Press Releases

As part of its continued efforts to diversify and bring optionality to providers, BioLab Holdings, Inc., a Phoenix-based medical technology company focused on advancing tissue restoration, announced a strategic partnership with mimiX AWC, a regenerative medicine company developing autologous wound care technologies designed to harness the body's own biology to support healing. Through the partnership, BioLab will add FastSkin® Patch, a Whole Blood Clot Technology, to its portfolio of

Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient-monitoring solutions, today announced CE Mark for smartSedLine™, its next-generation brain function monitor featuring an AI-powered Patient State Index (PSi) algorithm designed to deliver an index that is more responsive to underlying brain activity and provides increased stability during anesthesia. This milestone is another example of how Masimo and Danaher are accelerating id

Diabetes technology has advanced significantly, but it can still place a heavy burden on people who rely on it every day — from thinking about where and how to wear devices to balancing diabetes management with the life they want to live. With Instinct now available with MiniMed Flex™, people have more choice in how they manage their diabetes. The combination of discreet,1* longer-wear technology1 and proven automation is designed to reduce the work and interruptions of diabetes m

Neuralytix, LLC (www.nerve.health) today announced full commercial availability of its iD3 System, an FDA 510(k)-cleared mechanomyography (MMG) platform that gives spine surgeons real-time, objective feedback on neurophysiologic changes occurring throughout decompression surgery. The launch builds on the system's initial commercial release in October 2025 and is now available through Neuralytix' U.S. distributor network. The iD3 System is surgeon-directed and requires no ded

Neuralytix, LLC (www.nerve.health) today announced full commercial availability of its iD3 System, an FDA 510(k)-cleared mechanomyography (MMG) platform that gives spine surgeons real-time, objective feedback on neurophysiologic changes occurring throughout decompression surgery. The launch builds on the system's initial commercial release in October 2025 and is now available through Neuralytix' U.S. distributor network. The iD3 System is surgeon-directed and requires no ded

Onkos Surgical, a leader in innovative solutions for musculoskeletal oncology and complex orthopaedic conditions, today announced the completion of the 1,000th case utilizing its personalized, 510(k) cleared, My3D® patient-specific pelvic implant platform. The milestone reflects the impact of innovative 3D printing technology and personalized approaches to orthopaedic cases where anatomy, bone loss, tumor involvement, and revision history benefit from an individualized approach.

CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell” or the “Company”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for two new AI algorithm enhancements integrated directly into its existing cloud-based Neurology Portal: Epileptiform Abnormality Detection and Artifact Reduction.1 These new capabilities expand the clinica

Kardium Inc., a private medical device company that’s advancing the way the world treats atrial fibrillation (AF), announced today that Health Canada has granted a Medical Device Licence for the Globe® Pulsed Field System. Building on the successful U.S. launch of the Globe System following FDA approval in 2025, Health Canada approval marks the next major milestone in expanding access to Kardium’s integrated mapping and pulsed field ablation platform. Developed in Ca

Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative interventional technologies intended to transform eye care and improve patients' lives, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the OMNI® Ultra Surgical System (OMNI Ultra) for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG).

 SOPHiA GENETICS (NASDAQ: SOPH) today announced a new global collaboration to develop, validate, and deploy two companion diagnostics (CDx) supporting precision oncology therapies with AstraZeneca (LSE/STO/NYSE: AZN). This multi-year collaboration agreement will advance the development and commercialization of two companion diagnostic programs, bringing SOPHiA GENETICS's decentralized clinical trial assays and companion diagnostic capabilities to AstraZeneca therapies.