A new imaging technology that uses transmission ultrasound to provide a 3D image of breast tissue outperformed traditional digital mammography in a recent retrospective analysis. The study findings could set the stage for the U.S. FDA to clear the technology for breast cancer screening in young, high-risk women.
Nextgen Biomed Ltd. has begun a clinical trial of a breath test to monitor antibody levels in individuals vaccinated against COVID-19. Be'er Ya'akov, Israel-based Shamir Medical Center authorized the trial for test developer Scent Medical Technologies Ltd. (Scentech Medical), which is in the midst of merging with Nextgen. The merged company will be called Scentech Medical.
A new $23 million in funds gives Brainbox Solutions Inc. a head start as it begins enrollment in the pivotal clinical trial of its mild traumatic brain injury (TBI) diagnostic and prognostic test. Bioventures Investors took the lead in the series A financing. The Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, and Astia Angels participated in the fundraising round along with qualified investors including the Cleveland Cavaliers' Kevin Love, a mental health advocate.
Emboline Inc., which is developing technology to reduce the chance of stroke during transcatheter heart procedures, completed a $10 million series C financing. The funds are earmarked to gain initial commercial approval of the company’s Emboliner device and to launch a U.S. pivotal study. The round, which included new and existing investors, follows a $5 million bridge round of financing that closed last January.
Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.
While several companies are looking to help recurrent glioblastoma patients, Carthera SAS has taken a step forward by bringing its Sonocloud-9 device into a phase I/II clinical trial. Northwestern University in Chicago will collaborate with the company in the trial, which is expected to enroll up to 39 patients. The first patient already has been treated.
Edwards Lifesciences Corp. launched a pivotal trial of its mitral valve repair system in the U.S., with the first patient undergoing treatment for severe degenerative mitral valve regurgitation at the University of Maryland Medical Center in Baltimore. Open-heart surgery is the current standard approach to mitral valve repair, but the Harpoon Beating Heart mitral valve repair system allows surgeons to use a minimally invasive approach, according to Edwards Lifesciences.
Researchers at Thomas Jefferson University have found that using ultrasound to pop microbubbles already present in a contrast agent nearly doubled liver tumor response to transarterial radioembolization. The procedure raised no safety concerns and increased the likelihood of patients receiving a liver transplant.
Eyenovia Inc., a clinical-stage ophthalmic biopharmaceutical firm, has launched a phase III trial of its on-demand treatment for presbyopia, an age-related worsening in near vision. The treatment, called Microline, is a proprietary formulation of pilocarpine delivered via a microdosing dispenser.
Clinics, urgent care centers, busy hospitals, and patients can count on Hemoscreen, a miniaturized point-of-care hematology analyzer made by Pixcell Medical Technologies Ltd., to provide accurate complete blood count (CBC) results, according to a study published in the Journal of Applied Laboratory Medicine. The study found the small unit better differentiates between cells and adapts to inference than conventional laboratory blood analysis.