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NEWS

Artrya Receives the US FDA’s 510(k) Clearance for Salix Coronary Plaque Module to Detect Coronary Artery Plaque

Shots: The US FDA has granted 510(k) clearance to the Salix Coronary Plaque module for the detection & quantification of coronary artery plaque; Salix is available since Jul 2025 in the US Also, Artrya is partnering with major US hospitals for the upcoming SAPPHIRE study, utilizing Salix Coronary Plaque module, plus it has signed a commercial…
August 22, 2025

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Agilent Technologies Reports the US FDA’s Approval of MMR IHC Panel pharmDx (Dako Omnis) as a Companion Diagnostic Test for Colorectal Cancer

Shots: Agilent Technologies has received the US FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic (CDx) test for colorectal cancer Agilent & BMS partnered to develop the MMR IHC Panel pharmDx (Dako Omnis) to identify dMMR colorectal cancer pts eligible for Opdivo monotx. or Opdivo + Yervoy treatment The…
August 21, 2025

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neurocare Receives the US FDA’s Clearance for Apollo TMS Therapy Devices to Treat Obsessive Compulsive Disorder

Shots: neurocare has received US FDA clearance for its Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices to treat obsessive-compulsive disorder (OCD) The Apollo TMS Therapy system is a non-invasive treatment that uses a magnetic coil on the head to stimulate targeted brain pathways and was previously cleared for major depressive disorder The systems support advanced…
August 21, 2025

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ONWARD Medical Receives FDA IDE Approval for ARC-IM System to Treat Blood pressure Instability in Spinal Cord Injury

Shots: ONWARD Medical has received the US FDA IDE approval to initiate its Empower BP study evaluating ARC-IM System for blood pressure instability in spinal cord injury The IDE trial will assess ARC-IM System in pts with C2–T6 spinal cord injuries, injury severities of AIS A-D & blood pressure instability, incl. chronic OH & autonomic…
August 19, 2025

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Galvanize Therapeutics Enrolls First Patient in PROPEL Registry Trial of Aliya Pulsed Electric Field Ablation for Soft Tissue Lesions

Shots: Galvanize Therapeutics has enrolled the first patient in the PROPEL registry trial evaluating the Aliya Pulsed Electric Field ablation system for soft tissue lesions, including primary and metastatic lung, liver, & other organ tumors Trial will evaluate clinical application, safety, perioperative outcomes, & radiographic response of the Aliya PEF system in ~1000 pts over…
August 18, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 11, 2025 – Aug 14, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Animal Health, and Biosimilars. Check out our full report below:    Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease  Read More: Novartis  Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR)…
August 14, 2025

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BioCardia Collaborates with CART-Tech to Advance Heart3D Fusion Imaging for Interventional Cardiology

Shots: BioCardia has entered into an exclusive development & commercialization agreement with CART-Tech for Heart3D Fusion Imaging to improve 2D x-ray images used for cardiac biotherapeutic delivery & biopsy procedures As per the deal, BioCardia secured global exclusive rights to CART-Tech’s IP for biotherapeutic interventions, plus exclusive US distribution rights for cardiac biopsy & global…
August 14, 2025

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Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma

Shots: Myra Vision received the US FDA conditional IDE approval to initiate its ADAPT study evaluating Calibreye Titratable Glaucoma Therapy (TGT) surgical system for glaucoma The IDE trial will evaluate the safety and efficacy of Calibreye TGT surgical system in ~70 refractory glaucoma pts with 12mos. primary effectiveness endpoint Calibreye System allows ophthalmologists to control…
August 13, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 04, 2025 – Aug 08, 2025) 

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Biotech, M&A and Biosimilars. Check out our full report below:   Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD)  Read More: Roche   Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma  Read…
August 8, 2025

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