AMC Health has obtained its third FDA 510(k) clearance for its virtual care and clinical decision support platform, signifying its recognition as a Class II software medical device. This expanded clearance encompasses both the clinician dashboard and the patient mobile application, facilitating hospital-level, acute-care-at-home services and continuous monitoring through devices like continuous glucose monitors and other wearables.
A key feature of this clearance is the integration of AMC Health's proprietary, machine-learning-based risk prediction algorithms. These algorithms are designed to accurately forecast the risk of emergency department visits, hospitalizations, or mortality without intervention. The predictions are grounded in over 20 years of data derived from hundreds of millions of real-time patient interactions.
According to Jon Shankman, AMC Health’s Chief Analytics Officer, the company's data science team is making significant strides with its extensive collection of real-time data. He emphasized that this FDA clearance reflects the company's commitment to high standards and the quality of work delivered to its partners. Shankman also noted that their advanced analytics can identify precursors to chronic disease, enabling proactive planning for HEDIS Quality Measures and Risk Adjustment.
By adhering to the FDA's stringent standards, AMC Health aims to reinforce its dedication to delivering secure and effective virtual care solutions. Coupled with its HITRUST certification, AMC Health ensures robust security and compliance, providing health plans with confidence in managing vulnerable populations within the current regulatory landscape. AMC Health's virtual care approach addresses medical, mental, and social needs, leveraging real-time data to provide actionable insights. This approach aims to improve patient outcomes and quality, reduce costs, increase reimbursement, and expand access to care.
