Israeli startup Sanolla Ltd. won U.S. FDA 510(k) clearance for its smart-infrasound stethoscope Voqx. The artificial intelligence (AI)-based device is the first stethoscope cleared by the U.S. FDA to detect infrasound and audible information to identify clinical conditions. The auscultation capabilities are designed to support early assessment of cardiopulmonary conditions. Read More
Merit Medical Systems Inc. received FDA 510(k) clearance for the Scout Bx delivery system, which enables the placement during stereotactic and MRI-guided biopsy of a reflector to guide breast surgery. The delivery system works with the company’s Scout reflector, a wire-free radar localization device. Read More
Ossio Inc. has received FDA clearance for Ossiofiber suture anchors used to fix soft tissue to bone in the shoulder, foot and ankle. This is the most recent of clearances for the company’s intelligent bone regeneration technology which began in 2019 as a possible alternative to permanent fixation implants for the foot and ankle alone. Read More
Meduni Vienna, the Medical University of Vienna, Austria, is working on a novel eye scanner combining the structural and functional sensitivity of optical coherence tomography (OCT) with the chemical specificity of Raman spectroscopy, to acquire data from the living human eye. Read More
The National Health Research Institutes (NHRI) of Taiwan has teamed up with Taiwanese computer manufacturer Asustek Computer Inc. and American cloud computing company Nvidia Corp. to build Taiwan’s first supercomputer for medical research. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abingworth, Carlyle, Crosscope, Davita, Newstem, Rockwell Medical, Royal Philips, Stryker. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Merit Medical, Sanolla, Truvic. Read More
