Multi-stakeholder event will focus on national innovation ecosystem for pediatric medical device development

TUCSON, Ariz., January 14, 2021 — The Critical Path Institute (C-Path) in collaboration with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), AdvaMed, the American Academy of Pediatrics (AAP) and multiple pediatric health system leaders, is proud to announce the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) Virtual Workshop to be held on February 9-11, 2021. The workshop will focus on the acceleration of medical device development for the unique needs of children.

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The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products¹ that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.

Learn about the  Safer Technologies Program for Medical Devices (STeP) program 

• View the Final Guidance Document
• View The Federal Register Posting
• Submit Comments 

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Researchers from the University of Arizona College of Medicine ­– Phoenix and Indiana University School of Medicine have developed a new diagnostic tool to better predict the likelihood of premature birth and neonatal morbidity in the early stages of pregnancy, which may increase care and outcomes for both baby and mother.
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University of Arizona Health Sciences faculty member Laurence Hurley, PhD, professor emeritus in the College of Pharmacy, has been elected as fellow of the National Academy of Inventors (NAI). The NAI Fellows Program highlights academic inventors who have demonstrated a spirit of innovation in creating or facilitating outstanding inventions that have made a tangible impact on quality of life, economic development and the welfare of society.Continue reading→

SCOTTSDALE, AZ — January 12, 2021 — Life365 has been named a winner in the 2021 BIG Innovation Awards presented by the Business Intelligence Group. Continue reading→

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• uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis aid pathologists in providing faster, more accurate patient diagnoses in breast cancer
• In combination with the VENTANA DP 200 slide scanner and Roche uPath enterprise software, the new algorithms provide innovative digital pathology solutions to advance personalised healthcare
• Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year.¹ About 15 to 20 percent of women diagnosed with breast cancer are HER2 positive.²

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