News
Tandem secures FDA approval for Control-IQ+ use in pregnancy
2+ hour, 36+ min ago (319+ words) The approval is based on findings from the CIRCUIT trial published in JAMA in October 2025. Tandem Diabetes Care has received approval from the US Food and Drug Administration (FDA) for its Control-IQ+ automated insulin delivery technology to be used during…...
FDA clears Sibel Health's ANNE Maternal wireless system
2+ week, 4+ day ago (325+ words) ANNE Maternal is a sister platform to ANNE One, which has also been cleared by the FDA for adolescent and adult monitoring. Sibel Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for ANNE Maternal, a wireless…...
May Health gains CE mark for infertility treatment
4+ mon, 1+ week ago (308+ words) The Anavi system treats polycystic ovary syndrome by delivering targeted radiofrequency energy to ablate ovarian tissue to re-initiate ovulatory cycles. France-headquartered May Health has secured a European CE mark for its Anavi system to address infertility in women with polycystic…...
China NMPA approves Bracco Imaging's contrast agent for infertility diagnosis
8+ mon, 3+ week ago (359+ words) The diagnostic performance of Hy Co Sy with SF6 microbubbles claims to have been validated by a meta-analysis of 24 trials. China's National Medical Products Administration (NMPA) has approved Bracco Imaging's ultrasound contrast agent, sulphur hexafluoride (SF6) microbubbles, for use in a contrast-enhanced…...
AI-automated IVF procedures represent a new era in fertility treatment
11+ mon, 3+ week ago (472+ words) A baby has been born following an AI-automated in vitro fertilisation (IVF) procedure conducted remotely by engineers and fertility specialists. The embryo was made using a method called intracytoplasmic sperm injection (ICSI), a type of IVF that has been around…...