Using his new platform as chair of the U.S. Senate Health, Education, Labor and Pensions Committee, Sen. Bernie Sanders (I-Vt.) is again pushing the Biden administration to reinstate, and strengthen, a “reasonable pricing clause” in all future research agreements involving government agencies, especially those funding drug R&D.
U.S. federal authorities continue to wrap up cases in connection with COVID fraud, the latest of which yielded a $30 million fine for a single defendant accused of fraud and money laundering.
The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
The U.S. Environmental Protection Agency (EPA) has proposed a more stringent set of requirements for the use of ethylene oxide for sterilization of a variety of products, including medical devices, a proposal that is expected to increase the cost of operating these facilities.
Beneficiaries in the U.S. Medicare program have access to several technologies and procedures for treatment of glaucoma, but Medicare administrative contractors (MACs) seem to be looking sideways at some of these offerings. Both Wisconsin Physician Services and Palmetto GBA have floated draft local coverage proposals that deem procedures such as goniotomy and the combination of canaloplasty and trabeculectomy to be investigational, suggesting that claims for these and other services and devices will not be paid by these MACs.
The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.
GE Healthcare Technologies Inc. has launched Sonic DL, a deep learning technology designed to significantly accelerate magnetic resonance imaging (MRI) exams, after receiving regulatory clearance from the U.S. FDA.
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies.
They call it the world's “first fully integrated wearable” ultrasound system for evaluating cardiovascular function while you walk, run, even ride a bicycle. Built on the nanoengineering research at the University of California San Diego (UCSD) the wearable ultrasonic system-on-patch (USoP) employs machine learning to interpret deep tissue vital signs data and track subjects in motion.
Proponents of telehealth have been pressing Congress to statutorily broaden coverage of telehealth since before the COVID-19 pandemic, and the Telehealth Expansion Act of 2023 carries the weight of at least some of these expectations. The House Ways and Means Committee’s health subcommittee recently voted 30-12 to pass along the legislation to the full committee, but the bill operates principally to allow high-deductible health plans to cover telehealth benefits before the enrollee has met the deductible, leaving a substantial amount of telehealth terrain unaddressed.
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