Category Archives: Clinical Trials & Medical Discoveries

FAST Study Demonstrates High Diagnostic Accuracy of CAAS vFFR and Received USA 510(k) Market Clearance

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MAASTRICHT, Netherlands, May 22, 2018 /PRNewswire/ — A highly innovative software, developed by Pie Medical Imaging – PMI – B.V. (Esaote Group) will be presented at EuroPCR 2018, the world-leading course in interventional cardiovascular medicine, held in Paris, Palais des Congrès (France) between 22 – 25 May 2018.

FAST-Studie weist hohe Diagnosegenauigkeit von CAAS vFFR nach und erhält die 510(k)-Zulassung in den USA

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MAASTRICHT, Niederlande, May 22, 2018 /PRNewswire/ — Eine von Pie Medical Imaging – PMI – B.V. entwickelte hoch innovative Software wird beim EuroPCR 2018, der international führenden Fortbildungsveranstaltung für interventionelle Kardiologie vorgestellt, die vom 22. bis zum 25. Mai 2018 in Paris, Palais des Congrès (Frankreich) stattfindet.

L'étude FAST fait la preuve de la haute précision diagnostique du CAAS vFFR qui obtient le feu vert 510(k) de la FDA pour sa mise sur le marché.

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MAASTRICHT, Pays-Bas, May 22, 2018 /PRNewswire/ — Un logiciel hautement innovant, développé par PMI (Pie Medical Imaging B.V.) sera présenté à l’EuroPCR 2018, l’événement de renommée mondiale dans le domaine de la médecine cardiovasculaire interventionnelle qui se tiendra à Paris, au Palais des Congrès (France) du 22 au 25 mai 2018.

Lo studio clinico FAST dimostra elevata accuratezza diagnostica del software CAAS vFFR, che ha ricevuto dagli Stati Uniti l'autorizzazione alla commercializzazione FDA 510 (k)

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MAASTRICHT, Paesi Bassi, May 22, 2018 /PRNewswire/ — Un software altamente innovativo, sviluppato da Pie Medical Imaging – PMI – BV (Gruppo Esaote) sarà presentato al congresso EuroPCR 2018, il maggiore corso mondiale nel campo della medicina cardiovascolare interventistica, che si terrà a Parigi, Palais des Congrès (Francia) il 22 – 25 Maggio 2018.

ReCor Medical To Release of Clinical Trial Results 23 May at EuroPCR in Paris

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PALO ALTO, Calif., May 17, 2018 /PRNewswire/ — ReCor Medical announced today that it will present the primary outcomes data from the SOLO study of its RADIANCE Global Clinical Trial Program of the Paradise®  Ultrasound Renal Denervation System for patients with hypertension during the Late Breaker Sessions at the EuroPCR 2018 Meeting in Paris on 23 May.

Merck KGaA, Darmstadt, Germany Data at ASCO 2018 to Showcase Progress and Further Optionality of Oncology Pipeline

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DARMSTADT, Germany, May 16, 2018 /PRNewswire/ — Not intended for UK-based media ASCO Abstract # Avelumab: 9507, 9537, 9090, 9008, 8563, 3057, 4544, e21531, e13603, e18932, e21623, e21620, e21544; tepotinib (c-Met kinase inhibitor): 9082, 9016; M6620 (ATR inhibitor): 2549, e21048; M3814 (DNA-PK): 2518 M7824 (TGF-ß trap/anti-PD-L1): 3007, 9017, 2566; M2698 (dual p70S6k/Akt inhibitor): 2584

Résultats à 6 mois exceptionnels pour le MINIject d'iSTAR Medical dans le premier essai clinique chez l'homme

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WAVRE, Belgique, 17 mai 2018 /PRNewswire/ — iSTAR Medical SA, une société privée de dispositifs médicaux développant des implants ophtalmiques innovants pour le traitement du glaucome, a annoncé aujourd’hui des résultats à six mois exceptionnels pour leur premier essai de chirurgie micro-invasive du glaucome (MIGS) chez l’homme avec le dispositif MINIjectTM dans une utilisation en « stand-alone ». Les résultats…

MINIject von iSTAR Medical liefert hervorragende Halbjahresergebnisse in der ersten klinischen Humanstudie

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WAVRE, Belgien, 17. Mai 2018 /PRNewswire/ — iSTAR Medical SA, ein privates Medizintechnikunternehmen, das neuartige ophthalmologische Implantate zur Behandlung des Glaukoms entwickelt, gab heute die hervorragenden Halbjahresergebnisse seiner ersten humanen (FIH: first-in-human) Studie zur mikroinvasiven Glaukomchirurgie (MIGS) unter eigenständigem Einsatz des Systems MINIject™ bekannt. Die Ergebnisse zeigen, dass MINIject sicher und hochwirksam zu einer signifikanten…

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

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SILVER SPRING, Md., May 11, 2018 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.

New Phase 3 Data Show Esketamine Nasal Spray Demonstrated Rapid Improvements in Depressive Symptoms in Patients with Treatment-Resistant Depression

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TITUSVILLE, N.J., May 5, 2018 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the results from two Phase 3 clinical studies of the investigational compound esketamine nasal spray in patients with treatment-resistant depression. These studies will be presented at the American Psychiatric Association Annual Meeting, taking place May 5-9 in New York,…