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Mendaera’s Focalist Robotic System Secures the US FDA 510(k) Clearance for Ultrasound-Guided Procedures

Shots:Mendaera has received the US FDA’s 510(k) clearance for Focalist robotic system for ultrasound-guided proceduresMendaera will begin a limited launch of its Focalist system in 2025 to initially support urology procedures like PCNL, expanding to other specialties, with full commercialization expected in 2026Focalist is designed to support precise & consistent needle placement…
July 9, 20250Comments

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Lupin Joins Forces with Zentiva to Develop TNF-Alpha Inhibitor Biosimilar

Shots:Zentiva has entered into a license & supply agreement with Lupin to commercialize Lupin's TNF-alpha inhibitor biosimilar across multiple global marketsZentiva will lead commercialization outside the US & Canada, mainly in EU & CIS, while Lupin will handle development, manufacturing, & supply in agreed territories & commercialization in the remaining territories, incl. the…
July 9, 20250Comments

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HealthBook+ Launches PaiGE for Real-Time Personalized Health Insights

Shots:HealthBook+ has launched PaiGE, a personal health assistant that provides real-time, personalized health insights for both pts & cliniciansPaiGE offers consumers personalized lifestyle recommendations, shareable health records, mood & lifestyle-based insights, & a secure way to seek health information, while also guiding them to track progress between visits with clinician-backed instructions & PaiGE's…
July 9, 20250Comments

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INSIGHTS+

Key Biosimilars Events of June 2025  

Shots:       Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06. Our…
July 8, 20250Comments

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Miach Orthopaedics Completes Patient Enrollment in BEAR MOON study of BEAR Implant for ACL Reconstruction

Shots:Miach Orthopaedics has completed enrollment in the BEAR MOON study of BEAR Implant for the treatment of anterior cruciate ligament (ACL) tearsBEAR MOON trial, led by Cleveland Clinic, enrolled 150 pts (18–55yrs.) with complete ACL tears, randomized to receive either the BEAR Implant or autograft bone-patellar tendon-bone ACL reconstruction, with outcomes assessed at 6mos.,…
July 8, 20250Comments

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