The U.S. FDA has granted Opticyte Inc. a breakthrough device designation for its Cell O2 patient monitor, a noninvasive technology for monitoring patients at risk of organ failure. The device could help to reduce serious illness and deaths by alerting clinicians to patients experiencing organ failure before irreversible damage occurs.
Nuralogix Corp. is taking its selfie-based health monitoring platform to the next level, offering continuous health and vital signs tracking during video calls. The launch of Anura Telehealth is the newest addition its Anura app, which uses video cameras on smartphones and other consumer devices to extract facial blood flow information and provide a personalized snapshot of health and wellness.
The U.S. FDA has approved Polarean Imaging plc’s drug-device combination product, Xenoview, for use with magnetic resonance imaging (MRI) in evaluating lung ventilation in adults and children aged 12 and older. The hyperpolarized contrast agent, which is prepared from the Xenon Xe 129 gas blend, is expected to be commercially available in the U.S. starting next month.
Movano Inc., dba Movano Health, expects to launch its medical-grade smart ring, Evie, on a one-time cost basis in 2023. The digital wearable, which is designed specifically for women, collects a range of health and wellness metrics, and translates them into personalized, actionable insights for wearers and their doctors.
Women’s health startup May Health SAS has completed treatment of the first five participants in a U.S. feasibility study of its investigational Ovarian Rebalancing technique, a one-time, ultrasound-guided, transvaginal ablation procedure for women with polycystic ovary syndrome (PCOS). The novel treatment is designed to jumpstart the ovaries into releasing mature eggs in normal monthly cycles in women with PCOS-associated infertility.
Fujifilm Corp. inked an agreement to purchase the global digital pathology business of Inspirata Inc., paving the way for expansion of its Synapse enterprise imaging offering. The transaction includes Inspirata’s Dynamyx software, which Fujifilm has distributed in the U.K. and certain European Union countries since mid-2020. Under the agreement, Fujifilm will acquire Inspirata’s digital pathology technology, as well as employees and customers associated with the brand. Financial terms of the deal were not disclosed. It is expected to close in early 2023.
Guardant Health Inc. reported positive results from the ECLIPSE trial demonstrating 83% sensitivity of its DNA blood test in detecting colorectal cancer (CRC) in average-risk adults. Specificity was 90% in people without advanced neoplasia, as well as in those who had a negative colonoscopy result.
Transition ultrasound startup QT Imaging Inc. is poised to go public via a merger with Gigcapital5 Inc., a special purpose acquisition company (SPAC), in a deal that puts the equity value of the combination at $151 million. The combined company, QT Imaging Holdings Inc. will be traded on the NYSE under the ticker symbol QTI.
Apoqlar GmbH received a green light from the FDA for its VSI Holomedicine, a mixed reality software enabling surgeons to plan procedures in an immersive 3D experience. The company expects to release the technology for clinical use in the U.S. in the second quarter of 2023.
Sonothera Inc. reeled in $60.75 million in a series A financing led by Arch Venture Partners. The funds are earmarked for the continued development of Sonothera’s ultrasound-guided, nonviral, gene therapy platform and treatments.
