Orbital Implants Receiving Food and Drug Administration Premarket Notification.

Purpose: This perspective explores the Food and Drug Administration (FDA) 510(k) program, occasionally referred to as premarket notification, which facilitates faster marketing of Class II medical devices, such as orbital implants by demonstrating "substantial equivalence" to previously approved devices. This allows for FDA clearance, rather than FDA approval of orbital implants via comparison to currently marketed implants rather than clinically proven safety standards.

Methods: Utilizing the FDA's publicly available 510(k) Premarket Notification database, we conducted a thorough search of FDA-cleared orbital implants dating back to the inception of the 510(k) process in 1976.

Brain tumor craniotomy outcomes for dual-eligible medicare and medicaid patients: a 10-year nationwide analysis.

Introduction: Dual-eligible (DE) patients, simultaneous Medicare and Medicaid beneficiaries, have been shown to have poorer clinical outcomes while incurring higher resource utilization. However, neurosurgical oncology outcomes for DE patients are poorly characterized. Accordingly, we examined the impact of DE status on perioperative outcomes following glioma, meningioma, or metastasis resection.

Health disparities attributed to Medicare-Medicaid dual-eligible status in patients with peripheral arterial disease.

Objective: Peripheral arterial disease (PAD) is a prevalent and debilitating disease that can be effectively treated by surgical revascularization. However, Medicare-Medicaid dual-eligible patients have experienced worse long-term outcomes, notably higher rates of amputation and mortality, relative to other insurance groups. In the present study, we investigated how insurance status can perpetuate health disparities in PAD outcomes.

Outcomes after clipping and endovascular coiling for aneurysmal subarachnoid hemorrhage among dual-eligible beneficiaries.

Dual-eligible beneficiaries, individuals with both Medicare and Medicaid coverage, represent a high-cost and vulnerable population; however, literature regarding outcomes is sparse. We characterized outcomes in dual-eligible beneficiaries treated for aneurysmal subarachnoid hemorrhage (aSAH) compared to Medicare only, Medicaid only, private insurance, and self-pay. A 10-year cross-sectional study of the National Inpatient Sample was conducted.