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De novo classification

Anumana & Pfizer Partner on Amyloidosis AI-ECG Algorithm Development

by Fred Pennic 12/15/2022 Leave a Comment

Anumana & Pfizer Partner on Amyloidosis AI-ECG Algorithm Development

What You Should Know: - Anumana, an AI-driven health technology company and portfolio company of nference, today announced a multi-year agreement with Pfizer for Anumana to develop an investigational artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early identification of patients who may be at risk of cardiac amyloidosis. - Anumana will conduct a clinical validation trial and pursue De Novo classification for the algorithm as a
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ResApp Awarded CE Mark for Smartphone-Based Diagnostic Test for Respiratory Disease

by Fred Pennic 08/23/2019 Leave a Comment

ResApp Awarded CE Mark for Smartphone-Based Diagnostic Test for Respiratory Disease

ResApp Health, the developers of the world’s first smartphone-based diagnostic test for respiratory disease where one simply coughs into the phone and the machine learning-based algorithm diagnoses the underlying respiratory disease, has received CE Mark certification as a Class IIa medical device.Significance of CE Mark CertificationCE Mark certification indicates that ResAppDx-EU meets the essential requirements of all the applicable European regulations as a medical device and allows for the
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Philips Awarded FDA Clearance for Digital Pathology Solution for Primary Diagnostic Use

by Jasmine Pennic 04/13/2017 Leave a Comment

Massachusetts General Hospital Launches Digital Pathology Study

Today, Philips announced it has received regulatory clearance from the FDA (via De Novo classification) for its IntelliSite Pathology Solution, marking a significant leap forward for the pathology services industry in the U.S.  De novo classification is the regulatory pathway for marketing clearance for novel, low- to moderate-risk medical devices that are the first of their kindAs the first and only digital pathology system to be approved for primary diagnostic use in the country, today’s news
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