The latest global regulatory news, changes and updates affecting medical devices and technologies, including: DOJ arraigns test maker for investor fraud.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beroni Group, Canon Medical, Scone Medical Solutions.
Keeping you up to date on recent developments in cardiology, including: Biomarkers can forecast the development of incident heart failure; Mouse model helps researchers find MAARS lncRNA; Heart disease deaths rise in age of COVID-19.
Researchers at Thomas Jefferson University have found that using ultrasound to pop microbubbles already present in a contrast agent nearly doubled liver tumor response to transarterial radioembolization. The procedure raised no safety concerns and increased the likelihood of patients receiving a liver transplant.
Eyenovia Inc., a clinical-stage ophthalmic biopharmaceutical firm, has launched a phase III trial of its on-demand treatment for presbyopia, an age-related worsening in near vision. The treatment, called Microline, is a proprietary formulation of pilocarpine delivered via a microdosing dispenser.
PERTH, Australia – Researchers at the QIMR Berghofer Medical Research Institute in Queensland have developed a way of testing whether COVID-19 patients’ immune systems are gearing up to fight the virus that causes the disease.
False Claims Act (FCA) litigation is one of the more potent weapons used to corral life sciences companies that stray out of legal bounds in the U.S. Jaime Jones, a partner in the Chicago office of Sidley Austin LLP, told BioWorld that Sen. Chuck Grassley (R-Iowa), long a legislative watchdog, has several notions about how the statute might be tweaked.
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