Cordis concludes patient enrolment in study of drug-eluting balloon
Patient enrolment has been completed in the post-market study of the SELUTION SLR DEB to treat patients with peripheral artery disease. Credit: Kateryna Kon / Shutterstock.com. Cordis has concluded patient enrolment in the SUCCESS PTA post-market study of the SELUTION SLR drug-eluting balloon (DEB) to treat patients with peripheral artery disease (PAD). The new sirolimus-eluting […]
JenaValve Trilogy heart valve meets primary endpoints in pivotal trial
The data from the trial will support the premarket approval application with the US Food and Drug Administration (FDA). Image Credit: mybox / Shutterstock. JenaValve Technology’s Trilogy transcatheter heart valve system met the prespecified non-inferiority criteria for the primary safety and efficacy endpoints in the ALIGN-AR trial. The data was presented at the 2023 Transcatheter […]
Boston Scientific’s EKOS system reduces bleeding in PE trial
Boston Scientific’s EKOS system showed a statistically significant reduction in major bleeding within seven days post-procedure when compared to the Inari system. Credit: Boston Scientific Corporation. Boston Scientific has announced that the REAL-PE study revealed patients treated with its EKOS Endovascular System for pulmonary embolism (PE) experienced reduced rates of major bleeding compared to those […]
ABK Biomedical announces treatment of first patient in Eye90 trial
The trial aims to assess the efficacy and safety of Eye90 microspheres in patients living with unresectable hepatocellular carcinoma. Credit: Nemes Laszlo / Shutterstock.com. ABK Biomedical has announced the treatment of the first subject in the Route90 US IDE pivotal study of Eye90 microspheres in hepatocellular carcinoma (HCC). Eye90 is claimed to be the first […]
ivWatch, Marathon sign distribution deal for monitoring technology
ivWatch’s patient monitoring technology helps protect patients from unpredictable IV complications. Credit: ivWatch, LLC / PRNewswire. Biosensor technology company ivWatch and Marathon Medical have signed a multi-year distribution agreement for the former’s patient monitoring technology in the US. ivWatch’s monitoring technology safeguards patients by detecting early IV infiltration and extravasation, reducing unpredictable complications. Under the […]
Trial sponsors say CROs need to own their mistakes and take responsibility
Trial sponsors have said that they want contract research organisations (CRO) to take more responsibility and own their mistakes when the service they provide falls short. That was the key theme of a panel discussion at the ongoing 11th Annual Clinical Trial Supply Nordics conference in Copenhagen. The panel discussion included executives from biotech and […]
FDA approves breast reconstruction trial using human ADM
US-based non-profit MTF Biologics said it will enrol patients undergoing mastectomy and implant-based breast reconstruction across sites in the US. Image credit: Shutterstock/STEKLO. The US Food and Drug Administration (FDA) has approved MTF Biologics’s trial using the FlexHD Pliable device in breast reconstruction after the agency granted an investigational device exemption (IDE). The clinical study, […]
FDA clears VUNO’s AI software for MRI brain scans
A 2023 report by GlobalData predicts that global revenue for AI platforms across healthcare will reach $18.8bn by 2027. Image credit: Shutterstock/Antonio Marca. The US Food and Drug Administration (FDA) has cleared VUNO’s Med-DeepBrain, an artificial intelligence (AI) tool that characterises brain structures from magnetic resonance imaging (MRI) scans. In a 24 October statement, South […]
Sponsors urged to compensate oncology patients and meet trial staff face-to-face
Traditionally oncology patients have not been compensated for participating in clinical trials. Credit: Shutterstock / Kunlanan Yarist Sponsors are being urged to compensate participants in oncological clinical trials, as well as make in-person visits to contract research organisations to keep exploratory studies from slowing down. Speaking to a full room at the 11th Annual Clinical […]
Promising future for precision medicine thanks to AI, biomarkers and technology
The precision medicine field is developing rapidly with technology bolstering that development. Image credit: Shutterstock / PopTika It has been over a decade since Emily Whitehead was declared cancer-free after the first successful, experimental CAR T-cell treatment, a moment which marked a huge development in precision medicine. Since then, the landscape has focused on CAR-T […]