NeuroPace completes enrolment in pivotal trial for neuromodulation therapy
NeuroPace’s therapy already gained FDA approval in 2014 for the treatment of adults with partial onset seizures who have not responded to two or more antiepileptic drugs. Image credit: Shutterstock/Andrus Ciprian. NeuroPace has completed enrolment in a pivotal study investigating its neuromodulation therapy for the treatment of idiopathic generalised epilepsy. The US-based medtech company said […]
Lindis Blood Care announces successful conclusion of blood salvage trial
The Remove study is investigating the company’s Catuvab device, designed to remove cancerous cells from a patient’s blood whilst undergoing cancer related surgery. Credit: Shutterstock / PIJITRA PHOMKHAM. German medical technology company Lindis Blood Care has announced that the last patient participating in its trial of the removal of tumour cells from surgical shed blood […]
10 MedTech stories that made headlines in 2023
Shutterstock: 3rdtimeluckystudio It has been another challenging year for the industry, with cybersecurity issues, tech defects, industry layoffs and supply chain concerns all making headlines. But some exciting breakthroughs and innovations have also made waves. We highlight the top stories of 2023. GE HealthCare spin-off Back in January, GE Healthcare made its debut as a stand-alone company, […]
AXIM and Auer partner for Dry Eye Disease assays production
The assays are designed to deliver results within nine minutes. Credit: Michal Jarmoluk from Pixabay. AXIM Biotechnologies has signed an agreement with Auer Precision to scale up the production of its two diagnostic assays for dry eye disease (DED). This partnership aims to meet the growing demand for the assays, ocular T-POC TOTAL IgE Immunoassay […]
Gore implants first subject in ascending stent graph study
The aortic stent graft market is is expected to grow to $2.1bn by 2030 in the US. Credit: stefanamer via Getty Images. US-based W L Gore and Associates (Gore) has implanted the first subject in the ARISE II study of its ascending stent graft, for patients who require endovascular treatment of the ascending aorta. The […]
FDA grants breakthrough designation for Bladder CARE Assay
The non-invasive assay is designed for the quantitative urine-based detection of bladder cancer. Credit: mi_viri / Shutterstock.com. The US Food and Drug Administration (FDA) has granted breakthrough device designation for Pangea Laboratory’s Bladder CARE Assay. This non-invasive assay is designed for the quantitative detection of bladder cancer using urine samples, and upper tract urothelial carcinoma […]
Pulse Biosciences concludes procedures with cardiac catheter
The first five patients treated with the technology will be monitored to evaluate the treatment. Credit: JAFAR AHMED on Unsplash. Pulse Biosciences has announced the successful completion of the first-in-human procedures using its new CellFX nsPFA cardiac catheter. This marks a significant milestone in the company’s feasibility study for the treatment of atrial fibrillation. The […]
ulrich medical USA receives expanded approval for spinal systems
The Momentum and Momentum MIS posterior spinal fixation systems and V-STEADY Bone Cement. Credit: ulrich medical USA / PRNewswire. Spine technology company ulrich medical USA has received clearance from the US Food and Drug Administration (FDA) for expanded indications of its Momentum and Momentum MIS posterior spinal fixation systems. This approval allows the systems to […]
Boomerang hits milestone in pilot study of neurostimulator implant for IBD
US-based Boomerang’s device was granted breakthrough device designation by the US Food and Drug Administration (FDA) in March 2023. Image credit: Shutterstock/SewCreamStudio. Boomerang Medical has completed stage two enrolment of a pilot study investigating the use of its bioelectronic technology to treat inflammatory bowel disease (IBD). Boomerang Medical said the BOOM-IBD clinical trial (NCT05414955) has […]
Quest introduces test panel for novel psychoactive substances
The new confirmatory testing service helps identify possible misuse of controlled medications, including opioids and other substances. Credit: totojang1977 / shutterstock.com. Quest Diagnostics has introduced the new 88-compound psychoactive substance test panel to aid healthcare providers in identifying potential misuse of drugs in patients prescribed controlled medications. The new confirmatory testing service for novel psychoactive […]