Before product developers can more confidently design RWE studies and venture away from the traditional path of lengthy prospective studies, industry must overcome several challenges. This article provides insight on these barriers and perspective on how industry might fully realize the promise of RWE in the near-term to advance health care.
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.
Is technology replacing the human element in hospitals and clinics, or enhancing it? In this AAMI Research Review, a pair of newly published studies exemplify how accounting for the humans that use a technology can enhance its effectiveness… and vice versa.
The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022.
Balwani was charged with 10 counts of wire fraud and two counts of conspiracy to commit wire fraud for misleading investors.
The committee will be discussing skin lesion analyzer technology and its application in detecting skin cancers in various patient care settings as well as the potential reclassification of approved computer-aided melanoma detection class III devices.
Guidance includes information about what’s protected—and what is not—when using period trackers and other health information apps on smartphones.
The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal of clarifying the requirements for market actors and protecting EU patients.
Standalone best-of-breed Enterprise Asset Management (EAM) systems have historically been leveraged to help solve the transactional needs of clinical engineering, IT and facilities. Yet few organizations are currently capitalizing on the wealth of data generated from these systems. In this article, we’ll examine some of these opportunities and offers suggestions as the industry begins developing our “next generation” of EAM systems.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to concerns raised by medical device trade associations regarding future regulation of medical devices in the United Kingdom.
