Following a meeting at the MDIC Annual Public Forum, Maryellen de Mars, MDIC’s program director of clinical diagnostics, said in an interview that the consortium’s Somatic Reference Samples Initiative recently confirmed that it has successfully engineered the 10 target reference lines and is ready to start its next steps to confirm its results and establish use cases.
Category: News
APF 2024: Shaping the Future of Real-World Evidence and AI in Healthcare
The MDIC Annual Public Forum 2024 opened with impactful discussions led by experts from the National Evaluation System for health Technology (NEST), the Centers for Medicare and Medicaid Services (CMS), and the FDA, focusing on the future of real-world evidence (RWE) and the integration of AI into the healthcare ecosystem.
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.
Celebrating 15 Years of Leadership at FDA’s CDRH
One of Dr. Shuren’s enduring legacies is his co-founding of MDIC, which stands as a testament to his belief in collaboration. Under his guidance, MDIC has united regulators, medical device innovators, and healthcare stakeholders to advance clinical and regulatory science.
A Decade of Innovation in Medical Device Testing
Since its inception, the EFS program has supported device innovation and increased patient access to potentially beneficial new technologies. EFS allow investigators to gain early clinical experience with investigational devices, often to address unmet clinical needs, while incorporating enhanced risk mitigation strategies to protect patients.
NESTcc Partners with Booz Allen Hamilton for Active Surveillance in Medical Devices
NEST selects Booz Allen Hamilton to partner on the design and implementation of an active surveillance system using electronic health data to better understand the safety of medical devices as used within clinical practice.
Chip Hance Appointed as Chair of MDIC Board
Chip Hance assumed the position of Chair of the Board of Directors of the Medical Device Innovation Consortium (MDIC) at the organization’s most recent Board meeting. Hance, a longtime leader in the medical device field, reflected on the opportunities ahead for MDIC as he took over Board leadership from the outgoing chair, Dr. Jijo James, Chief Medical Officer, MedTech and External Innovation at Johnson and Johnson.
MDIC Launches Somatic Reference Samples Initiative for Cancer Diagnostics
The MDIC formally launched its Somatic Reference Samples (SRS) Initiative with a pilot project to improve the validation and regulatory review process for cancer diagnostics based on next-generation sequencing (NGS).