Earflo wins FDA nod for pediatric ear pressure treatment device
April 29, 2026
Earflo announced that it received FDA clearance for its non-invasive device designed to treat negative middle ear pressure in children.
Earflo announced that it received FDA clearance for its non-invasive device designed to treat negative middle ear pressure in children.
LAGUNA HILLS, Calif., April 29, 2026 /PRNewswire/ — Prelude Corporation (PreludeDx™), a leader in precision diagnostics for early-stage breast cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the AidaBREAST® test.
Tandem Diabetes Care (Nasdaq:TNDM) today announced FDA clearance for its automated insulin delivery (AID) technology for use in pregnancy.
The ArteraAI prostate biopsy assay predicts the risk of prostate cancer progression.
AI will soon enable clinicians to predict ovulation and optimize IVF cycle timing, improving outcomes and operational efficiency.
Scientists have found new genetic causes for diabetes in babies—in a part of the genome that has historically been overlooked in genetic studies.
Sibel Health today announced FDA 510(k) clearance of ANNE® Maternal, the world’s first fully wireless, comprehensive maternal-fetal monitoring platform.
PITTSBURGH, April 8, 2026 /PRNewswire/ — “Our intention is to create a more accurate and exact wearable device to determine the onset of the female ovulation cycle and consequently when a female human or animal is most likely to become pregnant after insemination,” stated one of the two inventors, from Gainesville, Virginia, “hence the invention of the Ovulonics device. Our design would provide an easy, convenient and accurate detection time for human or animal
Sabrina Martucci Johnson wants everyone to invest in her women’s health biotech Daré Bioscience. That means you, dear reader.
MILFORD, Mass., April 8, 2026 /PRNewswire/ — Waters Corporation (NYSE: WAT) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening, and removing barriers that currently prevent many individuals from receiving routine screening.