Month: June 2024

The Federal Food, Drug and Cosmetic Act prohibits facilities from denying, delaying or limiting FDA inspections in order to prevent their products from being considered adulterated. This policy has been in place for drug facilities since 2012, but was only extended to medical devices in 2017. The FDA has recently finalized a revision to its […]

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Akili Interactive, a company known for its video game treatment for attention deficit hyperactivity disorder (ADHD), is facing challenges as it struggles with sluggish sales. In response to this, the company has announced that it will lay off 46% of its staff and explore strategic alternatives. This decision comes after other digital therapeutics companies, such […]

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The Food and Drug Administration has announced a recall of Tandem Diabetes Care’s insulin pumps due to a software error that causes the pumps to shut down unexpectedly. This has affected at least 224 diabetes patients, with the potential to be life-threatening if the shutdown occurs while the person is sleeping. The bug in the […]

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The Biden administration has announced an increase in tariffs on imported products from China, including syringes, needles, and surgical gloves. These tariffs are intended to protect American workers and domestic manufacturers from China’s unfair trade practices and artificially low-priced exports. In addition to medical devices, tariffs will also be raised on $18 billion worth of […]

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Sarepta Therapeutics gene therapy, Elevidys, has received traditional FDA approval after failing its confirmatory test, expanding use to a wider group of Duchenne muscular dystrophy patients. The therapy works by producing a smaller version of dystrophin, a protein key to muscle function. The therapy was initially approved based on Phase 2 data showing micro-dystrophin production, […]

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Abbott’s dissolvable below-knee stent, originally designed for heart disease patients, is now being used in patients with severe vascular disease. The stent widens clogged blood vessels and then dissolves into the vessel’s walls over three years. It also delivers a drug to prevent scar tissue formation, a common issue with traditional metal stents. Abbott’s first […]

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The FDA is considering changes to its biosimilar policy, which could benefit companies that develop complex follow-on biologic drugs, clinicians who prescribe them, and the patients who receive them. Currently, pharmacists cannot substitute lower-cost biosimilars for brand-name products unless they are classified as interchangeable by the FDA. This requires additional clinical trials beyond those needed […]

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GE HealthCare and MediView XR have successfully implemented their co-developed OmnifyXR Interventional Suite System in a clinical setting. This system combines GE’s imaging technology with MediView’s augmented reality and surgical navigation platform to improve assessment of patient anatomy, enable informed clinical decision-making, and facilitate remote collaboration among care teams. The platform allows for displaying up […]

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