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Freespira’s Strategic Approach to Market Access: Paving the Way for Digital Therapeutics in Mental Health
Freespira’s Strategic Approach to Market Access: Paving the Way for Digital Therapeutics in Mental Health 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 […]
The Future is Here: Advanced Manufacturing in Medical Devices with Daniel Matlis
In an era characterized by unprecedented change and technological advancement, the message from industry leaders is clear: digital transformation is no longer optional but a critical necessity for survival and growth. In this MDIC Studio session, hear from Daniel Matlis, President and Founder of Axendia, as he describes the current state of advanced manufacturing in […]
Challenges and Barriers to the Adoption of Advanced Manufacturing in MedTech
MDIC Studio Panel: Challenges to Adopting Advanced Manufacturing in MedTech Join industry leaders Domhnall Caroll, CEO of Digital Manufacturing Ireland, Garth Conrad, Vice President of Quality at Flex Health Solutions, Daniel Matlis, CEO and Founder of Axendia, and Francisco Vicenty, Case for Quality Program Manager at the FDA CDRH in a compelling discussion on the […]
AMCH: Advancing Manufacturing Through Changing Perceptions
An Invitation to Join the Advanced Manufacturing Clearing House Evolution Are you ready to share your story of digital transformation? Join Joe Sapiente, Vice President of Clinical Science and Technology at MDIC, and Fransisco Vicenty, Program Manager for Case for Quality at the FDA, as they discuss the evolution of the Advanced Manufacturing Clearing House […]
The MDIC Commercial Payer Council: Fostering Collaboration for Enhanced Patient Access
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Video Series: Navigating the US Public Payer Reimbursement Landscape
Understanding the complexities of successfully navigating the reimbursement and coverage processes to commercialize disruptive medical technologies can often be a complicated endeavor for organizations. MDIC has partnered with leading industry experts to review key components of developing a successful reimbursement strategy in a new series of informational videos. These videos highlight how to achieve commercial […]
Medical Device Innovation Consortium Selects Simon Mason to Lead National Evaluation System for health Technology Coordinating Center
Senior health care executive moves to advance the role of real-world evidence in medical device ecosystem April 17, 2023 FOR IMMEDIATE RELEASE [Arlington, VA.] – The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has named Simon Mason as its new President. In his new […]
Use of Bayesian Decision Analysis to Maximize Value in Patient- Centered Randomized Clinical Trials in Parkinson’s Disease Released
MDIC Releases Landscape Report on Medical Device Computational Modeling and Simulation
ARLINGTON, Va., January 31, 2022 — The Medical Device Innovation Consortium (MDIC) released the “Landscape Report & Industry Survey on the Use of Computational modeling and Simulation (CM&S) in Medical Device Development”. This new report from MDIC discusses the potential of CM&S to reduce product development costs, speed up time to market, and better serve […]
MDIC Publishes First Landscape Analysis of 5G in Healthcare
MDIC’s new report surveys the role of 5G connectivity in current and future states of the healthcare continuum of care. The report highlights key challenges and knowledge gaps to help deliver the benefits of 5G in healthcare more safely to patients. ARLINGTON, Va. – The Medical Device Innovation Consortium (MDIC), has released the Landscape […]
MDIC Publishes White Paper on Using Patient Preference Information for Coverage Decision Making
ARLINGTON, VA (BUSINESS WIRE)—The Health Economics and Patient Value (HEPV) initiative at the Medical Device Innovation Consortium (MDIC) has released the white paper, How Can Patient Preference Information Be Used in Payer Coverage Decisions and Health Technology Assessment? As patients become more engaged with their care, healthcare stakeholders want to understand how to better incorporate […]
MDIC Curates: Weekly Industry News Round-Up (September 1st)
Medical Device Innovation Consortium Launches Initiative to Improve Accuracy of Next Generation Sequencing-Based Cancer Diagnostics
External Evidence Methods Framework Project earns CDRH Regulatory Science Excellence Award
Congratulations to Jithesh Veetil, PhD, awarded The CDRH Regulatory Science Excellence Award for for the External Evidence Methods (EEM) Framework Project. MDIC EEM Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Informed by a number of public forums and a survey of medical […]
Around the Web: Stakeholders seek tweaks to FDA’s voluntary improvement program guidance
Stakeholders seek tweaks to FDA’s voluntary improvement program guidance Regulatory NewsRegulatory News | 08 July 2022 | By Jeff Craven 3044 The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to […]
Around the Web: Calidi Biotherapeutics Announces FDA Authorization of IND for a Phase 1 Clinical Trial of NeuroNova in Patients with Recurrent High-Grade Glioma
LA JOLLA, Calif.–(BUSINESS WIRE)– Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, is pleased to announce that City of Hope has received U.S. Food and Drug Administration (FDA) authorization to proceed with a phase 1 physician-sponsored clinical trial that will use Calidi’s licensed oncolytic […]
Around the Web: iRhythm receives FDA clearance for ZEUS System for Zio watch
iRhythm Technologies has received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. Produced in partnership with Verily, an Alphabet precision health company, the ZEUS System combines deep learned algorithms with a proven and trusted cardiac arrhythmia service. The ZEUS System is the AI algorithm and solution component of the […]
Around the Web: The revolutionary portable ultrasound tech could transform the healthcare space
Ultrasounds are a huge milestone for a mother-to-be. It is a health check-up, a confusing picture, but most importantly a first chance to see the child with whom one will spend the rest of their life. It is also a huge hassle. In today’s age of overcrowded hospitals, highly infectious diseases and general uncertainty, just […]
EFS: EFS Working Groups Update 2 Key Resources
The Master Clinical Trial Agreement (MCTA) working group and Informed Consent and Institutional Review Board (ICF) working group within the Early Feasibility Studies (EFS) program have completed updates to two key EFS resources. Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an […]
FDA VIP Program Guidance Released
The Draft Guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program” was published today in the Federal Register for a 60-day public commenting period. “The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices […]
MDIC Publishes Framework on External Evidence Methods for Medical Devices
The Medical Device Innovation Consortium (MDIC), today announced the publication of the MDIC External Evidence Methods (EEM) Framework. This framework, developed by subject matter experts from industry, academia, and the U.S. Food and Drug Administration (FDA), is a document intended to help stakeholders navigate their way through the process of leveraging external data by harnessing […]