Distributed by Public on 01/08/2024 21:48

Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening

Press Releases

Guardant Health's Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's Shield™ blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. It is the first blood test to be approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage.

Read more.

Related Reading

Event / Digital Health / Regulatory Affairs

AdvaMed Cybersecurity Summit

November 13, 2024
8:15 AM - 6:00 PM

Resource / Regulatory Affairs

MedTech Reimbursement Playbook

July 17, 2024

Resource / Regulatory Affairs

Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development

April 12, 2024

Resource / Regulatory Affairs

PFAS in Medtech

March 8, 2024

News / Ethylene Oxide / Regulatory Affairs

AdvaMed Anticipates EtO Sterilization Rule, Voices Concern About Impact on Patient Care

February 27, 2024

Resource / Regulatory Affairs

Artificial Intelligence in Medtech

February 21, 2024

Resource / Regulatory Affairs

Artificial Intelligence in Medical Technology Myths and Facts

February 21, 2024

Resource / Regulatory Affairs

Principles for Artificial Intelligence in Medical Technology

February 21, 2024

Call to Action…