As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are growing. These inaccuracies are already entering scientific literature, raising questions about reliability, compliance, and patient safety. Addressing this challenge requires more evidence-grounded AI and disciplined implementation.
Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, legal counsel, or executive leadership, with operations stepping in afterward to execute against decisions that have already been made, but that model is evolving as healthcare delivery becomes more interconnected and operationally complex, requiring administrators to engage earlier in the process, not only to understand what is being agreed to but to help define how those agreements will function in real-world environments.
Companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record and a publication bias that obscures the true landscape of drug development outcomes—overrepresenting successes and underrepresenting failures. This gap can also create a distorted perception of the safety and efficacy of medical products.
As organizations introduce additional technologies, including AI-enabled tools and CRM platforms, these gaps become more pronounced. Those that are seeing meaningful improvements are taking an end-to-end view, evaluating how systems interact within a unified workflow and ensuring that data flows seamlessly and actions are triggered in a coordinated manner, thereby reducing the need for manual intervention and follow-up.
Designed to expand treatment options for patients with cirrhosis and complications of portal hypertension, this next‑generation, adjustable‑diameter device represents the latest advancement by BD in interventional therapies addressing complex liver disease, according to the company.
Hologic announced the appointment of José (Joe) E. Almeida as Chief Executive Officer, effective immediately upon closing of the previously announced company acquisition.
In this part 2 of a 4-part series, Melissa highlight how the moment AI begins to influence decisions or workflows, it is operating within a regulated environment. Aligning with documentation standards, keeping data within established pathways, and ensuring actions are consistently recorded are all ways to support that reality early, rather than adapting to it later. Seen this way, integration is not just a technical milestone.
New technology designed to provide a single irrigation management system for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures.
The company's River stent will be available for adults with severe IIH – a debilitating, historically undertreated condition – who have failed medical therapy.
The acquisition expands Merit’s portfolio of therapeutic oncology products dedicated to the accurate diagnosis and localization of breast and soft tissue tumors.
New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas.
Geography is effectively determining whether patients receive timely cardiac diagnosis, or even any diagnosis at all. In an effort to address the problem, cardiologists and health systems are increasingly looking to cardiac CT to redefine how advanced imaging can be delivered closer to where patients live.
Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.
Patient Preference Information (PPI) guidance on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA.
Data highlights the WATCHMAN FLX device provided statistically superior protection from bleeding, demonstrated similar efficacy compared to blood thinners in patients with non-valvular atrial fibrillation. Findings presented at ACC.26 and simultaneously published in The New England Journal of Medicine.
