Fifty percent of infertility cases arise from issues with the male partner, but standard protocols often delay the first assessment of males for at least two years. Posterity Health Inc. aims to usher in a new generation of fertility care starting with its just-closed $13 million series A financing round.
Nearly six weeks after Johnson & Johnson paused the U.S. external evaluation of its Varipulse pulsed field ablation catheter to investigate several neurovascular events in initial cases, the med-tech giant resumed its limited market release with revised global instructions for use.
With rates of preeclampsia skyrocketing, the U.S. FDA’s510(k) clearance of Roche Holding AG’s Elecsys test for preeclampsia offers some hope of reducing the number of women and infants who die or experience life-long consequences from the development of dangerously high blood pressure during late pregnancy and in the days immediately following delivery.
Ziwig SAS, which leads the race for a simple diagnostic for endometriosis, picked up the pace with a fast-track reimbursement decision in France for its Endotest, the first saliva-based diagnostic assay for endometriosis.
Edwards Lifesciences Corp.’s posted fourth quarter results slightly ahead of expectations, but indicated that the first quarter of 2025 might not be as bright. The company expects growth for both its lead transcatheter aortic valve replacement (TAVR) business and the company to fall below its full-year estimates, with a mid-year indication expansion for TAVR providing a critical boost in the back half of 2025.
Be (not too) still my heart: Kestra Medical Technologies Ltd., maker of a wearable cardioverter defibrillator for patients at high risk of cardiac arrest, filed an S-1 with the U.S. SEC on Feb. 9 to raise $100 million in an IPO. Kestra will be the fourth med-tech company to file for an IPO in 2025, setting a pace well ahead of the last three years. U.s.car
A 1,000-person study using Heartflow Inc. technology demonstrated that findings of coronary plaque on heart CT scans could indicate which patients were at risk of cardiovascular events up to seven years in the future – potentially providing a road map toward screening for heart disease, the leading cause of death for both men and women in the U.S. and worldwide.
The Comma Collective Inc. raised $2 million in a seed round to support the launch of its secure period tracker and disease detection app, Sara, and further development of its products.
In keeping with the trend in med tech to return to basics, Becton, Dickinson and Co. plans to split off its biosciences and diagnostic solutions unit to create two pure-play companies. The ‘New BD’ or RemainCo. will be a focused medical technology company that will include the current company’s medication delivery, specimen management, patient monitoring, pharmaceutical systems, urology, critical care, peripheral intervention and surgery businesses.
Curently the only available blood test to tell which women are at risk of postpartum depression (PPD) is the one that confirms their pregnancy – and a one in seven chance of developing the condition which can have long-term implications for both mother and child. Research out of the University of Virginia and Weill Cornell Medicine could soon change that by identifying biomarkers in the third trimester of pregnancy that indicate which women have the greatest risk of developing PPD.
