ARTICLE SUMMARY:
The top five Market Pathways articles posted in November to MyStrategist.com, chosen by readers and editors, include leveraging AI/machine learning to improve outcomes, Hawthorne Effects model for decentralized trials, Apple's Afib clearance, and our recurring columns FDA Output and Market Scorecard.
The top five Market Pathways November articles.
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#1: Unlocking the True Power of AI/ML-Based Medical Technology
What are the current limitations of AI/ML technology, and what must industry stakeholders do to fully leverage the technology's continuous learning capabilities to increasingly improve clinical outcomes? Global regulatory and standards bodies are harmonizing to get us closer to tapping this infinite potential, and manufacturers will play a critical role in bringing this powerful promise to fruition. By Sharon Murphy and Yuan Fang, Regulatory Affairs, Hologic Inc.
#2: Hawthorne Effect: A Distributed Model Reinvents Clinical Trials
In a large and growing class of tech companies operating in decentralized clinical trials, Hawthorne Effect differentiates itself with a heritage based on the complexities of medtech, and an Uber-like model that comes to the patient.
#3: Apple Wins FDA Clearance for Machine Learning-Based AFib Notification
The tech giant quietly gained a 510(k) clearance last month for an update to its Apple Watch arrhythmia notification feature. It’s the second 510(k) and fourth overall FDA authorization ever for Apple, which has been building up its internal health products regulatory affairs team since the firm's first submissions made it through the agency in 2018.
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in November 2021.
#5: Market Scorecard November 2021
Our monthly infographic of stats and facts for the medtech regulatory and policy community. This month: MDR and IVDR Guidance metrics, new CPT codes decline, and FDA approvals year-to-date.