Category: Artificial Intelligence

The FDA has declared a Final Rule to phase out the enforcement discretion for laboratory developed tests (LDTs), aligning them with the regulatory framework applied to in vitro diagnostics (IVDs). This change, to be published in the Federal Register on May 6, 2024, and available in a PDF version beforehand, signifies a significant shift for […]

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As of now, I’m unable to access the full content of the article titled “BY AMANDA CONTI” as the provided text seems to be part of a prompt or introduction inviting readers to fill out a form to access the entire piece. Based on the given excerpt, the article discusses a new question-and-answer draft guidance […]

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Failure Mode and Effects Analysis (FMEA) is a method commonly used to identify potential failures in a product or process design. However, in specialized fields like MedTech, FMEA is not the ideal risk management tool. MedTech primarily relies on ISO 14971:2019, which outlines risk management for medical devices. This article explores the differences between FMEA […]

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The FDA’s Center for Devices and Radiological Health has entered into a partnership with the Bill and Melinda Gates Foundation to enhance diagnostic development, supported by a $1.9 million grant from the Gates Foundation. This collaboration aims to devise novel analytical methods geared towards the advancement of breath-based diagnostic tools specifically designed for diseases prevalent […]

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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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