Ibex Medical Analytics Ltd. closed a $55 million series C financing round that will allow the company to expand its footprint in the U.S. to meet the increasing demand for artificial intelligence (AI)-powered diagnostic solutions. Ibex has developed the Galen platform which offers AI solutions that allow pathologists to accurately and rapidly detect and diagnose cancer. The company also reported the launch of Galen Breast HER2, a new software which will play a critical role in helping oncologists identify effective therapies for breast cancer patients.
At the same time it reported U.S. FDA clearance for bedside software to diagnose electrographic status epilepticus (ESE) seizures, Ceribell Inc. declared Claritypro the first ICU monitoring device to receive an NTAP reimbursement from the Centers for Medicare and Medicaid Services. The clearance of Claritypro to diagnose ESE follows receipt of an FDA breakthrough device designation in two different categories in the past year, setting the stage, Ceribell CEO Jane Chao told BioWorld, for expanded access to critical seizure diagnosis technology.
Researchers have created an artificial intelligence (AI)-enabled implantable bio-sensing device that can change shape and adapt to maintain drug treatment and bypass scar tissue build up. As the foreign body response continues to impact the longevity of implantable medical devices that treat many conditions, the researchers hope that the Fibrosensing Dynamic Soft Reservoir (FSDSR), capable of monitoring fibrotic capsule formation and overcoming its effects via soft robotic actuations, can change the way patients body respond to therapeutic treatments.
Nevia Bio Ltd. (formerly Gina Life Ltd.) completed a $3.1 million seed round that will allow the company, which has developed a platform that can decode biomarkers data from vaginal secretions for the early detection of ovarian cancer, to conduct clinical trials. With ovarian cancer the leading cause of death in women diagnosed with gynecological cancers, Nevia is hoping that its platform will save many lives.
Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive impairment, as well as the largest company in China in terms of revenue from the commercialization of cognitive impairment DTx products in 2022.
Hypertrophic cardiomyopathy (HCM) might not be the talk of the town in the world of cardiology medical devices, but the condition has a devastating effect on a large number of lives, particularly in the case of early disease onset. San Francisco-based Viz.ai Inc. has won a de novo from the U.S. FDA for its algorithm for identification of patients at risk of HCM, the aptly named Viz HCM, a product the company believes will not only save lives but may save the U.S. health care system a large amount of money as well.
Developers of medical technology have many concerns about the U.S. Centers for Medicare & Medicaid Services’ (CMS) handling of coverage and reimbursement, but those controversies have typically revolved around process. A new report sponsored by industry steers a somewhat different tack, however, arguing that while there are issues of process, one key issue is that of funding, a problem that only Congress can remedy.
Histoindex Pte Ltd.'s’s artificial intelligence (AI)-enabled tissue imaging technology more accurately measures the change in fibrosis than current pathology tests, the company said.
A team from Siemens Medical Solutions Inc. presented a new artificial intelligence (AI) model that can predict people’s risk of multiple sclerosis (MS), at the 2023 American Association for Clinical Chemistry (AACC) annual scientific meeting in Anaheim, Calif.
Premature babies face challenges in the neonatal intensive care unit (NICU) as their heart, lungs and neurological system continue to develop outside the womb. Roughly half of neonates born at 26 weeks to 28 weeks gestation experience respiratory distress. These infants often need extra oxygen and help breathing, as well as constant monitoring to ensure oxygen is absorbed and carbon dioxide (CO2) is dispelled. To that end, Etiometry Inc. received FDA clearance for its IVCO2 Index, a software tool for use in monitoring risk of hypercapnia in NICU patients weighing less than 2 kg.
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