Law firm, Hogan Lovells, analyses the implications of the AI Act for the Medtech sector and highlight a number of key challenges for medical device manufacturers and their partners in aligning conformity routes for their products under the AI Act.
In a multi-year agreement, Zimmer Biomet will commercialize RevelAi Health’s patient care-management platform, care team dashboard for providers, and any future products or services.
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.
Payers demand robust evidence that molecular diagnostics and AI/ML technologies demonstrate clear ability to improve overall patient health or healthcare economics even if the technologies themselves don’t directly deliver the final outcome. This disconnect between a technology’s function and the desired long-term impact creates a hurdle for [innovators] to overcome when convincing payers of their value proposition.
Due to a shortage of radiologists and other imaging specialists, AI-enabled technologies are of significant interest—and hold particular promise—in medical imaging. In this article, Penny Pinnock of Siemens Financial Services (SFS), discusses the routes to investment available for healthcare organizations looking to acquire efficiency boosting technology while protecting their financial health.
Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s specific requirements. An appreciation of the unique considerations for artificial intelligence-enabled technologies is another essential component of an efficient and effective application.
“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.
A new survey from the Center for Connected Medicine at UPMC Sheds light on how healthcare systems are navigating both the promise and the possible risk of AI and generative AI.
Emerging technologies, integrated vendor ecosystems and enhanced regulatory compliance will redefine care delivery and shape the needs of healthcare stakeholders. Following are six healthcare technology trends that will shape care delivery and the MedTech market in 2024.
While AI is already making significant contributions to pre-operative planning and post-operative analysis, its utilization intra-operatively remains a key area for further development. Collecting and utilizing comprehensive intra-operative surgical data, as facilitated by innovative applications of existing technologies such as light field, will pave the way for advanced AI applications in spine surgery.
