Conavi Medical Corp. has announced a peer-reviewed case publication highlighting the use of its hybrid intravascular ultrasound and optical coherence tomography imaging system in a complex coronary intervention involving a patient with impaired renal function. The publication follows U.S. Food and Drug Administration 510(k) clearance for the Canadian medical device developer’s next-generation hybrid IVUS-OCT imaging
UroGen Pharma Ltd. (Nasdaq: URGN) has received U.S. Food and Drug Administration clearance of its Investigational New Drug application for UGN-501, an investigational next-generation oncolytic virus for non-muscle invasive bladder cancer. The clearance enables the urothelial cancer-focused biotechnology company to begin a planned Phase 1 trial of local intravesical administration, with patient enrollment expected to
iHealthScreen Inc. has received U.S. Food and Drug Administration 510(k) clearance for iPredict-DR, an AI-powered Software as a Medical Device for automated diabetic retinopathy screening. The retinal imaging software detects more than mild diabetic retinopathy in adults with diabetes who have not previously been diagnosed with the condition, placing the healthcare AI developer into a
OKYO Pharma’s urcosimod moves toward Phase 3 as the biotech targets neuropathic corneal pain, a severe ocular condition without approved therapy.
Royal Philips’ Alturion ultrasound launch targets AI-powered imaging workflows as hospitals face rising scan volumes and staffing pressure.
Immunome has received U.S. Food and Drug Administration acceptance of its New Drug Application for varegacestat, an investigational once-daily oral gamma secretase inhibitor for adults with desmoid tumors. The application is supported by the Phase 3 RINGSIDE trial and carries an April 28, 2027 target action date, placing the targeted oncology company in a defined
Read how DEA’s proposed Schedule I controls for enhanced 7-OH could reshape kratom products, enforcement and research in the United States.
The LungFX approval gives United Therapeutics control of a centralized donor lung evaluation platform, although clinical warnings, logistics and economics will influence adoption.
Galmed Pharmaceuticals has acquired Colospan and its CG-100 colorectal bypass device, but European adoption, pivotal United States evidence and financing will determine whether the micro-cap company can create a sustainable medtech business.
Find out how Praxis’ FDA Breakthrough Therapy Designation for elsunersen could reshape SCN2A-DEE epilepsy treatment and ASO development.