Roche wins FDA approval for first test to detect malaria in blood donors
Nearly all US cases of malaria are linked to travel between countries endemic with the disease. Image credit: Shutterstock/mycteria. The US Food and Drug Administration (FDA) has approved a molecular test from Roche Diagnostics that screens blood donors for malaria. The agency’s approval is for the use of Roche’s cobas Malaria test on the polymerase […]
Oncology in 2024: The clinical trial trends reshaping the role of CROs
Oncology is the most active area in clinical trials globally this year, as more resources than ever are being dedicated to developing and testing new cancer treatments. At the same time, there is the recurring issue of patient recruitment and retention, which has become heightened due to the complexities involved with oncology clinical trials. All the more […]
Implantica gears up for FDA approval of acid reflux device
RefluxStop is an implantable, non-active, single-use device used in the laparoscopic treatment of GERD. Image Credit: Suttipun / Shutterstock. Implantica has started the premarket approval process with the US Food and Drug Administration (FDA) for its gastroesophageal reflux disease (GERD) treatment, RefluxStop. The Liechtenstein-based company is seeking approval for RefluxStop through the US FDA’s premarket […]
Cleerly touts new data for AI cardiovascular software
AI-QCT ISCHEMIA, when used in conjunction with Cleerly’s LABS software, can assess for atherosclerosis, stenosis, and ischemia, as per the 26 March press release. Credit: Prostock-studio via Shutterstock. Digital healthcare company Cleerly has announced that positive data from two studies investigating its AI-QCT ISCHEMIA software device has been published. Cleerly’s ISCHEMIA software device is an […]
Stemcell’s EasySep CD138 Selection Kit receives FDA de novo classification
Stemcell’s EasySep CD138 Positive Selection Kit is planned to be launched in the US, the European Union, Canada, and the UK. Credit: Business Wire/STEMCELL Technologies. The US Food and Drug Administration (FDA) has granted de novo classification to STEMCELL Technologies’ EasySep Human Bone Marrow CD138 Positive Selection Kit, a novel in vitro diagnostic (IVD) medical […]
FDA issues clearance to Calyxo’s redesigned CVAC System
The utilisation of the original CVAC Aspiration System in SURE proved effective in treating more than 1,500 patients in the US. Credit: Pixel-Shot/Shutterstock.com. The US Food and Drug Administration (FDA) has approved Calyxo’s redesigned CVAC System, a medical device aimed at enhancing the treatment of kidney stones through a minimally invasive approach. This new system […]
Wipro GE Healthcare plans $959m investment in India
Wipro GE Healthcare intends to boost its R&D and manufacturing capabilities. Credit: everything possible/Shutterstock.com. Wipro GE Healthcare has announced an investment of more than Rs80bn ($959m) in India, aimed at expanding its capabilities in medical device technology manufacturing. The investment, which is planned over the next five years, will see an increase in the company’s […]
Avicenna.AI wins two FDA clearances for AI tools in CT scans
Medical imaging is a major driver of AI’s growth in healthcare. Image credit: Shutterstock/K illustrator Photo. The US Food and Drug Administration (FDA) has granted clearance to two of Avicenna.AI’s tools that use AI to assist in pulmonary embolism and stroke assessment. The French medical imaging AI company has developed a host of tools that […]
Adjustable Band for Non-Occlusive Tubing Management
According to GlobalData’s company profile on Atrion, was a key innovation area identified from patents. Atrion‘s grant share as of January 2024 was 62%. Grant share is based on the ratio of number of grants to total number of patents. Adjustable band for non-occlusive tubing management in medical devices Source: United States Patent and Trademark […]
MRI-Guided System for Therapy Device Placement
According to GlobalData’s company profile on ClearPoint Neuro, Transcranial ultrasound was a key innovation area identified from patents. ClearPoint Neuro‘s grant share as of January 2024 was 46%. Grant share is based on the ratio of number of grants to total number of patents. Mri-guided system for precise placement of therapy devices Source: United States […]