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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De novo classification
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
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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