“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.
Mayo Clinic News Network/ — In a review published in Cancers, the researchers note that this emerging class of AI offers an innovative way to use massive datasets to help discover the complex causes of diseases such as cancer and improve treatment strategies.
While the MedTech industry continues to face significant challenges related to regulatory requirements, cybersecurity issues, recalls and lawsuits, leaders in the industry are navigating and overcoming these areas to push innovation forward like never before.
Ashwini Sharan, M.D., Chief Medical Officer of the Neuromodulation Division at Medtronic, discusses the development of the company’s recently CE Marked Inceptiv closed-loop spinal cord stimulator system for chronic pain and how the company plans to further incorporate closed loop technologies in its neuromodulation pipeline.
How to choose the right sterilization method for silicone-based medical devices and a look at novel silicone technologies.
A new survey from Frost & Sullivan highlights the key barriers to adoption of real world data and analytics in health care and life sciences.
Vladimir A. Makatsaria, who most recently served as Company Group Chairman at Johnson & Johnson MedTech, leading its global Ethicon surgery business, has been appointed CEO of global medical technology company LivaNova. Former CEO Bill Kozy will serve a Board Chair.
The Digital Medicine Society (DiMe) is partnering with PHTI, ZS, and other leading organizations to develop and launch core components of integrated evidence plans for digital health products to support faster regulatory approval and commercialization.
In his new role, Kesavan will assume responsibility for leading CitiusTech’s global delivery organization. This will encompass enhancing practice capability, service delivery maturity, market innovation to drive profitable business growth by collaborating across practices, markets, delivery and functions.
The National Institute of Standards and Technology (NIST) is seeking input from industry to support its response to President Biden’s Executive Order on AI. Comments, which are due February 2, 2024, will help NIST develop guidelines for evaluation and red-teaming, consensus-based standards and more.
