November’s top news stories

6 December 2019 (Last Updated December 12th, 2019 11:24)

Researchers at the University of Toronto and Arizona State University have developed a direct gene-circuit-to-electrode interface for the conversion of biological information into an electronic signal, and Zebra Medical Vision has secured 510(k) clearance from the US FDA for its AI-powered HealthCXR device. Medicaldevice-network.com wraps up key headlines from November 2019.

November’s top news stories
U of T members of the interdisciplinary team (from left to right): Peivand Sadat Mousavi, Jenise Chen, Shana Kelley and Keith Pardee Credit: Steve Southon

Researchers develop direct gene-circuit-to-electrode interface

Researchers at the University of Toronto and Arizona State University have developed a direct gene-circuit-to-electrode interface for the conversion of biological information into an electronic signal.

The electrochemical platform combines cell-free synthetic biology with nanostructured electrodes.

The interface combines the sensing capability of biological systems with the decision-making capabilities of electronic systems.


Zebra Medical Vision gets approval for HealthCXR imaging device

Israel’s Zebra Medical Vision has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-powered HealthCXR device, which enables identification and triaging of pleural effusion in chest X-rays.

In May, the company also received FDA clearance for its AI-powered chest X-ray triage product, HealthPNX.

The latest product adds to Zebra’s expanding AI1 lot of triage and prioritisation applications for chest X-rays.


Philips announces trial to evaluate Direct to Angio Suite impact

Royal Philips (Philips) has announced a clinical study to evaluate the effect of a ‘Direct to Angio Suite’ workflow on outcomes of stroke patients.

WE-TRUST (Workflow optimisation to rEduce Time to endovascular ReperfUsion in Stroke Treatment) is a multicentre, prospective, randomised, controlled, open-label, blinded-endpoint study, which will evaluate if Philips’ advanced image-guided therapy platform can diagnose, plan and treat stroke patients in the interventional suite without needing an initial CT or MRI exam.

The trial will begin in the first half of 2020, with expected completion in 2022. It will be carried out across eight locations and will involve more than 460 patients across the world.


Elsevier acquires 3D4Medical

Global information analytics company Elsevier has acquired Irish anatomical education company 3D4Medical for just under €45m.

Although the terms of the agreement have not been officially announced, 3D4Medical’s investor the Malin Corporation has issued a release indicating that its 38% stake in the company had generated net proceeds of €17m, valuing the transaction at €44.7m.

3D4Medical has created Complete Anatomy, a 3D visualisation platform for training students, educators, health professionals and patients in how to understand and interact with anatomy. Complete Anatomy has garnered 1.2 million registered users across more than 300 universities worldwide.


Canadian researchers use blood test to assess pulmonary embolism

Canadian researchers have discovered an approach to interpret blood test results in patients examined for pulmonary embolism (PE), a condition of blood-clotting in the lungs.

The approach applies to D-dimer blood tests used to rule out the presence of a blood clot.

The study, led by Hamilton Health Sciences, found that a higher D-dimer level than average could be considered a negative result if the doctor has evaluated the patient to have a low probability of pulmonary embolism.


Qiagen and DiaSorin secure FDA approval for LIAISON QuantiFERON-TB

Qiagen and DiaSorin have secured approval from the FDA for the commercial launch of LIAISON QuantiFERON-TB Gold Plus (QFT-Plus) test, which enables streamlined laboratory automation for latent tuberculosis screening.

QuantiFERON-TB Plus (QFT-Plus) is a fourth-generation modern gold standard for latent tuberculosis (TB) detection that runs on DiaSorin’s LIAISON platforms.

The approval enables shifting from tuberculin skin tests to modern blood-based QuantiFERON technology.


Fluorescent probe sheds light on glycogen

UK-based Iceni Diagnostics is using fluorescent probe technology to explore the structure and metabolism of glycogen, as part of a wider pan-European project using ‘systems medicine’ to investigate glycogen storage diseases (GSD).

GSDs are rare diseases based on specific enzyme deficiencies involved in the breakdown or synthesis of glycogen. Iceni Diagnostics researcher Gaia Fancellu is looking into the characterisation of the branched polymer in healthy people versus GSD patients as part of the Polymers in the Liver: Metabolism and Regulation (PoLiMeR) consortium.

PoLiMeR is taking a ‘systems medicine’-based perspective, creating a computational model of the glycogen breakdown process. When this model is fed with patient data it will have the potential to provide a personalised diagnosis and treatment strategy for each individual.


EOS imaging to launch new generation imaging system EOSedge

French medical device firm EOS imaging has announced plans to launch its musculoskeletal imaging system, EOSedge, at the RSNA Annual Meeting in Chicago, starting on 1 December.

The company has already received regulatory approvals to launch the product in Europe, Canada and Australia. However, it is yet to be approved by the FDA.

EOSedge combines X-ray detection, low-dose radiation and high image resolution to deliver enhanced musculoskeletal imaging exams.


HealthLytix obtains FDA approval for prostate imaging software

The FDA has granted 510(k) clearance for HealthLytix’s breakthrough prostate imaging software, RSI-MRI+.

The approval leverages an advanced diffusion MRI technique known as Restriction Spectrum Imaging (RSI). It allows clinicians to detect and diagnose prostate cancer at an early stage.

Claimed to be the first FDA-approved imaging software, RSI-MRI+ uses artificial intelligence (AI) and a tissue microstructure model to enhance the visibility of reduced water in the body’s tissue.


Indian stent-maker SMT acquires majority stake in Zarek

Indian medical devices firm Sahajanand Medical Technologies (SMT) has acquired a majority stake in Brazil-based medical devices solution provider Zarek Distribuidora De Produtos Hospitalares for an undisclosed amount.

SMT made the acquisition through its Irish subsidiary.

Established in 2007, Zarek’s product portfolio includes interventional cardiology and endovascular products such as coronary and peripheral stents and drug-eluting balloons.