Medtech Groups Lose Challenge to Digital Piracy Rule in Device Repair Case
A lawsuit that challenged a rule allowing third-party access to copyrighted software for equipment diagnosis and repairs has been dismissed.
A lawsuit that challenged a rule allowing third-party access to copyrighted software for equipment diagnosis and repairs has been dismissed.
In this Soapbox column, retired BMET manager Frank Nickells, CBET, shares his thoughts on the Right to Repair and reveals why he thinks the resistance to the movement is about money—not safety.
The Medical Imaging & Technology Alliance (MITA) has responded to the publication of the U.S. FDA’s guidance titled, “Remanufacturing of Medical Devices.”
A lawsuit that challenged a rule allowing third-party access to copyrighted software for equipment diagnosis and repairs has been dismissed.
The Alliance for Quality Medical Device Servicing, a group of six independent medical device service organizations, issued a statement expressing disappointment in the withdrawal of AdvaMed and MITA from the FDA-supported Medical Device Servicing Collaborative Communities.
Read MoreThe Medical Imaging & Technology Alliance (MITA) today applauded President Trump for signing a permanent repeal of the medical device tax into law.
Read MoreThe Medical Imaging & Technology Alliance (MITA) has commended U.S. lawmakers for including a permanent repeal of the medical device tax in the recently announced year-end government funding package.
Read MoreThe Medical Imaging & Technology Alliance (MITA) applauded a recent letter by U.S. senators Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) to acting U.S. FDA Chairman Ned Sharpless, MD, about the agency’s upcoming guidance clarifying the distinction between the “servicing” and “remanufacturing” of medical devices.
Read MoreThe Medical Imaging & Technology Alliance (MITA) has announced the publication of NEMA/MITA 2—Requirements for Servicing of Medical Imaging Equipment, a voluntary standard outlining MITA’s minimum quality management system requirements for medical imaging device servicing.
Read MoreThe Medical Imaging & Technology Alliance (MITA) has announced that Lisa Spellman has joined the organization as the general-secretary for the Digital Communications in Medicine (DICOM) international. In her role, Spellman will provide strategic leadership and manage operational affairs for DICOM stakeholders worldwide.
Read MoreThe Medical Imaging & Technology Alliance (MITA) announced that it is expanding the scope of the NEMA American National Standard for Servicing of Medical Imaging Devices to cover all medical devices, not just medical imaging technologies. MITA officials say this decision—which is likely to be met with criticism from many in the medical device sector—“comes after the consideration of extensive stakeholder feedback indicating a desire for one, universal standard for the medical device industry.”