Nearly 2/3 of device makers say their regulatory intelligence may be insufficient and they lack the resources to complete all product compliance needs this year. See the executive summary of this MedTech Intelligence audience research.
As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.
The call for abstracts for the MTI Regulatory Intelligence and Networking Summit is now open. The Summit, which will be held June 3-5, 2024, Washington, DC, offers education and discussion for the Medtech community as it works to develop processes, procedures and solutions to streamline global and product lifecycle regulatory compliance.
The draft guidance includes regulatory context in which use of real world evidence (RWE) may be appropriate, general considerations for the use of RWE, guidance on assessing data relevance and reliability, and considerations for methodologies for collection and analysis of real world data (RWD) to generate RWE.
Class 1 recalls are at a 15-year high. To reduce the number of recalls and nonconformances, medtech manufacturers need quality management and traceability processes that go beyond documenting and tracking changes to effectively connect people, processes and data.
This week Huma Therapeutics received FDA Class II 510(k) clearance for its Software as a Medical Device (SaMD) platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with Kaushik Gune, U.S. Head of Healthcare at Huma, about the current state of digital health technologies, the value of partnerships to enhance the use of real world data and how digital health is likely to advance in the coming years.
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.
The FDA has granted several exemptions to its Medical Device Reporting requirements related to events identified in certain real-world data sources, such as medical device registries.
The competition will explore the feasibility, resources and infrastructure needed to integrate real-world healthcare system data into AHRQ’s systematic review findings to improve healthcare practice. The top award winner could earn up to $200,000.
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.
