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Neal I Muni

Publications and source records attributed to Neal I Muni.

6 recordsLinked to original sources
PubMed2004

Regulatory issues for computerized electrocardiographic devices.

Computerized electrocardiogram (ECG) devices are regulated in the U.S. by the FDA Center for Devices and Radiological Health (CDRH). This article aims to highlight the salient points of the FDA regulatory review process, including the important distinction between a "tool" claim and a "clinical" claim in the intended use of a computerized ECG device. Specifically, a tool claim relates to the ability of the device to accurately measure a certain ECG parameter, such as T-wave alternans (TWA), while a clinical claim imputes a particular health hazard associated with the identified parameter, such as increased risk of ventricular tachyarrhythmia or sudden death. Given that both types of claims are equally important and receive the same regulatory scrutiny, the manufacturer of a new ECG diagnostic device should consider the distinction and regulatory pathways for approval between the two types of claims discussed in this paper.

Death, Sudden, Cardiac↗
PubMedDate not supplied

Integrating the patient's perspective into device evaluation trials.

Innovations in medical device technology have greatly expanded the range of therapeutic options available to physicians and their patients. The understanding of treatment effects from the patient's perspective is an essential component of a comprehensive assessment of any new therapy, including medical devices. The term "patient-reported outcomes" (PROs) has been growing in use to refer to a cluster of variables such as health-related quality of life, symptoms, physical functioning, psychological well-being, treatment satisfaction, and treatment preferences. As in drug trials, the use of PROs in device evaluation has several methodological challenges, ranging from general concerns about interpretation, to more specific issues related to study design and regulatory approval (use of PROs as primary end points, incorporation in labeling, and product promotion). Successful approaches for integrating PROs into device evaluation trials include the careful selection of appropriate, interpretable PRO end points, accounting for possible confounding factors, and the use of alternatives to placebo-controlled trial designs, such as single-arm pre-post, observational, and registry studies, when the use of placebo control groups is not feasible. This article discusses the potential value and difficulties in measuring PROs in device studies.

Clinical Trials as Topic↗