Detect-ION, a diagnostics-focused startup based in Tampa, Florida, has announced a collaborative project with the Infectious Diseases Division at Mayo Clinic Florida to develop a non-invasive breath test for detecting Pseudomonas aeruginosa, a leading cause of pneumonia in vulnerable patient populations. Funded through the Mayo Clinic Advanced Innovation Research program, the project aims to address […]
Bioretec Ltd, the Finland-based medical device developer specializing in fully biodegradable orthopedic implants, has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its RemeOs DrillPin. The designation applies to the use of the biodegradable magnesium-alloy device in pediatric and adult bone fixation procedures, including epimetaphyseal fractures in children over two years […]
Ivonescimab shows 80 percent response in TNBC Phase II study. Explore how Akeso’s bispecific strategy could reshape PD-1 therapy in first-line settings.
Roivios Ltd., a clinical-stage medical device developer focused on kidney health, has reported promising results from its first-in-human trial of the JuxtaFlow Renal Assist Device. This investigational system applies controlled negative pressure to the renal pelvis to enhance urine output and sodium excretion in patients with diuretic-resistant cardiorenal syndrome and acute decompensated heart failure. While […]
Bendit Technologies has secured 510(k) clearance from the U.S. Food and Drug Administration for its Bendit17 steerable microcatheter, a device the company describes as the smallest steerable microcatheter available for use in neurovascular and peripheral endovascular interventions. With U.S. commercialization slated to begin in January 2026, the Israel-based medical device manufacturer is also pursuing regulatory […]
Fondazione Telethon has received regulatory approval from the United States Food and Drug Administration for Waskyra (etuvetidigene autotemcel), an ex vivo gene therapy designed to treat Wiskott-Aldrich syndrome, a rare X-linked primary immunodeficiency. This approval makes Waskyra the first gene therapy for this condition cleared for use in the United States and solidifies Fondazione Telethon’s […]
Exact Sciences Corporation has presented first-time clinical results for its Oncodetect molecular residual disease (MRD) test in early triple-negative breast cancer (TNBC), showcasing a strong correlation between circulating tumor DNA (ctDNA) detection and recurrence risk following neoadjuvant therapy and surgery. The results, drawn from a 147-patient cohort in the NSABP B-59 substudy, were unveiled at […]
Bantam Pharmaceutical has treated the first patient with BTM-3566 in a Phase 1 clinical trial at the Princess Margaret Cancer Centre in Toronto. The study marks the first-in-human administration of the company’s lead investigational therapy, a first-in-class small molecule designed to treat aggressive cancers by modulating the OMA1-ATF4 integrated stress response pathway. This trial includes […]
ImmunityBio Inc. has received a positive recommendation from the European Medicines Agency for conditional marketing authorization of its immunotherapy ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin for the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The recommendation positions ANKTIVA as the first immunotherapy in the European Union for this indication, […]
Gad Medical Ltd. has received regulatory clearance in Israel to commence commercial distribution of the RJB intraoperative angle measurement system from Ruthless Spine, a United States-based medical technology company. This milestone follows the companies’ earlier distribution agreement and paves the way for hospitals and surgical centers across Israel to integrate the RJB platform into thoracolumbar […]