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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 procedures Mendaera 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 2026 Focalist is designed to support precise & consistent needle placement…
July 9, 2025

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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) tears BEAR 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, 2025

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Boston Scientific’s Farapulse PFA System Receives the US FDA Approval for Pulmonary Vein and Posterior Wall Ablation in Persistent AF Patients

Shots: The US FDA has approved label expansion of Farapulse PFA System to incl. treatment of drug-refractory, symptomatic persistent atrial fibrillation (AF) Approval was backed by P-I data from the ADVANTAGE AF trial, which met safety & effectiveness endpoints in 260 pts intolerant to at least Class I/III anti-arrhythmic drug across 43 global sites; data…
July 8, 2025

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Seegene Introduces STAgora Platform for Real-Time Infectious Disease Analysis

Shots: Seegene has launched the STAgora platform for infectious disease analysis, with a formal launch planned at ADLM 2025to seek business partnerships & highlight STAgora's integration with Cureca PCR system  STAgora, when integrated with Seegene’s syndromic quantitative PCR tech, provides advanced visibility into single & multi-pathogen infections to allow clinicians to make faster, more informed…
July 7, 2025

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Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 30, 2025 – Jul 04, 2025)    

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, and Biosimilar. Check out our full report below:  Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)  Read More: Neurocrine  UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients  Read More: UCB  …
July 4, 2025

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Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

Shots: The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026 Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved…
July 2, 2025

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Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 16, 2025 – Jun 20, 2025)   

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, Animal Health & DigiHealth. Check out our full report below:    Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma  Read More: J&J  Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for…
June 20, 2025

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