Double-digit growth of the company’s literature review software platform, DistillerSR, spurred $20 million in funding from the growth investment consortium led by Thomvest Ventures.
Companies can make mistakes during drug and device development and in the post-marketing maintenance phase, but all too often, organizations apply a temporary solution to the problem and move on. In this article, Helen Lowe at Arriello addresses how Corrective and Preventive Action (CAPA) management provides a better approach to discover the root cause of the problem.
The Experiential Learning Program (ELP) provides CDRH review staff with an opportunity to visit sites and gain a better understanding of the products they review. The 2023 ELP Site Visit Proposal period is open now until September 6, 2022.
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.
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.