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Exact Sciences
NEWS

Exact Sciences launches Oncodetect for Molecular Residual Disease (MRD) Detection

Shots: Exact Sciences has launched Oncodetect to detect MRD across multiple solid tumors, with its efficacy supported by strong clinical validation, incl. ~5yrs. of follow-up data from the Alpha-CORRECT study Addiitonally, clinical & analytical validation studies across multiple solid tumors are underway, supported by strategic partnerships for multi-cancer evidence generation Oncodetect test provides clear “Detected”…
April 22, 2025

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Ceribell
NEWS

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Shots: The US FDA has granted 510(k) clearance to Clarity algorithm for the detection of electrographic seizures in pts (≥1yrs.) Pediatric clearance was backed by extensive electroencephalography (EEG) dataset developed from ~1,700 pts to detect non-convulsive seizures, ensuring rapid diagnosis & prevention of serious brain injury Clarity algorithm allows seizure detection in both pediatric &…
April 17, 2025

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Carmat
NEWS

The US FDA Grants Conditional Approval to Initiate Second Cohort of the EFS Study of CARMAT’s Aeson Artificial Heart

Shots: The US FDA has granted conditional approval to initiate the second cohort of the early feasibility study (EFS) of the Aeson artificial heart in the US by H2’25, pending ethics committee approval & personnel training; launch expected by 2028 EFS is being conducted in 2 cohorts; first (n=3) was completed in Q3’21, leading to FDA-approved…
April 15, 2025

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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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