Freespira’s Strategic Approach to Market Access

Freespira, Inc. developed an innovative digital therapeutic treatment to address the need for accessible and effective solutions for panic disorder, panic attacks, and post-traumatic stress disorder (PTSD). As the first FDA-cleared, medication-free, at-home treatment, Freespira stands out in the crowded landscape of digital therapeutics, overcoming the limitations of traditional treatments.

Insights from the MDIC Excellence in Quality Summit

The MDIC Excellence in Quality Summit brought together industry leaders, regulatory authorities, and quality professionals, all committed to advancing quality practices throughout the medical device lifecycle. Over two days, the Summit explored innovative strategies and shared insights that emphasized the critical importance of integrating a culture of quality within organizations, harnessing advanced technologies, and continually striving for improvement.

Latest Clearance Success for Intuitive Powered by NEST Mark

The NEST Mark initiative which is being developed by the National Evaluation System for health Technology (NEST) has succeeded in empowering yet another efficient and streamlined path to FDA clearance for Intuitive labeling modification for its previously cleared robotic-assisted surgical devices (RASD) da Vinci Xi and X Surgical Systems.