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Bruno Vision Care
NEWS

Bruno Vision Care’s Deseyne Contact Lens Secures the US FDA’s Approval for Dry Eye Disease

Shots: The US FDA has approved Deseyne (vifilcon C) daily disposable contact lens with FusionTechnology; commercially available in Q4’25 Deseyne lenses integrates 2 patented innovations: vifilcon C hydrogel material & FusionTechnology, to gradually release embedded Lachryceuticals (incl. amino acids, vitamins, & polysaccharides), ensuring sustained bioavailability & long-lasting eye comfort FusionTechnology combines hyaluronic acid & tamarind…
April 15, 2025

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Innoblative
NEWS

Innoblative Secures the US FDA’s IDE Approval of SIRA Electrosurgical Device for Breast Cancer Patients

Shots: The US FDA has granted IDE approval to initiate US feasibility study of SIRA radiofrequency ablation (RFA) electrosurgical device for pts undergoing breast-conservation surgery (BCS) SIRA device is a single-use applicator designed to deliver circumferential RFA to the post-lumpectomy cavity during breast-conserving surgery to provide consistent ablation depth & increased confidence in margin treatment…
April 14, 2025

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Elixir Medical
NEWS

Elixir Medical Reports European MDR CE Mark Approval & Launch of LithiX Hertz Contact IVL System

Shots: Elixir has reported European MDR CE Mark approval & commercial launch of LithiX Hertz Contact (HC) Intravascular Lithotripsy (IVL) System in EU to improve calcium & percutaneous coronary intervention treatment LithiX is a transcatheter device that uses low-profile metal hemispheres on a semi-compliant balloon to apply HC Stress, creating deep & wide fractures while…
April 11, 2025

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Merit Medical
NEWS

Merit Medical Reports the US Launch of Ventrax Delivery System

Shots: Merit Medical has launched its Ventrax delivery system in the US Ventrax is designed to streamline retrograde aortic access by guiding ablation catheters into the left ventricle, helping in procedures that are used to treat ventricular tachycardia Ventrax Delivery System features a 95cm sheath for targeted access, an ultralow-profile sheath-to-dilator transition for smooth insertion,…
April 10, 2025

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Womed, Kebomed & Saescomedical
NEWS

Womed Collaborates with Kebomed Europe & Saesco Medical to Launch Womed Leaf in Europe

Shots: Womed has entered into licensing agreements with Kebomed Europe & Saesco Medical to distribute Womed Leaf, an intrauterine adhesion barrier film, across Europe As per the agreement, Kebomed will handle distribution across France, Germany, Sweden, Denmark, Norway, Finland, Austria & Switzerland, while Saesco Medical will oversee commercialization in Spain, Italy, Portugal, Belgium, the Netherlands…
April 9, 2025

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J&J Medtech
NEWS

J&J MedTech Reports First Patient Enrollment in FORWARD CAD trial of Shockwave Javelin Coronary IVL Catheter

Shots: Shockwave Medical (J&J MedTech’s company) has initiated the pivotal FORWARD CAD IDE trial with first pts enrolled, evaluating safety & efficacy of the Shockwave Javelin coronary IVL catheter to treat calcified, hard-to-cross de novo coronary artery lesions prior to stenting    Trial will evaluate the coronary IVL catheter in ~158 pts with mod. to…
April 8, 2025

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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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