Publications by authors named "Kushal T Kadakia"

Article Synopsis
  • * Evidence from court documents shows that the Celect IVC filter’s clinical study did not adhere to FDA guidelines and had inadequate methods for detecting serious complications.
  • * The misreporting of adverse events and patient deaths raises concerns about the accuracy of safety information provided to both clinicians and patients, underlining a need for reform in medical device regulations.
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Article Synopsis
  • Nearly all medical devices in the U.S. are authorized through the FDA's 510(k) clearance process, which compares new devices to existing ones without requiring extensive safety evidence.
  • Supporters argue this process fosters innovation and quick access to market, while critics raise concerns about patient safety.
  • In September 2023, the FDA released guidance documents aimed at reforming this process, focusing on improving predicate selection, clinical testing standards, and regulations for implantable devices to enhance transparency and safety.
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Background: Cardiovascular devices account for one third of all Class I recalls, the U.S. Food and Drug Administration's (FDA) most severe designation, indicating a reasonable probability of "serious adverse health consequences or death.

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The U.S. Food and Drug Administration’s (FDA) recent authorization of DermaSensor, an AI-enabled device for skin cancer detection in primary care, marks a pivotal moment in digital health innovation.

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Diverse tumor metabolic phenotypes are influenced by the environment and genetic lesions. Whether these phenotypes extend to rhabdomyosarcoma (RMS) and how they might be leveraged to design new therapeutic approaches remains an open question. Thus, we utilized a Pax7; Nras; p53 (P7NP) murine model of sarcoma with mutations that most frequently occur in human embryonal RMS.

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Background: Medical device recalls are initiated in response to safety concerns. Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Recalled devices must be identified, assessed, and corrected or removed, upon which a recall can be terminated.

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Policy Points Cities, which are where the majority of the world's population lives today, directly and indirectly shape human health and well-being. Urban health research, policy, and practice are increasingly using a systems science approach to address the upstream and downstream drivers of health in cities, which include social and environmental factors, features of the built environment, conditions of living, and health care resources. To guide future scholarship and policy, we propose an urban health agenda for 2050 focused on revitalizing the sanitation movement, integrating data, scaling best practices, adopting the Health in All Policies approach, and addressing intraurban health inequities.

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Policy Points The predominantly fee-for-service reimbursement architecture of the US health care system contributes to waste and excess spending. While the past decade of payment reforms has galvanized the adoption of alternative payment models and generated moderate savings, uptake of truly population-based payment systems continues to lag, and interventions to date have had limited impact on care quality, outcomes, and health equity. To realize the promise of payment reforms as instruments for delivery system transformation, future policies for health care financing must focus on accelerating the diffusion of value-based payment, leveraging payments to redress inequities, and incentivizing partnerships with cross-sector entities to invest in the upstream drivers of health.

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Policy Points Accurate and reliable data systems are critical for delivering the essential services and foundational capabilities of public health for a 21 -century public health infrastructure. Chronic underfunding, workforce shortages, and operational silos limit the effectiveness of America's public health data systems, with the country's anemic response to COVID-19 highlighting the results of long-standing infrastructure gaps. As the public health sector begins an unprecedented data modernization effort, scholars and policymakers should ensure ongoing reforms are aligned with the five components of an ideal public health data system: outcomes and equity oriented, actionable, interoperable, collaborative, and grounded in a robust public health system.

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