FDA appoints first-ever Chief AI Officer; the first at-home HPV test for cervical cancer screening is approved; Assertio to pay $3.6M for illegally marketing fentanyl spray beyond approved use – Morning Medical Update

FDA appoints first-ever chief of AI

The U.S. Food and Drug Administration (FDA) has named Jeremy Walsh as its first Chief Artificial Intelligence (AI) Officer (CAIO?), a newly created role overseeing AI and information technology. Walsh, formerly a chief technologist at Booz Allen Hamilton, brings experience from working with federal health agencies including the FDA and Centers for Disease Control and Prevention (CDC). His appointment comes as the agency faces workforce cuts and aims to streamline operations. Walsh is expected to focus on consolidating data systems and advancing AI policy amid broader government efficiency efforts under the Trump administration.

The first at-home HPV test for cervical cancer screening

More from the FDA — the administration has approved the first at-home human papillomavirus (HPV) test for cervical cancer screening, allowing women to collect vaginal swabs outside a clinical setting using the “Teal Wand.” The test, from Teal Health, aims to boost screening rates by offering a less invasive alternative to in-office Pap smears, which many women avoid. Users will need a telehealth visit to order the test, and samples are mailed to a lab. Experts hope it will improve access — especially in rural areas — but caution that cost, follow-up care and insurance coverage remain key questions. Read more from NBC News.

Assertio to pay $3.6M over marketing of fentanyl spray for unapproved uses

Pharmaceutical company Assertio Therapeutics will pay $3.6 million to resolve allegations it illegally marketed its fentanyl nasal spray Lazanda for patients without breakthrough cancer pain, the drug’s only approved use. The U.S. Department of Justice (DOJ) alleges that between 2013 and 2017, Assertio, known as Depomed at the time, pushed the powerful opioid to high-prescribing doctors, some flagged for drug diversion, and used insurance support programs to boost coverage. The settlement resolves a whistleblower case brought by two former sales reps and comes amid ongoing efforts to hold drugmakers accountable for their role in the opioid crisis.