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*August 2024 MedTech News Roundup* ◼ Regulatory Approvals Centerline Biomedical: Secured FDA clearance for the Viewpoint Catheter. Diality: Granted FDA clearance for its smart dialysis system. AventaMed: Awarded FDA 510(k) clearance for an all-in-one ear tube placement system. Neuros Medical, Inc. Medical: Received FDA approval for its Altius direct electrical nerve stimulation system. CereVasc: Awarded FDA breakthrough device designation for its eShunt system. Jupiter Endovascular: Got FDA approval for the Vertex Pulmonary Embolectomy System's U.S. pivotal study. Renata Medical: Approved by the FDA for the Minima growth stent tailored for neonates. Accuray: Received CE mark approval for its Helix CT-guided radiotherapy system. Boston Scientific: Achieved CE mark approval for the Acurate Prime Aortic Valve System. OBVIUS Robotics, Inc. Robotics: Granted FDA breakthrough device designation for the CERTA Access platform. Colospan Ltd.: Received FDA BDD for its intraluminal bypass device. THINK Surgical: Granted 510(k) clearance for its TMINI miniature robotic system. Clearmind Biomedical: Received FDA 510(k) clearance for its Neuroblade neuroendoscopy device. ◼ Funding News LN Robotics: Secured Series B funding. Noze: Received $5 million from the Bill & Melinda Gates Foundation NanoHive Medical: Raised $7 million Series C for 3D-printed spinal interbody fusion devices. Caresyntax: Announced a $180 million raise for scaling its surgical software offerings. HistoSonics, Inc.: Closed a $102 million Series D for its targeted liver tumor treatment device. Backpack Healthcare: Awarded a $1.1 million grant for family mental health initiatives. CairnSurgical, Inc.: Secured a $4.5 million raise for image-guided surgical tools. Moximed: Closed a $91 million Series D for its knee system and implantable device. XII Medical: Raised $45 million Series B. Melodi Health: Completed a $10.75 million oversubscribed Series A and launched a clinical trial. ◼ M&A Stryker: Acquired care.ai and Vertos Medical. Johnson & Johnson MedTech: Added V-Wave to its list of acquisitions. Edwards Lifesciences: Acquired JC Medical, Inc. Novartis: Received a binding offer from Siemens Healthineers for its molecular imaging business for approximately $224 million. PaceMate® : Acquired the Paceart Optima cardiac workflow solution from Medtronic. ◼ Technology and Other Developments KARL STORZ and FUJIFILM Holdings America Corporation: Partnered on next-gen endoscopy tech. Dexcom: Launched Stelo over-the-counter CGM. Arsenal Medical: Announced positive results from their first in human trial. BURL Concepts: Entered a strategic partnership with Bracco Imaging. Medical Microinstruments, Inc.: Completed a preclinical study for their neurosurgical robotic system. Noctrix Health, Inc. Health: Announced new CMS reimbursement codes and payment for TOMAC Therapy for Restless Legs Syndrome (RLS). #medtech #innovaton #medicaldevice