The controversy over U.S. Medicare coverage of breakthrough devices is far from over as an administrative matter, but the House of Representatives is prepared to statutorily force the issue with a new bill that enjoys bipartisan support. The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 provides instant Medicare coverage upon FDA clearance or approval of the device, a feature of previous policy proposals that the CMS has found administratively problematic.
U.S. lawmakers have been busy writing to government agencies demanding answers and explanations on a range of issues, including drug shortages, gain-of-function research and thickets of duplicative patents that extend patent protection well beyond 20 years for some prescription drugs.
The U.S. FDA gave Bot Image Inc. a coveted threefer with 510(k) clearance for its Prostatid artificial intelligence (AI) software for detection, diagnosis and monitoring of prostate cancer using both standard MRI and a non-invasive bi-parametric MRI, which does not require a contrast agent.
The Biden administration’s budget proposal for the U.S. federal government’s 2024 fiscal year is undergoing the usual vetting in Congress, and one hearing each in the House and Senate suggest the proposal will gain little or no traction on Capitol Hill. However, supporters of the National Institutes of Health (NIH) may be cheered by the fact that one of President Biden’s own party, Rep. Rosa DeLauro (D-Conn.), blasted the proposal for offering only a 2% increase in the NIH budget, a sign that the agency will receive a substantial boost in monies yet again in FY 2024.
Illumina Inc. released Connected Insights in a beta version for the U.S., following its commercial release in other selected countries. Connected Insights, an assay-agnostic, cloud-based software designed to streamline interpretation and reporting across next-generation sequencing (NGS) types, was initially developed for somatic oncology applications, the system will shortly also support whole genome sequencing for rare diseases.
Preparing for next month’s launch of the first U.S. FDA-approved therapy for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare disease only identified 10 years ago, Pharming Group NV disclosed pricing for the newly branded Joenja (leniolisib) of $750 per tablet, or $547,500 per year.
A lot of eyes and ears were tuned to the U.S. Supreme Court’s March 27 argument in Amgen Inc. v. Sanofi SA with its focus on how much enablement is necessary in broad genus patent claims.
The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices.
Concerns voiced during January’s U.S. FDA advisory committee meeting failed to deter Cidara Therapeutics Inc. from winning approval by the agency March 22 for once-weekly Rezzayo (rezafungin for injection) to treat a pair of indications – candidemia as well as invasive candidiasis (IC) – in adults with limited or no alternatives.
Surgvision GmbH received U.S. FDA 510(k) clearance for the Explorer Air II which will be deployed with pafolacianine, during intraoperative fluorescence imaging. The Explorer Air II will support surgeons in their battle to fight cancer, especially in cases of incomplete resection, as paired with pafolacianine, an imaging agent, it will help them improve tumor visualization and outcomes.
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