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U.S. Food and Drug Administration Approves Expandable Heart Valve for Children from Edwards

U.S. Food and Drug Administration Approves Expandable Heart Valve for Children from Edwards

Edwards Lifesciences' Autus valve has received FDA approval, with the possibility of later expansion using a balloon catheter as the child grows, potentially reducing the need for repeated open-heart surgeries. The decision was based on a study involving 62 children, with follow-up planned for 10 years.

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U.S. Food and Drug Administration Opens Comment Period on 2027 Medical Device Guidance Priorities

U.S. Food and Drug Administration Opens Comment Period on 2027 Medical Device Guidance Priorities

The U.S. Food and Drug Administration identified the guidance lists that the Center for Devices and Radiological Health plans to publish or develop during fiscal year 2027 and opened a comment period through November 30, 2026. The plan includes lists of priorities, potential resources, and documents under development.

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Trump’s FDA Nominee Pledges to Follow the Law in Vaccine and Abortion Drug Decisions

Trump’s FDA Nominee Pledges to Follow the Law in Vaccine and Abortion Drug Decisions

Heidi Overton, Donald Trump’s nominee to lead the U.S. Food and Drug Administration, told the Senate that she would follow the law in decisions involving vaccines and the drug mifepristone, and pledged to accelerate early drug research and confront the rise of China’s biotechnology sector.

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FDA Advisory Committee Supports Grail’s Test for Detecting Multiple Cancers

FDA Advisory Committee Supports Grail’s Test for Detecting Multiple Cancers

An independent expert committee voted that the potential benefits of Grail’s Galleri test outweigh its risks, paving the way for an FDA decision while emphasizing that it does not replace recommended cancer screenings.

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Oura Seeks to Raise $2.2 Billion Through IPO Amid Expansion of Smart Rings in Digital Health

Oura Seeks to Raise $2.2 Billion Through IPO Amid Expansion of Smart Rings in Digital Health

Oura filed for an initial public offering that could be worth up to $2.2 billion, offering 50 million shares at an estimated price of between $40 and $44 per share. The offering comes as the company expands its health features, while facing regulatory questions and a proposed lawsuit concerning the accuracy of sleep tracking.

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FDA Funds Test of Using Language Models to Evaluate AI-Generated Radiology Reports

FDA Funds Test of Using Language Models to Evaluate AI-Generated Radiology Reports

The U.S. Food and Drug Administration awarded Cognita Imaging a $1.29 million research contract to test the ability of a group of large language models to evaluate radiology reports produced by artificial intelligence systems. The project aims to measure hallucinations and omissions and identify cases requiring review by a radiologist.

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FDA Advisory Committee to Examine the Use of Pathogen-Agnostic Sequencing in Emergency Response

FDA Advisory Committee to Examine the Use of Pathogen-Agnostic Sequencing in Emergency Response

The U.S. Food and Drug Administration will hold a public meeting on November 19, 2026, to examine the scientific, clinical, and public health dimensions of using sequencing technologies capable of detecting known or unknown pathogens. The meeting will discuss test design and the bioinformatics systems needed to address ongoing changes in genetic sequences.

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New FDA Requirements in eSTAR Move Usability Factors from the Testing Box to the Risk File

New FDA Requirements in eSTAR Move Usability Factors from the Testing Box to the Risk File

The FDA’s 2026 guidance, incorporated into the eSTAR v7.0 form, states that companies are required to demonstrate the acceptability of use-related risks associated with medical devices, not merely submit a human factors testing report. The level of risk and whether use tasks are critical determine the amount of evidence and documentation required in the submission file.

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FDA Explains How Regulatory Authorities Rely on Its Decisions in the Medical Device Field

FDA Explains How Regulatory Authorities Rely on Its Decisions in the Medical Device Field

CDRH has launched a reference portal explaining regulatory reliance programs for assessments and decisions by other regulatory authorities, focusing on using FDA data without transferring decision-making responsibility or reducing safety requirements. The portal provides guidance on verifying the identity of devices and their manufacturing sites and monitoring post-market safety.