Medical Devices; Laboratory Developed Tests, a rule by the Food and Drug Administration was published on the Federal Register on 05/06/2024. The rule is effective July 5, 2024.Continue reading
Category Archives: AZBio News
SynCardia Total Artificial Heart Saves Another Life at Cincinnati Children’s
Implant Marks Over 2080 Total SynCardia Total Artificial Heart CasesContinue reading
Sensitive and Specific: Special Report on FDA final rule on LDTs
This week, the FDA released its long-awaited final rule on the regulation of laboratory-developed tests (LDTs).
Along with the rule, the agency published drafts of two guidance documents covering its enforcement policy for LDTs that are created “for immediate response to an emergent situation, such as an outbreak of an infectious disease.” One document covers enforcement when a public-health emergency hasn’t yet been declared; the other covers enforcement once the nation is in an official public-health emergency. Continue reading
CommonSpirit Health Appoints Anthony Houston President of its Arizona Market
PHOENIX (May 1, 2024) – CommonSpirit Health, the parent organization of Dignity Health, has named Anthony Houston, EdD, FACHE, president of its Arizona market. The organization’s Arizona market comprises eight acute care hospitals, a medical group, graduate medical education programs, imaging centers, specialty hospitals, urgent cares, freestanding emergency departments, insurance providers, an accountable care organization and other clinical partnerships. Houston will begin his duties this summer. Continue reading
New Video Explains the Impact of The Bayh Dole Act on American Innovation
Bayh-Dole Coalition Launches Campaign Against Proposed March-in Framework.
From Diagnosis to Advocacy: Layne Oliff’s Unwavering Commitment to ALS Awareness and Action
By Alexander Diegel
Layne Oliff was an active runner who successfully completed 10-mile trail runs up until his 60th birthday — before he was diagnosed with amyotrophic lateral sclerosis (ALS) in November of 2020. Layne soon pivoted that same drive and commitment to another journey, as an active advocate in the ALS community.Continue reading
GT Medical Technologies, Inc. and Theragenics Corporation Forge Distribution Partnership for Cesium-131
Extending Beyond Brain Tumors, Empowering Patients with Treatment Options in Prostate Cancer and Other MalignanciesContinue reading
FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests
[FDA Press Release, April 29, 2024 ]Today , the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years. Continue reading
AdvaMed Statement on the Release of FDA Rule on Laboratory-Developed Tests
April 29, 2024, WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, released the following statements from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s final rule for Laboratory Developed Tests (LDTs):
BioLab Sciences Celebrates 6 Year Anniversary and Cuts the Ribbon on New Facility in Mesa
BioLab Sciences, an Arizona life science company with a mission to manufacture reliable and safe products with the highest quality to help optimize body performance through continuous innovation, education, superior customer service, and teamwork celebrated its 6th anniversary as it cut the ribbon on its new manufacturing facility in Mesa, Arizona.Continue reading