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NEWS

Medtronic’s Altaviva Device Receives the US FDA’s Approval to Treat Urge Urinary Incontinence

Shots: The US FDA has approved the Altaviva device, an implantable tibial neuromodulation therapy to treat urge urinary incontinence Altaviva device is placed under the skin above the fascia & near the ankle in a minimally invasive, sedation & imaging-free procedure to restore bladder–brain communication & improve bladder control by delivering electrical impulses to the tibial…
September 22, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)   

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)    This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:    MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC  Read More: MAIA Biotechnology  Akeso Reports First…
September 19, 2025

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Amber implants
NEWS

Amber Implants Reports the US FDA’s 510(k) Clearance of VCFix Spinal System for Treating Vertebral Compression Fractures

Shots: The US FDA has granted 510(k) clearance to VCFix Spinal System for thetreatment of vertebral compression fractures The company plans to launch a US pilot program in early 2026, expand physician access later that year, extend the EXPAND trial into the US, & pursue EU label expansion for stand-alone use & one-level fixation integration…
September 17, 2025

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NEWS

Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the EU

Shots: J&J has launched Shockwave Javelin peripheral IVL catheter in the EU to modify calcium & cross extremely narrowed vessels in pts with peripheral artery disease (PAD) Shockwave Javelin was studied in FORWARD PAD IDE trial that demonstrated similar safety & effectiveness compared to balloon-based Shockwave IVL catheters, regardless of the nature of calcified lesions…
September 17, 2025

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NEWS

Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients

Shots: The US FDA has approved the PMA application for Idylla CDx MSI Test, a cartridge-based, fully automated “sample-to-result” companion diagnostic, with US launch anticipated soon & availability in other non-US markets to follow The Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…
September 17, 2025

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NEWS

Womed Reports the US FDA’s Approval of Womed Leaf to Treat Asherman Syndrome

Shots: The US FDA has approved the PMA application of Womed Leaf for women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions (Asherman syndrome); commercial launch expected in early 2026 Womed Leaf was evaluated in the PREG2 trial (n=160) for mod. to sev. intrauterine adhesions, showing reduced severity of intrauterine adhesion after hysteroscopic…
September 16, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 08, 2025 – Sep 12, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and DigiHealth. Check out our full report below:      AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC  Read More: AstraZeneca  Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L…
September 12, 2025

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NEWS

Tempus AI Receives the US FDA’s 510(k) Clearance for Updated Tempus Pixel Cardiac Imaging Platform

Shots: Tempus AI has received the US FDA 510(k) clearance for its updated Tempus Pixel, an AI-powered cardiac imaging platform, with the ability to generate T1 & T2 inline maps for enhanced cardiac MRI analysis Tempus Pixel delivers advanced viewing & automated reporting of cardiac MR images, improving efficiency and accuracy in flow visualization, functional…
September 12, 2025

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