Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

Shots: Minnesota Medical Technologies has reported the US FDA’s 510(k) clearance to StaySure for the management of fecal incontinence (FI) A completed clinical trial demonstrated the device’s safety & efficacy, with a reduction in fecal incontinence frequency & improved QoL; full results are expected later in 2025 StaySure, marketed as Navina Insert in the EU, is…

ByRidhi RastogiJuly 25, 2025

NEWS

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Shots: Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology Approval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of…

ByRidhi RastogiJuly 23, 2025

NEWS

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Shots: Medtronic has received CE mark to extend label of MiniMed 780G system to pts (≥2yrs.), pregnant women & T2D pts; application is under the FDA’s review for T2D, plus US trial for use in pts (2-6yrs.) is underway Approval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…

ByRidhi RastogiJuly 22, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 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: Takeda AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant…

ByRidhi RastogiJuly 18, 2025

NEWS

Saluda Medical Reports Full Launch of EVA Sensing Technology for Spinal Cord Stimulation in the US

Shots: Saluda Medical has reported full commercial launch of EVA in the US following its approval in Dec 2024 Saluda Medical will present new clinical data on EVA and the Evoke SmartLoop System at ASPN 2025, featuring 11 abstracts, one oral presentation, & over 37 total publications, incl. 36-month efficacy results from the EVOKE Study…

ByRidhi RastogiJuly 17, 2025

NEWS

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 launch Accuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer…

ByRidhi RastogiJuly 17, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 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…

ByRidhi RastogiJuly 11, 2025

NEWS

Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study

Shots: Dymicron received the US FDA’s IDE approval to initiate a pivotal trial of Triadyme-C, a cervical artificial disc, to treat symptomatic cervical disc disease (SCDD) across leading US spine centers starting Q4’25 The study will compare the safety and effectiveness of Triadyme-C vs. anterior cervical discectomy and fusion (ACDF). The 1EP of the study…

ByRidhi RastogiJuly 11, 2025

NEWS

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 year Equinoxe Scapula Reconstruction System allows orthopedic surgeons to treat scapular fractures using single & dual plating techniques, which is compatible with any rTSA implant…

ByRidhi RastogiJuly 10, 2025

NEWS

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…

ByRidhi RastogiJuly 9, 2025

Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

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

Saluda Medical Reports Full Launch of EVA Sensing Technology for Spinal Cord Stimulation in the US

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

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

Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study

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

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

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