(IN BRIEF) SGS Belgium NV has been officially designated by the European Commission and Belgian Competent Authority as a Notified Body (NB) under the In Vitro Diagnostic Medical Device Regulation (IVDR), EU 2017/746. This milestone enhances SGS’s ability to support … Read the full press release
Posted in Belgium, Business, Financial, Healthcare, Industrial, Investment, Management, News, Science, Switzerland, Technology
Tagged Belgium, certification, compliance, EU, EU IVDR, FAGG/AFMPS, Geofrey De Visscher, In Vitro Diagnostic, ISO 13485, IVDR, MDSAP, medical device, Medical Device Regulation, Notified Body, partnership, patient care, Regulation, SGS, UKCA
(IN BRIEF) Roche has launched a CE-marked Chest Pain Triage algorithm developed with Universitätsklinikum Heidelberg to improve emergency diagnosis of chest pain. Integrated into the navify® Algorithm Suite, the tool uses high-sensitivity cardiac troponin testing and ESC guidelines to support … Read the full press release
Posted in Artificial Intelligence (AI), Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged acute coronary syndrome, AI in healthcare, cardiac diagnostics, cardiovascular disease, CE-marked IVD, Chest Pain Triage Algorithm, digital diagnostics, digital health, EHR integration, emergency department, ESC guidelines, Healthcare Innovation, high-sensitivity troponin, hospital workflow optimization, Matt Sause, medical device, navify Algorithm Suite, patient triage, Roche, Universitätsklinikum Heidelberg
(IN BRIEF) EQT X fund has announced its acquisition of Zeus Company Inc., a pioneer in the design and production of fluoropolymer tubing for medical devices and select industrial applications. The acquisition aims to support Zeus’ continued growth as a … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, News, Science, Sweden, Technology
Tagged acquisition, EQT, Eric Liu, Ethan Waxman, John Groetelaars, medical device, partnership, Steve Peterson, Zeus Company
(IN BRIEF) TÜV Rheinland, an international third-party testing, inspection, and certification services provider, has awarded Ezisurg Medical Co., Ltd. its first MDR (Medical Device Regulation) certificate of conformity in Greater China for its “Disposable Powered Endoscopic Stapler and Cartridge.” This … Read the full press release
Posted in Awards, Business, Economy, Environment, Financial, Germany, Healthcare, Industrial, Investment, Management, News, Science, Technology
Tagged Awards, CHINA, Ezisurg Medical Co., Henry Nie, MDR Certification, medical device, Mohammed Dkhissi, partnership, Powered Endoscopic Stapler, sustainability, TÜV Rheinland, Wendy Geng
(NOTIZIA IN BREVE) La Banca europea per gli investimenti (BEI) ha investito 15 milioni di euro in Neuromod Devices Ltd per supportare la commercializzazione del suo dispositivo per il trattamento dell’acufene, Lenire. Il dispositivo ha ottenuto l’approvazione De Novo dalla … Read the full press release
Posted in Banks, European Union, Financial, Healthcare, Investment, Ireland, Pharma & Biotech
Tagged Alessio Beverina, bimodal neuromodulation device, De Novo, dispositivo di neuromodulazione bimodale, dispositivo medico, dispositivo per il trattamento dell'acufene, Dr. Manus Rogan, Dr. Ross O’Neill, European Investment Bank, FDA, Fountain Healthcare Partners, Lenire, medical device, Neuromod Devices Ltd, neuromodulation, neuromodulazione, Panakès Partners, Scientific Reports, TENT-A1, TENT-A2, Thomas Östros, tinnitus, tinnitus treatment device
(IN BRIEF) The European Investment Bank (EIB) has invested €15 million in Neuromod Devices Ltd to support the commercialization of its tinnitus treatment device, Lenire. The device has been granted De Novo approval from the US FDA and has shown … Read the full press release
Posted in Banks, European Union, Financial, Healthcare, Investment, Ireland, Pharma & Biotech
Tagged Alessio Beverina, bimodal neuromodulation device, De Novo, Dr. Manus Rogan, Dr. Ross O’Neill, European Investment Bank, FDA, Fountain Healthcare Partners, Lenire, medical device, Neuromod Devices Ltd, neuromodulation, Panakès Partners, Scientific Reports, TENT-A1, TENT-A2, Thomas Östros, tinnitus, tinnitus treatment device
(PRESS RELEASE) KFAR SABA, Israel, 9-Nov-2021 — /EuropaWire/ — Origami, a leading provider of no-code business process automation software for Medical Device and other industries, and citoQualis, a regulatory and business advisory leader for EU Medical Device companies, are announcing … Read the full press release
Posted in Healthcare, News, Pharma & Biotech
Tagged Amanda Brewster, business process automation, cGMP, citoQualis, EU MDR, EU regulatory, EU regulatory updates, GMP, GROWTH, ISO 13485, ISO 9001, IVDR, Life Science, Market Access, MDSAP, medical device, origami, patient safety, Pharmaceutical, QMS, Quality Management, Regulation (EU) 2017/745, Regulations, regulatory compliance, supply chain, US, Wolfgang Werner, Yaniv Shimony
The first Rhenium-SCT® treatment was accomplished by the interregional professional association for nuclear medicine in Hanau (PRESS RELEASE) HANAU, Germany, 4-Oct-2019 — /EuropaWire/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), … Read the full press release
Posted in Germany, Healthcare, News, Pharma & Biotech, Science, Technology
Tagged affordable skin cancer therapy, basal cell carcinoma, Basal Cell Carcinomas, Cancer, carcinomas, Dermatology, Dr. Holle, epidermal radioisotope therapies, epidermal radioisotope therapy, first Rhenium-SCT treatment Germany, Garching n. Munich, Hanau Rhenium-SCT treatment center, Healthcare, medical device, medicine, NMSC, non-invasive, Non-Melanocytic Skin Cancer, non-melanoma skin cancers, nuclear medicine, OncoBeta® GmbH, painless, painless non-invasive skin cancer treatment, painless skin cancer treatment, Pharma & Biotech, physician, radioisotope, radioisotope Rhenium-188, radionuclide therapy technology, Rehnium-188, Rhenium, Rhenium-188, Rhenium-SCT, science, Shannon D. Brown III, single-session, skin cancer, Squamous cell Carcinoma, Squamous Cell Carcinomas, technology
New recognition of OncoBeta’s success in developing and providing an innovative therapy for non-melanoma skin cancer patients. (PRESS RELEASE) Pasadena, CA, U.S.A., 5-Jul-2019 — /EuropaWire/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin … Read the full press release
Posted in Awards, Germany, Healthcare, News, Pharma & Biotech, Science, Technology
Tagged affordable skin cancer therapy, Award, basal cell carcinoma, Basal Cell Carcinomas, Cancer, carcinomas, Dermatology, epidermal radioisotope therapies, epidermal radioisotope therapy, Garching n. Munich, Healthcare, medical device, medicine, NMSC, non-invasive, Non-Melanocytic Skin Cancer, non-melanoma skin cancers, nuclear medicine, OncoBeta® GmbH, painless, painless non-invasive skin cancer treatment, painless skin cancer treatment, Pharma & Biotech, physician, radioisotope, radioisotope Rhenium-188, radionuclide therapy technology, Red Herring Top 100 North America Award, Rehnium-188, Rhenium, Rhenium-188, Rhenium-SCT, science, Shannon D. Brown III, single-session, skin cancer, Squamous cell Carcinoma, Squamous Cell Carcinomas, technology
The interregional professional association for nuclear medicine in Hanau is the first treatment center in Germany offering Rhenium-SCT® for the treatment of non-melanoma skin cancer (PRESS RELEASE) GARCHING N. MUNICH, Germany, 13-May-2019 — /EuropaWire/ — OncoBeta® GmbH, a commercial stage … Read the full press release
Posted in Germany, Healthcare, News, Pharma & Biotech, Science, Technology
Tagged 1st in Germany, affordable skin cancer therapy, basal cell carcinoma, Basal Cell Carcinomas, Cancer, carcinomas, Dermatology, Dr. med. Lutz-Hendrik Holle, epidermal radioisotope therapies, epidermal radioisotope therapy, Garching n. Munich, Germany, Hanau, Healthcare, medical device, medicine, NMSC, non-invasive, Non-Melanocytic Skin Cancer, non-melanoma skin cancers, nuclear medicine, OncoBeta® GmbH, painless, painless non-invasive skin cancer treatment, painless skin cancer treatment, Pharma & Biotech, physician, radioisotope, radioisotope Rhenium-188, radionuclide therapy technology, Rehnium-188, Rhenium, Rhenium-188, Rhenium-SCT, Rhenium-SCT treatment center, science, Shannon D. Brown III, single-session, skin cancer, Squamous cell Carcinoma, Squamous Cell Carcinomas, technology
(PRESS RELEASE) GENEVA, 12-Feb-2019 — /EuropaWire/ — The French Accreditation Committee (COFRAC) has just accredited SGS’s ultrasound measurement laboratory in Aix en Provence. In fact, it is even the first lab of this type in France to gain accreditation by COFRAC. Accreditation comes … Read the full press release
Posted in Electronics & Machinery, France, Healthcare, News, Pharma & Biotech, Switzerland, Technology
Tagged 25KHz, 30MHz, Aix en Provence, CB scheme, COFRAC, electromedical equipment, French Accreditation Committee, HIFU Equipment, IEC 60601-2-37, IEC 60601-2-5, IEC 60601-2-62, IEC 62127-1, implantable medical devices, ISO 14708-1, ISO/IEC 17025:2005, large frequency bandwidth, medical device, membrane hydrophones, precision scanning system, SGS, test equipment, transducers, ultrasonic exposure, Ultrasound Diagnostic Equipment, Ultrasound Field Measurement, ultrasound measurement, ultrasound power meter, ultrasound systems, Ultrasound Therapy Equipment, wideband PVDF needle
World Pharma Pricing and Market Access Congress 2018 Business Design Centre, London United Kingdom SOMERSET, N.J. / LONDON, UK, 19-Mar-2018 — /EuropaWire/ — Alliance Life Sciences, a leading global life sciences consulting, pricing data and technology provider, announced that it is … Read the full press release
Posted in France, Germany, Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology, United Kingdom
Tagged advanced therapies, AI, Alan Crowther, Alliance Life Sciences, Big Data, Biotech, Commercial Operations, Contracting, diagnostic firms, Global Pricing, life sciences companies, life sciences consulting, management software, Market Access, medical device, medical device firms, pharma, pharma pricing, Pharmaceutical, pharmaceutical manufacturers, ppma, ppmaconf, PricentricOne, PriceRight, rare diseases, Reimbursement, Sophie Ferronato, tender, Water Street Healthcare Partners, Water Street partners, World Pharma Pricing and Market Access Congress
Clinicians at the University Hospital Erlangen show how a new laser-based imaging technique termed MSOT can detect inflammation more accurately than current non-invasive diagnostic procedures and thereby help reduce the burden to patients MUNICH, 30-Mar-2017 — /EuropaWire/ — Ulcerative colitis … Read the full press release
Posted in France, Germany, Healthcare, Italy, Netherlands, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged Christian Wiest, Clinicians, Crohn's disease, Crohn's disease patients, detection of melanoma metastasis, diagnosis, diagnostic imaging, Dr. Ferdinand Knieling, hemoglobin values, IBD, inflammation, inflammatory bowel disease, intestinal mucosa, invasive endoscopy procedure, iThera Medical, laser light, laser-based imaging technique, medical device, medical imaging, MSOT, MSOT technology, Multspectral Optoacoustic Tomography, new diagnostic imaging modality, New England Journal of Medicine, non-invasive assessment, optoacoustic, optoacoustic imaging, photoacoustic, Prof. Dr. Maximilian Waldner, sentinel lymph nodes, suspicious breast lesions, Ulcerative colitis, ultrasound, University Hospital Erlangen
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