MDIC’s News Hub

August 20, 2024

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 […]

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 […]

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 […]

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 […]

April 4, 2024

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 […]

April 17, 2023

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 […]

March 17, 2023

January 31, 2023

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 […]

December 15, 2022

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 […]

December 6, 2022

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 […]

August 23, 2022

August 8, 2022

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 […]

August 8, 2022

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 […]

August 2, 2022

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 […]

August 1, 2022

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 […]

August 1, 2022

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 […]

June 1, 2022

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 […]

May 6, 2022

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 […]

May 5, 2022

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 […]