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HUNTLEY, Ill.--(BUSINESS WIRE)--Life Spine, Inc., a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the VersaLift™ Expandable Interbody System, a Micro Invasive™ solution for TLIF and PLIF procedures featuring a low 6mm starting height. Designed to support minimally invasive surgical access, VersaLift offers one of th...

NEW YORK--(BUSINESS WIRE)--Pathway Labs today announced its public launch of EchoNext, the world’s first FDA-approved AI detection tool that reads standard 12-lead electrocardiograms (ECGs) to flag high risk structural heart diseases for patients. Receiving FDA clearance for six indications, Pathway Labs also announced its partnership with OpenEvidence to make EchoNext available on the AI platform regularly used by over half of US clinicians. EchoNext detects heart conditions that clinicians ca...

MIAMI & HOUSTON--(BUSINESS WIRE)--The Society for Neuro-Oncology (SNO), the world's largest multidisciplinary organization dedicated to advancing research, education, and clinical care for patients with brain and spinal cord tumors, and OpenEvidence, the leading AI-powered clinical decision support platform, today announced a landmark partnership, designating OpenEvidence as SNO's official generative AI partner. As part of the collaboration, SNO will embed OpenEvidence across its member-facing...

DENVER--(BUSINESS WIRE)--The FDA has granted premarket approval (PMA) for the HepQuant SHUNT® Liver Diagnostic Test to aid in identifying patients unlikely to require EGD....

ROCHESTER, Minn.--(BUSINESS WIRE)--Dr. Luke Russell appointed president, while CEO Dr. Stephen Russell transitions to chief scientific officer to spearhead scientific strategy....

MINNEAPOLIS--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke, today announced the dosing of the first two patients in an investigator-sponsored Phase 2 trial evaluating DM199 (rinvecalinase alfa) for the treatment of fetal growth restriction (FGR). This is the first clinical evaluation of DM199 in FGR. The open-label, single-arm study is design...

AKRON, Ohio--(BUSINESS WIRE)--BioMendics, LLC, a clinical-stage biotechnology company developing innovative therapies for rare genetic skin disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BM-3103, formulated as TolaSure® Gel™, for the treatment of Epidermolysis Bullosa Simplex (EBS). The milestone comes as the company prepares to attend the BIO International Convention 2026 in San Diego (June 22–25). The designation follows FDA r...

HOUSTON--(BUSINESS WIRE)--For millions of people living with the long-term effects of traumatic brain injury (TBI), the prevailing belief has been that chronic neuroinflammation causes recovery to plateau over time, meaning correspondingly few long-range care options. New research published in the prestigious journal Brain, one of the world’s leading neurology journals, is challenging that assumption. “Our findings suggest that chronic neuroinflammation may be a treatable target, even years aft...

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan-hziy) as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Trodelvy is the first antibody-drug conjugate (...

MINNEAPOLIS--(BUSINESS WIRE)--HistoSonics, l'azienda che ha creato il sistema di istotripsia Edison® e le innovative piattaforma per la terapia con questa tecnica, oggi ha annunciato la chiusura di un nuovo round di finanziamento con la partecipazione di Reed Jobs and Yosemite, il cui obiettivo è “rendere il cancro non-letale nel corso della nostra vita”, assieme a diversi nuovi investitori. Gli ulteriori termini del finanziamento non sono stati divulgati. Il finanziamento giunge in un momento...