On March 31, 2025, the Eastern District of Texas issued a decision in the case brought by the American Clinical Laboratory Association (ACLA) and ...

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...

The US Food and Drug Administration (FDA) has granted approval for Innoblative Designs' investigational device exemption (IDE ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs have had ...

who claims Americans’ food is packed with unsafe ingredients and chemicals—will not affect drug, medical device, or food reviewers or inspectors, HHS said. HHS said the cuts will likely be ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s ...

For the FDA, the workforce reduction “will not affect drug, medical device or food reviewers, nor will it impact inspectors,” as the food and drug agency will “focus on streamlining ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. A disease detection chatbot ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Sarah Todd returned to ...

Eva Temkin, a lawyer at Arnold & Porter who advises clients on drug and medical device applications, said even if product reviewers are not terminated in the next round of layoffs, other FDA staff ...