The US Food and Drug Administration (FDA) has finalized a revised draft guidance from 2022 on what Human Factors (HF) information Sponsors should include in Premarket submissions for medical devices.
The first panic attack Quinn Pulsipher remembers having was at 8 years old. They describe it as “a pitch-black ghost that hugs them all over and tries to control their mind.” At the beach on vacation with their family, the wind suddenly picked up, and Quinn began hyperventilating, screaming, and crying uncontrollably. Nothing could calm them down.
“Beauty is pain,” goes a famous maxim. Physiologically, there is some truth to it; studies have shown that chronic pain does last longer and feel stronger for women than men, despite such claims often being dismissed. New research published in Feruary 2026 in Science Immunology might finally suggest why.
Mouse research points to new infertility treatment using approved drug: Research with mice showed that the FDA-approved drug finerenone can stimulate early follicle growth, leading to more mature eggs and increased fertility. In a small, uncontrolled study with people who have primary ovarian insufficiency, treatment with finerenone was followed by the production of mature eggs and fertilized embryos, suggesting a possible new option for patients who typically cannot benefit from standard IVF.
The European Commission in the beginning of May 2026 published an implementing regulation that outlines uniform quality management and procedural requirements for conformity assessment activities conducted by notified bodies under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
In the latest update to COVID and vaccine-related discourse bubbling up at the FDA, Agency officials have recently blocked the publication of several safety studies conducted on COVID and shingles vaccines, The New York Times reported in mid-May 2026.
Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year (in 2026) unveiled, for the first time, draft Guidance on best practices for the industry when replying to the receipt of a Form FDA-483, Inspectional Observations.
U.S. Food and Drug Administration (FDA) Commissioner Marty Makary said the Agency should apply the same urgency as it did to approve the first treatments for HIV/AIDS in the 1990s to new drugs and medical devices, including those for Alzheimer’s disease, Type 1 diabetes, and cancer.
Changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are in the pipeline; however, a speaker at a recent meeting (in Columbus, Ohio) told attendees not to change their priorities based on proposed legislation.
The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions planned for the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to ease post-market surveillance requirements may compromise patient safety.