This exemption of certain unclassified medical devices from 510(k) requirements aims to achieve two goals: decrease regulatory burdens on the medical device industry and reduce costs required to comply with federal regulations, while allowing patients continued access to medical devices.

The price for a drug that treats Lambert-Eaton Myasthenic Syndrome (LEMS), a rare neuromuscular disorder that impacts strength and impairs walking, went from cost-free to the price of a house—$375,000 to be exact. 

The American Society of Radiologic Technologists (ASRT) has shown support for new licensure bills introduced in Missouri and Oklahoma.

The Medical Imaging & Technology Alliance (MITA) has released a new white paper outlining the differences between servicing and remanufacturing activities for medical imaging devices, urging the FDA to clarify its own definitions of the two terms. 

Approximately two-thirds of U.S.-based hospitals and acute-care facility leaders believe diagnosis-related group (DRG) optimization is still a problem that needs to be solved in revenue cycle management, according to a recent survey conducted by BESLER and HIMSS Media.

A contract dispute between Chattanooga, Tennessee-based Erlanger Health System and Tennessee Interventional and Imaging Associates (TIAA) is threatening to upend the hospital’s premiere stroke program, according to documents obtained by the Times Free Press.

The FDA has published a new letter to providers in radiology, pathology, emergency medicine and several other specialties with updated information related to breast implant associated-anaplastic large cell lymphoma (BIA-ALCL).

New Mexico Gov. Michelle Lujan Grisham has signed the state’s breast density reporting legislation into law.