It’s not unusual for women to have some uterine contractions during pregnancy. Many of these go unnoticed, but others can be strong and feel like labor. Distinguishing between normal contractions and those that are not can help ensure women at risk of preterm labor get the extra medical care they need. To that end, Tel Aviv-based Nuvo Group Ltd. has launched an FDA-cleared uterine activity (UA) module on its Invu remote monitoring platform.
Renovia Inc. closed a $17 million C-1 equity funding round led by new investor Parian Global Management. Perceptive Life Sciences, Longwood Fund, Ascension Ventures and OSF Ventures added to their existing investments in the company, which develops prescription digital therapeutics for female pelvic floor disorders.
Merck & Co. Inc. telegraphed the future focus of Organon & Co., which will spin off from the pharmaceutical giant as a public company in the first half of 2021, with an announcement of an agreement to acquire Alydia Health Inc. Alydia makes the Jada system, which treats postpartum hemorrhage.
The COVID-19 pandemic has thrown a wrench in routine medical exams, scaring many patients away from in-clinic visits and diverting resources to coronavirus-related needs. For pregnant women, who require frequent checkups but don’t want to risk infection, this can be a particularly trying time. Now, Israeli startup Pulsenmore Ltd. has launched a hand-held device that lets women perform ultrasounds in their own home and relays the results to a doctor or sonographer for evaluation and feedback.
Uncontrolled bleeding after giving birth is a common cause of severe maternal complications and even death, particularly in the U.S. and some developing nations. Alydia Health Inc. has developed a suction device that is placed in the uterus and is designed to halt hemorrhaging within a few minutes.
LONDON – An independent U.K. inquiry has found that failure to take seriously concerns raised by patients has resulted in life-threatening problems caused by medical devices and drugs being ignored for decades.
HONG KONG – Singapore-based Igene Laboratory, a wholly owned subsidiary of Inex Innovate Pte. Ltd., has launched a noninvasive prenatal test (NIPT) that assesses fetal Rhesus factor (RhD) status from a maternal blood sample.
A wireless system to monitor mothers in labor and their fetuses has been introduced by Royal Philips NV in the U.S. Known as the Avalon CL Fetal and Maternal Pod and Patch, it is commercialized under recently updated guidance from the U.S. FDA. The Amsterdam-based company is continuing to pursue a standard 510(k) clearance for the system, which is marketed in European countries, Australia, New Zealand and Singapore.
Alydia Health Inc., of Menlo Park, Calif., has completed enrollment in the pivotal PEARLE investigational device exemption (IDE) study, which is assessing the safety and effectiveness of the Jada system to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage.
Researchers are hopeful that within three to five years the first once-a-month oral contraceptive could reach human testing. They achieved an early step on that path with the publication of research testing the long-lasting drug delivery device from Watertown, Mass.-based startup Lyndra Therapeutics Inc. in the Dec. 4 issue of Science Translational Medicine.