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Latest From Medtronic PLC

PMA Supplement Studies Weak, Study Finds, As Past FDA Chief Califf Calls For More Rigor

The quality of studies used to support panel-track PMA supplement approvals need upgrading, as fewer than half were randomized, blinded or controlled and many relied on surrogate endpoints, says a study published in JAMA. In an accompanying editorial, former FDA commissioner Robert Califf, says it "raises concerns" that the US regulatory system has gotten "too permissive."

Clinical Trials Regulation

India Strikes Pricing Blow To Knees After Stent Cuts

Six months after imposing stiff price controls on cardiac stents, India’s government slashed costs of knee implants by nearly 70%, saying the action was necessary to end “unethical profiteering.”

Orthopedics India

Could CMS Changes To Bundled Pay Models Stifle Medtechs' Value-Based Pay Plans?

The US Center for Medicare and Medicaid Services proposed downsizing its CJR joint replacement value-based payment model and outright canceling its cardiac procedure bundled payment model. Will the move discourage companies like Zimmer Biomet, Johnson & Johnson, and Medtronic, which have already invested in programs based on the value-based models?

Reimbursement Market Access

Zimmer Faces HHS Inspector General Subpoena

The orthopedics manufacturer announced in a recent filing that the US Health and Human Services watchdog has asked for a range of records related to health-care consulting arrangements.

Medical Device Orthopedics
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