Tag Archives: Compliance

Alcon, a prominent player in eye care, has finalized its acquisition of glaucoma device maker Belkin Vision. Announced on a Monday, the purchase involves an upfront payment of $81 million with additional milestone payments potentially totaling up to $385 million. This deal grants Alcon ownership of innovative laser technology geared towards the treatment of open-angle […]

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Eli Lilly has successfully obtained FDA approval for its Alzheimer’s disease medication, Kisunla, a drug with similar therapeutic mechanisms to Eisai’s Alzheimer’s treatment but offers distinct dosing benefits that may attract patient preference. This approval follows unanimous support from an FDA advisory committee, recognizing Kisunla’s capability in decelerating cognitive decline outweighs its associated safety risks. […]

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On January 31, 2024, the FDA introduced the Final Rule for the new Quality Management System Regulation (QMSR), set to replace the existing Quality System Regulation (QSR) to align with ISO 13485:2016, which is the international standard for medical device quality management systems. This alignment aims to standardize good manufacturing practice (cGMP) requirements globally, a […]

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Merit Medical Systems recently announced the acquisition of the Esophyx Z+ acid reflux treatment from Endogastric Solutions for a sum of $105 million, showing its strategic commitment to expanding its portfolio in the gastrointestinal device market. Esophyx Z+, a minimally invasive device, targets gastroesophageal reflux disease (GERD), a condition affecting approximately 20% of the U.S. […]

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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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