Month: June 2024

The FDA’s waterfall diagram for design controls highlights the connection between design inputs and outputs through verification. It’s essential in the design controls process to ensure that the outputs meet the earlier specified inputs, essentially answering the question, "Did we build this device right?" Verification can often become problematic if there is haste in defining […]

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Cepheid, a medical diagnostics company, recently received de novo authorization from the U.S. Food and Drug Administration (FDA) for a groundbreaking molecular test designed to detect hepatitis C virus RNA directly from fingerstick blood samples. This marks the first test of its kind in the United States, uniquely positioning it at the forefront of hepatitis […]

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Alyve Health, an emerging player in the Indian digital health market, recently secured a substantial $5.5 million in Series A financing. This funding round was led by Axilor Ventures and saw participation from 1Crowd Fund, InHealth Ventures, and Trifecta Capital. Since its inception in 2020, Alyve Health has been on a mission to revolutionize personalized […]

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In a recent development dated June 28, 2024, a Philips spokesperson, Lu Yu, issued a statement contending the numbers of reported injuries and deaths cited by the FDA notice a day earlier regarding their bilevel positive airway pressure (BiPAP) machines, namely the A30 and A40 models. Philips acknowledges receiving reports of 10 serious injuries and […]

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The Food and Drug Administration (FDA) recently released a draft guidance aiming to improve the diversity of participants in clinical trials by establishing a framework for diversity action plans. This initiative, prompted by legislation passed by Congress in 2022, mandates that drug and device makers submit these plans to the FDA. The legislation set a […]

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On May 6, 2024, the FDA announced a Final Rule marking significant changes in the regulation of lab developed tests (LDTs). The new regulations classify in vitro diagnostics (IVDs) as devices, bringing them under FDA jurisdiction similarly to other medical devices, regardless of whether the manufacturer is a laboratory. This directive ends the previous enforcement […]

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Baxter has issued a recall for over 2,500 Life2000 ventilation systems in the United States due to the risk of the devices failing to charge or only intermittently charging. This recall has been categorized by the Food and Drug Administration (FDA) as a Class I event, which denotes the highest level of severity, according to […]

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On Thursday, the House Ways & Means Committee moved forward with four significant pieces of legislation aimed at enhancing Medicare coverage and modifying certain regulatory frameworks. These bills, passed with robust bipartisan support, address the inclusion of obesity drugs and cancer screening tests under Medicare and implement changes concerning Medicare’s discretion in the coverage of […]

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In Washington, there are ongoing developments concerning a federal rule that intends to simplify the reimbursement process for breakthrough medical devices. This rule is anticipated to be finalized early this summer according to Dora Hughes, the director of the clinical standards center at the Centers for Medicare and Medicaid Services (CMS). Hughes communicated this timeline […]

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A key investigational drug from Novo Nordisk, intended for the treatment of hypertension and chronic kidney disease, has failed to meet its goals in a critical Phase 3 trial. This outcome has consequently hindered the Danish pharmaceutical company’s ambitions to offer a new treatment alternative that hoped to surpass the safety and efficacy of existing […]

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