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Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 14, 2025 – Jul 18, 2025)   

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth and Biosimilars. Check out our full report below:Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)Read More: TakedaAstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant…
23 hours ago

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RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software

Shots:Accuro 3S ultrasound system & SpineNav-AI received FDA clearance to provide anatomical guidance during needle or catheter placement; further regulatory filings for advanced features are planned, alongside ongoing clinical collaborations, limited release, & upcoming full market launchAccuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer…
2 days ago

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Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 07, 2025 – Jul 11, 2025)   

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, and Biosimilars. Check out our full report below:  PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy  Read More: PulseSight Therapeutics BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with…
July 11, 2025

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Exactech Reports the US FDA 510(k) Clearance of Equinoxe Scapula Reconstruction System for Acromial Stress Fractures

Shots:Exactech has received the US FDA 510(k) clearance for the Equinoxe Scapula Reconstruction System to treat acromial & scapular spine fractures; limited US pilot launch is expected later this yearEquinoxe Scapula Reconstruction System allows orthopedic surgeons to treat scapular fractures using single & dual plating techniques, which is compatible with any rTSA implant…
July 10, 2025

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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, 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) 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, 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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