Roche secures CE mark for companion diagnostic for cancer therapy Enhertu
Roche’s Ventana HER2 test can be used to identify patients with low human epidermal growth factor receptor 2 (HER2) expression. Image Credit: Michael Vi / Shutterstock. Roche has received a European Union CE mark for the companion diagnostic for Daiichi Sankyo’s and AstraZeneca’s Enhertu (trastuzumab deruxtecan), Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx (Ventana […]
Proprio and Biedermann collaborate on surgical technology
Proprip’s Paradigm system offers real-time, 3D anatomical visualisation to surgeons. Credit: Proprip. AI-powered surgical technology company Proprio has entered a strategic partnership with Biedermann Group to fast-track innovation in spine surgery. The collaboration will focus on integrating Biedermann’s spinal implants with Proprio’s Paradigm system, which leverages computer vision, AI and augmented reality for enhanced surgical […]
Myriad’s GeneSight test proves effective in new study data
Myriad’s GeneSight Psychotropic test is used for over 60 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. Credit: PeopleImages.com – Yuri A via Shutterstock. Myriad Genetics has announced results from a study indicating that fewer patients were prescribed medications with gene-drug interactions after taking the GeneSight Psychotropic test. Myriad’s GeneSight Psychotropic test […]
US federal court issues decree barring Philips from ventilator industry
The permanent injunction levelled against Philips comes following a series of class one recalls, the most serious kind. Credit: Shutterstock / Dutchmen Photography A US federal court has entered a consent decree of permanent injunction against medtech giant Philips and its various subsidiaries preventing the company from re-entering the positive airway pressure (CPAP) machine and […]
US FDA clears Neurovalens’ Modius Stress device to treat anxiety
Neurovalens can now market the non-invasive device in the US. Credit: Neurovalens. Neurovalens has secured clearance from the US Food and Drug Administration (FDA) for its Modius Stress device, designed to treat generalised anxiety disorder (GAD). This marks the company’s second FDA-approved product, following the Modius Sleep device for insomnia. Neurovalens can now market the […]
TCAI implements pulsed field ablation system for atrial fibrillation
TCAI also has conducted the first case using a second commercially approved PFA system. Credit: Gorodenkoff/Shutterstock.com. The Texas Cardiac Arrhythmia Institute (TCAI) at St David’s Medical Center has implemented a new pulsed field ablation (PFA) system for treating patients with paroxysmal and persistent atrial fibrillation. With this development, TCAI became the first in the US […]
Challenges and solutions in the POC test market 2024
Whilst the sudden and unprecedented spike in demand for point-of-care (POC) testing necessitated by the COVID-19 pandemic is set to wane, the future looks bright for the POC devices market overall. POC tests have been a staple of healthcare for decades, even before the pandemic. A pregnancy test is a classic example of a disposable […]
SimBioSys introduces clinical decision tool for breast cancer
The new tool is expected to provide a data-driven approach to surgical planning for more than 270,000 patients a year diagnosed with breast cancer. Credit: Yuganov Konstantin/Shutterstock.com. SimBioSys has launched TumorSight Plan, a clinical decision support tool designed to help enhance surgical planning for early-stage breast cancer. It is said to be the first clinical […]
mHealth apps and healthcare access
In the chronic disease management space, regulated mHealth apps play a pivotal role in facilitating continuous monitoring and support for patients. Credit: Agenturfotografin via Shutterstock. In today’s digital age, mobile health (mHealth) apps have become influential tools that revolutionise healthcare delivery and empower individuals to manage their health effectively. When properly regulated, these apps improve […]
SpineX eyes FDA submission as neurogenic bladder trial hits milestone
Neurogenic bladder is an umbrella term for urinary conditions due to loss of nerve signalling between it and the central nervous system. Image credit: Orawan Pattarawimonchai. SpineX has closed recruitment for a clinical study investigating its neuromodulation device to treat urinary incontinence. Data from the trial, which began in May 2022, will be used to […]