TÜV Rheinland: Notified Body for the New Medical Device Regulation

TÜV Rheinland LGA Products GmbH is now a notified body for the EU Medical Device Regulation (MDR) 2017/745 / Introduction of Eudamed central database / Increased requirements for notified bodies

TÜV Rheinland LGA Products GmbH is now a notified body for the EU Medical Device Regulation (MDR) 2017/745 / Introduction of Eudamed central database / Increased requirements for notified bodies

RadCalc 3D Monte Carlo calculations for photons begins beta testing

Beta Testing Begins of RadCalc 3Dmc version 7.1.1.0 utilizing Monte Carlo 3D dose volume QA technology acquired from McGill University Inventors

Beta Testing Begins of RadCalc 3Dmc version 7.1.1.0 utilizing Monte Carlo 3D dose volume QA technology acquired from McGill University Inventors

APOLLO MR3T Laser Receives FDA 510(k) Clearance

APOLLO room lasers are the most frequently used positioning lasers for radiation therapy worldwide. Now the MR-safe version, APOLLO MR3T, has also been registered as a medical device under a 510(k) approval. The MR-compatible room laser is currently the only product of its class approved by the FDA. APOLLO MR3T are high-precision room lasers for … „APOLLO MR3T Laser Receives FDA 510(k) Clearance“ weiterlesen

AESKU.GROUP Completes Acquisition of MBL Bion

AESKU.GROUP finalized acquisition of immunofluorescence assay specialist MBL Bion, expanding IFA product menu and production operations

AESKU.GROUP finalized acquisition of immunofluorescence assay specialist MBL Bion, expanding IFA product menu and production operations

BayPAT’s Licensee Recardio already in Phase 2 Regenerative Post-Myocardial Infarction Trial of Dutogliptin in Europe and USA

BayPAT, a service provider offering services in the area of technology transfer, IP management and commercialisation, today announced that its licensee Recardio is already in the Phase 2 study for regenerative therapy in early recovery post-myocardial infarction in Europe and USA. The regenerative therapy concept of Recardio with its DPP-IV inhibitor dutogliptin is subject to … „BayPAT’s Licensee Recardio already in Phase 2 Regenerative Post-Myocardial Infarction Trial of Dutogliptin in Europe and USA“ weiterlesen

First Patients Enrolled into the MOCA I Trial

CorFlow Therapeutics AG ("CorFlow") today announced that the first two patients have been enrolled into the First-in-Man (FIM) MOCA I clinical trial.  The first MOCA (Microvascular Obstruction with the CoFITM System Assessment) trial is a safety and feasibility trial assessing the CorFlow Controlled Flow Infusion (CoFITM) System. In the first roll-in phase, non-acute (NSTEMI) patients will undergo microvascular … „First Patients Enrolled into the MOCA I Trial“ weiterlesen

Umstrukturierung der rumänischen Gesundheitsbehörde erweckt klinische Studien in Rumänien zu neuem Leben

In den vergangenen Jahren mussten Pharmaunternehmen unvorhersehbare und zunehmend längere Bearbeitungszeiten für die Genehmigung klinischer Studien in Rumänien in Kauf nehmen. Infolgedessen ging die Anzahl der klinischen Studien in Rumänien deutlich zurück. Jetzt hat die zuständige Behörde, die National Agency for Medicines and Medical Devices (NAMMD), sehr vielversprechende Zahlen veröffentlicht. Der signifikante Anstieg der Zulassungen … „Umstrukturierung der rumänischen Gesundheitsbehörde erweckt klinische Studien in Rumänien zu neuem Leben“ weiterlesen