Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software.
Classified as a class II medical device, MediAI-BA evaluates bone age and suggests predicted adult height based on growth plate status assessed by hand and wrist X-ray imaging. Prior clinical trial results demonstrated MediAI-BA had specialist-level accuracy, recording a mean absolute deviation (MAD) of 0.39 years.
After being unanimously passed by the U.S. House Dec. 1, the bipartisan Mikaela Naylon Give Kids a Chance Act seemed to be headed for sure passage in the Senate before it adjourned late last week.
Bronchopulmonary dysplasia (BPD) remains a significant challenge in neonatal care, particularly affecting preterm infants with low birth weight who often require oxygen therapy or mechanical ventilation to survive.
Medline Inc. filed a public S1 with the SEC Oct. 28, moving the IPO first signaled in December 2024 closer to reality. The Northfield, Ill.-based medical supply distributor did not disclose the number of shares to be offered or their price, but Renaissance Capital expects the IPO to raise about $5 billion, which would make it the largest in any industry this year and one of the largest ever in med tech. Billiontoone Inc. also advanced its IPO, as it began the road show for its public debut in early November.
Genedx LLC partnered with Illumina Inc. to test whether Illumina's constellation map read technology could shed light on hard-to-detect variants that appear in rare diseases. Constellation met or exceeded the ability of other sequencing methods to detect variants implicated in multiple disorders and worked across a range of sample types, a study presented at the American Society for Human Genetics (ASHG) Annual Meeting in Boston on Oct. 15 found.
Up to 71% of people carry at least one pathogenic variant that could contribute to development of a heritable disorder in offspring, but until now, prospective parents often had to undergo multiple tests to understand their risks. Pacific Biosciences of California Inc. (Pacbio)’s expanded Puretarget portfolio provides a quicker and more streamlined solution as it covers all challenging tier 3 genes identified in the American College of Medical Genetics technical standard.
Researchers from the University of California, Davis (UC-Davis) continue to assemble intellectual property in support of their development of methods and techniques which improve the accuracy of wearable sensor technologies.
For more than 30 years, the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) worked together to harmonize their evidence-based vaccine schedules. Not anymore.
Collaborators in Australia, South Africa, Sweden and the U.K. have linked reduced levels of neuronal cell adhesion molecule (NrCAM) in maternal or placental blood to greater risk of fetal growth restriction
in newborns and of preeclampsia in the mothers, based on analysis of various cohorts of patients from several countries.
Cochlear Ltd. heard good news from the U.S. FDA, as the agency approved its next-generation cochlear implant, the Nucleus Nexa System, the first smart cochlear implant system. Cochlear expects to launch the new products in the U.S. in the next few months, Brendan Murray, vice president for Cochlear Implant products portfolio and strategy told BioWorld.
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