Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
The Trump administration released an action plan for AI, which includes an exports program for full-stack AI in areas such as health care. The announcement drew the support of the Advanced Medical Technology Association, which described the initiative as an accelerant for the use of AI in health care and a boon to patient outcomes.
New guidance by the Medical Device Coordination Group spells out many of the routine aspects of compliance with the In Vitro Diagnostic Regulation, but test developers should remain aware of the tripwires in connection with modifications to both the test and the test’s performance studies.
There are times when a casual observer can’t tell whether the medical device industry’s messaging is getting through to policymakers, but a July 17 announcement by the Trump administration clearly signals the effectiveness of at least one med tech messaging strategy.
The U.S. organ donation system is once again under pressure from both the executive and legislative branches thanks to media reports detailing an instance in which a surgeon refused to harvest organs from a potential donor who had not expired.
The U.K. Medicines and Healthcare Products Regulatory Agency unveiled another round of measures designed to promote access to the latest medical technology, which includes a move to jettison domestic device markings in favor of unique device identifiers.
Australia’s Therapeutic Goods Administration proposed to adopt a 2021 EU guideline on quality documentation for drugs used with medical devices including co-packaged products, a demonstration of the impact of EU regulations on Australia’s own regulatory approach.
Palmetto GBA of Columbia, S.C., issued a draft local coverage determination that provides coverage for biomarker testing to stratify a patient’s risk associated with ductal carcinoma in situ.
The U.S. False Claims Act (FCA) is not the only statute governing the submission of false claims to federal agencies thanks to the more than 30 states with their own versions of the FCA. However, the federal government is providing states with more incentives to amplify their FCA-related activities, a development that raises the stakes for companies in the life sciences.
The U.S. Centers for Medicare & Medicaid Services (CMS) has issued a draft coverage memo for cardiac contractility modulation (CCM), which offers coverage with evidence development for the company’s Optimizer line of devices. CMS said it will issue the final coverage memo by Oct. 8, 2025, which will mark the achievement of an objective the company set for itself more than two decades ago.
