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AliveDx
NEWS

AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray

Shots: The US FDA has received 510(k) application for MosaiQ AiPlex CTDplus multiplex microarray to improve & accelerate diagnosis of connective tissue diseases (CTDs) CTDplus diagnose CTDs using just 10μL of sample in one step, with its CTD microarray having 15 markers in each panel per pts—DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P,…
April 7, 2025

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Medivis
NEWS

The US FDA Grants 510(k) Clearance to Medivis’ Spine Navigation Platform

Shots: The US FDA has granted 510(k) clearance to Spine Navigation platform; commercially launched in the US, making it available nationwide to hospitals & ambulatory surgical centers Spine Navigation integrates AI-driven surgical intelligence, real-time insights, & advanced imaging with lightweight AR hardware allowing surgeons ergonomic freedom using hand tracking & voice control in neuro &…
April 3, 2025

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EchoIq, Sciimage & Medaxiom
NEWS

Echo IQ Enters into Strategic Partnership And Integration Agreements With ScImage And MedAxiom for EchoSolv AS

Shots: This collaboration will broaden the availability of EchoSolv AS, integrating its AI cardiology technology into a wide network of US hospitals and cardiology practices As per the agreement, EchoSolv AS will be deployed across 36 MedAxiom/ScImage-affiliated hospitals and cardiology practices, providing physicians access to AI-driven diagnostics via ScImage's image management and workflow platform. By leveraging…
April 1, 2025

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Visby Medical
NEWS

Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

Shots: The US FDA has granted De Novo authorization to Visby Medical Women's Sexual Health Test for OTC use Clinical studies with 2,000+ users showed that the test offers comparable accuracy to laboratory-based PCR machines, whereas its companion app guides users through testing, interpretation of results, & provides further care options Visby Medical Women's Sexual…
March 31, 2025

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Huntleigh
NEWS

Huntleigh Healthcare Reports the US FDA’s 510(k) Clearance of Dawes-Redman CTG Analysis to Improve Non-Stress Test Interpretation in Fetuses

Shots: The US FDA has granted 510(k) clearance to the Dawes-Redman CTG analysis, improving non-stress test (NST) interpretation in fetuses to help prevent poor outcomes for babies & families Dawes-Redman CTG assesses NST traces against criteria of normality, using database of 100,000+ traces & their outcomes, by evaluating basal heart rate, sinusoidal rhythms, & short-term…
March 26, 2025

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Avatar Medical & FX Shoulder Solutions
NEWS

Avatar Medical & FX Shoulder Solutions Reports the US FDA’s 510(k) Clearance of brAIn Shoulder Positioning System (SPS) for Arthroscopic Surgeries

Shots: The US FDA has granted 510(k) clearance to brAIn SPS for preoperative planning & implant placement in shoulder surgery brAIn SPS, developed via FX & Avatar, combines AI-driven imaging, with 3D avatar visualization for precise soft tissue assessment to optimize implant positioning & joint function while enhancing accuracy & recovery in comparison to conventional…
March 25, 2025

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Johnson & Johnson
NEWS

J&J MedTech Reports the US FDA‘s 510(k) Clearance of MONARCH QUEST for Robot-Assisted Bronchoscopy

Shots: The US FDA has granted 510(k) clearance to MONARCH QUEST, an AI-powered navigation tech for improved robotic-assisted bronchoscopy MONARCH QUEST features a scope-in-sheath design & continuous vision, utilizing NVIDIA RTX platform to boost its computational power by 260% for enhanced accuracy. It also allows integration with GE HealthCare’s OEC 3D CBCT Imaging System to…
March 17, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (March 10, 2025 – March 13, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars & Animal Health. Check out our full report below:   Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025  Read More: Incyte  Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at…
March 13, 2025

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Johnson & Johnson
NEWS

J&J MedTech Reports the US FDA‘s 510(k) Clearance of MONARCH QUEST for Robot-Assisted Bronchoscopy

Shots: The US FDA has granted 510(k) clearance to MONARCH QUEST, an AI-powered navigation tech for improved robotic-assisted bronchoscopy MONARCH QUEST features a scope-in-sheath design & continuous vision, utilizing NVIDIA RTX platform to boost its computational power by 260% for enhanced accuracy. It also allows integration with GE HealthCare’s OEC 3D CBCT Imaging System…
March 13, 2025

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