Emboline Inc., which is developing technology to reduce the chance of stroke during transcatheter heart procedures, completed a $10 million series C financing. The funds are earmarked to gain initial commercial approval of the company’s Emboliner device and to launch a U.S. pivotal study. The round, which included new and existing investors, follows a $5 million bridge round of financing that closed last January.
A New Year tradition in the U.S. is the inevitable price increase for a multitude of brand drugs. 2021 isn’t breaking with that tradition, despite American families being ravaged economically by nearly a year of the COVID-19 pandemic.
The U.S. FDA’s device center may still be grappling with the COVID-19 pandemic throughout the remainder of fiscal year 2021, but that does not mean other considerations have disappeared. The FDA’s Erin Keith said the agency will keep working on a major overhaul of the quality systems regulation (QSR) but will also work toward expanding industry’s use of advanced manufacturing technologies, such as additive manufacturing.
The U.S. Department of Health and Human Services (HHS) released an advisory opinion last week saying that drug manufacturers are obligated to provide 340B pricing for outpatient drugs dispensed by contract pharmacies on behalf of hospitals and clinics that qualify for the discounts. But the opinion said nothing about enforcement action or assessing civil penalties against manufacturers who refuse to do so.
Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.
A new rule intended to give drug manufacturers the flexibility they need to enter into value-based purchasing agreements with state Medicaid programs and commercial payers could end up hurting patients at the pharmacy counter in the U.S.
Telehealth has been topical in the U.S. for several years now, but the COVID-19 pandemic lent new urgency to the question of Medicare coverage. However, there are a number of related enforcement issues that could dampen adoption and increase the legal risk for both health care professionals and developers of telehealth-related products.
U.S. federal government enforcement of the Foreign Corrupt Practices Act (FCPA) might not draw the attention that other matters draw, but the Securities and Exchange Commission (SEC) has made extensive use of the FCPA in 2020. SEC actions related to the FCPA may have accounted for only about 2% of the agency’s actions over the past year, but nonetheless accounted for nearly 80% of the penalties collected by the agency, and health care was second only to the oil and gas industries as the targets of FCPA action by the agency.
Scientists at Duke University School of Medicine in Durham, N.C., have developed a small-molecule inhibitor of the cellular stress-protective transcription factor, heat-shock factor 1, which showed developmental promise against treatment-resistant prostate cancer and other cancers. The small molecule, Direct Targeted HSF1 InhiBitor (DTHIB), may also be a useful research tool for investigating the regulation and role of HSF1 in basic stress biology and in cancer.
Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.
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