All articles by Vidya Sagar Maddela
Vidya Sagar Maddela
Cepheid gets FDA authorisation for its RNA-based hepatitis C test
Cepheid also received the Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for the Xpert HCV test, which runs on the GeneXpert Xpress System to detect hepatitis C virus RNA directly from a fingerstick sample
Paragonix unveils PancreasPak for donor pancreas preservation
PancreasPak organ preservation system, designed to protect and monitor donor pancreases during transportation, has already received the US Food and Drug Administration (FDA) 510(k) approval
Tempus secures FDA 510(k) approval for its AI tool to detect AF
Tempus ECG-AF is an AI-powered algorithm designed to analyse recordings of 12-lead electrocardiogram (ECG) devices, to detect signs associated with patients who are at risk of experiencing AF in the coming 12 months
SyntheticMR gets CE mark approval for SyMRI 15 imaging solution
SyMRI 15 hosts advanced applications integrated into SyMRI’s post-processing suite, including images that are proven to have the same capability as conventional for diagnostic use and offer even more value from the same sequence
First Patient Enrolled in Landmark Clinical Study to Assess3D Printed Models for Orthopedic Tumor Removal
Stratasys and Ricoh co-sponsor clinical study comparing the efficacy of 3D printed models to traditional CT or MRI scanning for bone tumor excision planning
AliveCor gets FDA approval for AI-powered 12-lead ECG System
Powered by KAI 12L technology, which leverages multiple deep neural network algorithms, the Kardia 12L ECG System features a reduced leadset that enables faster and easier detection of deadly cardiac conditions, including heart attacks
FDA Clears Clarius OB AI for Handheld Ultrasound: A Leap Forward in Prenatal Care
Clarius is on a mission to make accurate, easy-to-use, and affordable ultrasound tools available to all medical professionals in every specialty
Ayrton secures UK MHRA approval for its Nicotine Inhaler System
The company’s patented nicotine inhaler system is designed to deliver nicotine directly through the lungs to help smokers ultimately quit smoking
Endotronix granted FDA premarket approval for its Cordella PA Sensor
Cordella, which contains the Cordella Sensor and Cordella HF System, enables heart failure management in the home using pulmonary artery (PA) pressure, and non-invasive vital sign data to improve care decisions
Radical Imaging gets FDA approval for FlexView Diagnostic solution
FlexView Diagnostic is a Web-based DICOM medical image viewer that allows downloading, reviewing, manipulating, and visualising multi-modality medical image data, and can be integrated with healthcare facility software systems