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Qscription Technologies and NEOPATHOLOGY CORP. Sign MOU to Bring FDA-Cleared Lung Imaging AI into U.S. Clinical Practice
EntSun News/11101943
Preliminary framework pairs NeoPathology's clinical network with Qscription's enterprise integration and U.S. operations capability.
MILWAUKEE - EntSun -- Qscription Technologies Inc., a U.S. market-entry and clinical AI integration company, and NEOPATHOLOGY CORP., a biotechnology research and clinical diagnostic development company, today announced a Memorandum of Understanding (MOU).
Under the preliminary framework, the companies intend to explore joint commercialization and enterprise integration of an FDA 510(k)-cleared lung imaging AI diagnostic application in select U.S. healthcare markets. NEOPATHOLOGY brings its clinical network, diagnostic expertise, and clinical onboarding capability. Qscription contributes enterprise integration and U.S. operations support.
Regulator-cleared AI applications frequently stall between clearance and everyday clinical use, held up by IT integration, security review, and onboarding complexity. Under the proposed framework, NEOPATHOLOGY would lead clinical strategy, including securing programs, clinical onboarding, and region-specific medical compliance. Qscription would lead enterprise integration through its MedTech Operations capability, including integration with provider PACS and EHR environments, in material compliance with applicable HIPAA Security Rule and FDA requirements.
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"Clinical AI does not fail on science. It fails on integration and adoption," said Anurag Velekkatt Sunil Kumar, VP, MedTech Partnerships at Qscription Technologies. "NeoPathology's clinical network and commercialization strength, combined with our enterprise integration and U.S. operations capability, make a complete offering for the providers we serve."
"Our mission at NEOPATHOLOGY has always been centered on delivering highly accurate, rapidly reported diagnostics that meaningfully improve patient outcomes," said Paul Aiyetan, M.D., M.S., Ph.D., CEO and Director of Research, Development and Translation at NEOPATHOLOGY CORP. "Securing regulatory clearance is a critical milestone, but it is not the finish line. This MOU represents our proactive approach to ensuring that breakthrough tools can be safely, compliantly, and efficiently integrated into the hands of providers. By pairing our clinical development depth with Qscription's technical deployment framework, we are charting a reliable course from validation to clinical adoption."
The companies are now working toward a definitive commercial deployment agreement.
About NEOPATHOLOGY CORP.
NEOPATHOLOGY CORP. is a biotechnology research and clinical diagnostic development company advancing highly accurate, rapidly reported precision tissue diagnostics, anchored by its proprietary diagnostics platform and ONEPATHOLOGY(TM) learning solution. NEOPATHOLOGY is a Delaware corporation headquartered in Frederick, Maryland. https://neopathology.bio
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About Qscription Technologies
Qscription Technologies is the U.S. market-entry partner for global MedTech and clinical AI companies. Through its Decipher(TM) framework, Qscription provides regulatory presence, market access, enterprise integration, and U.S. operations support, turning FDA-cleared products into adopted products. Qscription is a Delaware corporation headquartered in Jackson, Wisconsin. https://qscription.tech
Read more: https://qscription.tech/blog/qscription-neopathology-mou
Media contacts
Qscription: Ajeesh Kumar, CTO, +1 715 449 8977
NEOPATHOLOGY: Paul Aiyetan, M.D., M.S., Ph.D., +1 (202) 810 3614
Under the preliminary framework, the companies intend to explore joint commercialization and enterprise integration of an FDA 510(k)-cleared lung imaging AI diagnostic application in select U.S. healthcare markets. NEOPATHOLOGY brings its clinical network, diagnostic expertise, and clinical onboarding capability. Qscription contributes enterprise integration and U.S. operations support.
Regulator-cleared AI applications frequently stall between clearance and everyday clinical use, held up by IT integration, security review, and onboarding complexity. Under the proposed framework, NEOPATHOLOGY would lead clinical strategy, including securing programs, clinical onboarding, and region-specific medical compliance. Qscription would lead enterprise integration through its MedTech Operations capability, including integration with provider PACS and EHR environments, in material compliance with applicable HIPAA Security Rule and FDA requirements.
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"Clinical AI does not fail on science. It fails on integration and adoption," said Anurag Velekkatt Sunil Kumar, VP, MedTech Partnerships at Qscription Technologies. "NeoPathology's clinical network and commercialization strength, combined with our enterprise integration and U.S. operations capability, make a complete offering for the providers we serve."
"Our mission at NEOPATHOLOGY has always been centered on delivering highly accurate, rapidly reported diagnostics that meaningfully improve patient outcomes," said Paul Aiyetan, M.D., M.S., Ph.D., CEO and Director of Research, Development and Translation at NEOPATHOLOGY CORP. "Securing regulatory clearance is a critical milestone, but it is not the finish line. This MOU represents our proactive approach to ensuring that breakthrough tools can be safely, compliantly, and efficiently integrated into the hands of providers. By pairing our clinical development depth with Qscription's technical deployment framework, we are charting a reliable course from validation to clinical adoption."
The companies are now working toward a definitive commercial deployment agreement.
About NEOPATHOLOGY CORP.
NEOPATHOLOGY CORP. is a biotechnology research and clinical diagnostic development company advancing highly accurate, rapidly reported precision tissue diagnostics, anchored by its proprietary diagnostics platform and ONEPATHOLOGY(TM) learning solution. NEOPATHOLOGY is a Delaware corporation headquartered in Frederick, Maryland. https://neopathology.bio
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About Qscription Technologies
Qscription Technologies is the U.S. market-entry partner for global MedTech and clinical AI companies. Through its Decipher(TM) framework, Qscription provides regulatory presence, market access, enterprise integration, and U.S. operations support, turning FDA-cleared products into adopted products. Qscription is a Delaware corporation headquartered in Jackson, Wisconsin. https://qscription.tech
Read more: https://qscription.tech/blog/qscription-neopathology-mou
Media contacts
Qscription: Ajeesh Kumar, CTO, +1 715 449 8977
NEOPATHOLOGY: Paul Aiyetan, M.D., M.S., Ph.D., +1 (202) 810 3614
Source: Qscription Technologies Inc
Filed Under: Business
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