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Artificial intelligence continues to capture the attention of lawmakers and regulators not only as an important focus of oversight, but also as a tool to be harnessed to help perform such oversight. We look at some key AI items captured by Pathways Document Depot over the past two months.
Sequel Med Tech, in collaboration with DEKA Research & Development, is preparing to launch the twiist automated insulin delivery system, a novel device that employs a “fundamentally different” mechanism of insulin delivery and is the first FDA-cleared AID to utilize Tidepool’s Loop algorithm. Although diabetes is the company’s first target, it has larger plans in the drug-delivery space.
The agency has opened a coverage analysis for the CardioMEMS sensor. Excerpted from Pathways’ Pick May 1 LDT Rule, AdComm Feedback, CardioMEMS Coverage, and Global Picks.