Royal Philips NV received a second round of funding from the Bill & Melinda Gates Foundation to speed adoption of artificial intelligence (AI) algorithms on the Lumify hand-held ultrasound device, bringing its total commitment to the project designed to reduce maternal mortality to $60 million.
The U.S. FDA granted clearance to two tests developed by Thermo Fisher Scientific Inc. to predict preeclampsia, Brahms PIGF plus Kryptor and Brahms sFlt-1 Kryptor. Both had previously received breakthrough designation. Preeclampsia, a hypertensive disorder, is the leading cause of maternal and fetal mortality and morbidity across the globe.
By analyzing gene expression patterns in the placenta of nearly 150 pregnancies and comparing them to fetal gene expression in the brain, researchers from the Lieber Institute for Brain Development have gained new insights into the importance of placental tissue in setting the risk trajectory for the development of schizophrenia. The work was published in Nature Communications on May 15, 2023.
Noting that the FDA had rejected its previous proposal last year to voluntarily withdraw Makena from the U.S. market, Covis Pharma BV is again offering to voluntarily withdraw the drug, which is the only drug approved to reduce the risk of preterm birth. Along with its offer, the company asked the agency “to allow for an orderly wind-down that would best serve the interests of the patients,” according to a March 6 letter from Covis’ attorney to FDA Commissioner Robert Califf and Namandjé Bumpus, the agency’s chief scientist.
Citing federal preemption, the U.S. Court of Appeals for the First Circuit tossed multidistrict litigation (MDL) involving GSK plc’s labeling of Zofran, an antiemetic approved for postoperative use and in conjunction with chemo or radiation, but that is commonly used off-label in pregnancy.
The first home pregnancy test to analyze saliva rather than urine is due to be on the shelves in Europe at the start of 2023, following CE approval of Salistick, developed by saliva diagnostic specialist Salignostics Ltd.
For the one in eight couples struggling to conceive, the improvements in infertility treatments achieved by employment of artificial intelligence (AI) in diagnostics, personalized therapies and embryo selection may soon mean the difference between childlessness and the family of their dreams.
The U.K.’s National Institute for Health and Care Excellence (NICE) has added two placental growth factor (PIGF)-based tests developed by Perkinelmer Inc. to guidance on diagnosing suspected preterm preeclampsia. The Waltham, Mass.-based company’s kit and Delfia Xpress soluble fms-like tyrosine kinase 1 (sFlt-1) kit are recommended to screen levels of PIGF and Sflt-1, both key biomarkers in the pathophysiology of preeclampsia. The guidance means health care providers across the U.K. will be able to use the test, along with a standard clinical assessment, to confirm suspected preterm preeclampsia in women from 20 weeks of pregnancy onwards.
A study published in Human Reproduction showed no developmental delays in children conceived using capacitation-in vitro maturation (CAPA-IVM) technique developed by Lavima Fertility Inc. compared to those born through conventional in vitro fertilization (IVF). Researchers presented the results at a July 6 session of the European Society of Human Reproduction and Embryology in Milan, Italy.
LONDON – The U.K. has set up the first randomized controlled trial of COVID-19 vaccines in pregnant women, to assess different dosing schedules. The aim is to find the balance between longer intervals that are known to spur a greater immune response, against shorter intervals that provide faster protection.