Credit: GE HealthCare

GE HealthCare has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new deep learning-based image processing software, Precision DL.  

As part of the company’s Effortless Recon DL portfolio, the new software offers image quality performance benefits that are generally linked with hardware-based Time-of-Flight (ToF) reconstruction. 

These benefits include improved quantitative accuracy, contrast-to-noise ratio and contrast recovery. 

GE HealthCare imaging president and CEO Jan Makela said: “Clinicians are seeing the value of applying deep learning technology to enhance image quality with our multi-modality family of Effortless Recon DL applications, which already includes AIR Recon DL for MR, TrueFidelity for CT and Helix DL for X-ray. 

“Now we are proud to add Precision DL for PET/CT, enabling more precise and personalised care across healthcare systems’ imaging departments.” 

Ezra has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new artificial intelligence (AI) technology, Ezra Flash, for use in brain imaging. 

Ezra Flash is designed to improve the quality of magnetic resonance imaging (MRI).

The new AI technology will allow the company to launch the 30-minute full-body MRI scan, which is claimed to be the first of its kind across the world. 

A rapid MRI protocol that was developed by the company generates noisy images. Ezra Flash can address this issue by improving the quality of these images. 

Ezra founder and CEO Emi Gal said: “Our mission at Ezra is to detect cancer early for everyone in the world and I’m really excited about this new AI enabling us to make our scan more affordable. 

“By boosting quality while reducing scan time, we’re decreasing our cost for a full body MRI by 30% and we’re passing these cost savings to our customers.” 

The US Food and Drug Administration (FDA) has granted CardioRenal’s potassium measuring device breakthrough device designation. 

The Tenor device integrates potassium measuring technology with an app and cloud capabilities to provide remote potassium analysis monitoring for patients living with chronic kidney disease. 

According to Grenoble, France-based CardioRenal, the device is designed to be easily used by elderly patients in a range of locations and provide results in less than five minutes.

Remote monitoring is a fast-growing market – GlobalData predicts it will be worth $760m by 2030. Tenor, designed to be used with the FDA-cleared Tasso blood collection device, will aid those living with chronic kidney disease by allowing doctors to remotely access data gathered by the patient.

Invivoscribe has partnered with Complete Genomics to develop and commercialise biomarker tests for cancer and oncology research. 

The partnership will use next-generation sequencing (NGS) platforms from Complete Genomics to develop new tests. 

As per the agreement, Invivoscribe will develop biomarker tests, including test controls and related bioinformatics software.

These biomarker tests will be utilised to screen research specimens upfront. Other applications include surveillance, monitoring and detection of measurable residual disease (MRD) in a clinical research environment. 

The biomarker tests will initially be launched globally for research use only. 

Invivoscribe CEO and CSO Jeffrey Miller said: “Our LeukoStrat CDx FLT3 Mutation Assay is an internationally standardised, FDA and IVDR-approved PCR-based capillary test that has proven invaluable as a companion diagnostic for three approved FLT3 targeted therapies. 

“Though it is available worldwide both as a kit and as a testing service in our LabPMM laboratories, in order to study and monitor the level of AML disease following the identification of FLT3-positive AML subjects, we also need to provide a highly sensitive NGS-based FLT3 test.” 

Trajan Scientific and Medical (Trajan) has received approval for two new Neoteryx remote blood microsampling devices for clinical application in Europe and the UK. 

The two approved devices, namely Mitra and hemaPEN, met all the necessary safety and performance requirements of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and the In Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe. 

After receiving the CE mark, the company plans to extend the capabilities of its microsampling products. 

The improved products will be able to support person-centred, decentralised, minimally invasive blood collection in both research and clinical settings. 

Trajan founder and CEO Stephen Tomisich said: “The updated regulatory approval of Trajan’s blood microsampling devices in the UK and European Union is another step forward towards our vision of personalised, preventative data-based healthcare. 

“Our growing range of microsampling technologies allows almost anyone to take an analytically viable sample outside the clinical setting, anytime, anywhere. In our view, that is essential to enable the healthcare systems of the future.”