Vesalio has received 510(k) clearance from the U.S. Food and Drug Administration for enVast, its stent-based coronary clot retrieval system, making it the first device of its kind approved for mechanical thrombectomy in the cardiac circulation. The approval authorizes enVast for U.S. commercialization, following prior regulatory clearance and use in European markets. The device is
Xtant Medical Holdings, Inc. has launched its next-generation synthetic bone graft, nanOss Strata, in the United States. The graft, built from hydroxycarbonapatite (HCA), is designed to enhance bioactivity and integration in orthopedic and spinal surgeries. This launch follows the company’s strategic exit from non-core spinal implant assets, signaling a renewed focus on its biologics portfolio.
Geneva Private Equity has launched NXXIM, a new AI-powered enterprise medical imaging platform designed to unify radiology, pathology, genomics, and electronic health record data into a single, real-time diagnostic environment. The investment-backed venture will pilot its platform in clinical settings in 2026, aiming to streamline fragmented workflows and reduce time-to-diagnosis for large health systems. What
Illumina, Inc. and MyOme, Inc. have announced a new strategic collaboration, including an equity investment by Illumina to support MyOme’s upcoming Proactive Health (MPH) Trial. The large-scale clinical study, expected to begin in 2026, will evaluate the impact of artificial intelligence-integrated whole-genome sequencing on chronic disease prevention and cost savings across the U.S. healthcare system.
Pillar Biosciences has expanded its collaboration with AstraZeneca to bring its next-generation sequencing-based liquid biopsy kits to China, aiming to accelerate localized tumor profiling and broaden access to precision oncology diagnostics. The partnership, which includes Shanghai Zhengu Biological Technology Co., Ltd., is designed to support assay implementation across Chinese hospital laboratories to reduce diagnostic turnaround
InstaMed Pharmaceuticals has reported rapid commercial traction for its InstaRelease oral dissolving strip, a patented non-injectable peptide delivery technology. The company announced a 300 percent month-over-month sales increase since its May 2025 launch and shared results from a double-blind pharmacokinetic study validating buccal absorption of glutathione as an effective alternative to traditional injection. The platform
Peijia Medical has received regulatory approval from the National Medical Products Administration of China for the TaurusTrio Transcatheter Aortic Valve system, a dedicated device for the treatment of native symptomatic severe aortic regurgitation. Developed under an exclusive license from JenaValve Technology, the system is based on the latter’s Trilogy Transcatheter Heart Valve platform and represents
Roivios Ltd., a clinical-stage medical device developer, has announced encouraging results from its first-in-human study of the JuxtaFlow Renal Assist Device, a technology designed to support fluid removal and renal function in patients with diuretic-resistant cardiorenal syndrome and acute decompensated heart failure. The results, published in the ASAIO Journal, showed that JuxtaFlow significantly improved both
KVP International has announced the acquisition of SafePath Laboratories and IVD Research, a diagnostics manufacturer and contract development and manufacturing organization (CDMO) provider headquartered in Carlsbad, California. With this move, KVP International aims to strengthen its footprint in veterinary diagnostics while unlocking the potential to expand into human health markets. This acquisition provides KVP International
Sanyou Biopharmaceuticals (Shanghai) Co., Ltd. and Wenzhou KanryBio Biotechnology Co., Ltd. have entered into a strategic collaboration focused on co-developing high-value reagents and products for biomarker assay kits. Announced on December 10, 2025, this partnership aims to combine Sanyou Biopharmaceuticals’ global leadership in AI-driven molecular discovery with KanryBio Biotechnology’s capabilities in kit product development and