In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop and apply innovative approaches to the regulation of medical device software and other digital health technologies, on January 12, 2021, the Agency released their first Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD) Action Plan.
In step with the Breakthrough Devices Program, and the Agency’s promise to introduce additional programs that promote earlier access to life-changing devices, the U.S. FDA introduced the Safer Technologies Program (“STeP”) on January 6, 2021. The FDA’s latest program is intended for 510(k), De Novo or PMA devices that do not meet Breakthrough Devices Program criteria, but still have an important role in the treatment of lesser life-threatening or debilitating diseases/conditions and bring significant benefits to patients.
NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of New York-based CRO, Syntactx. This acquisition follows independent healthcare investment firm ArchiMed’s majority interest purchase of NAMSA in September 2020.