Selux Diagnostics Inc. has received breakthrough device designation from the FDA for its Next Generation Phenotyping (NGP) platform for positive blood culture and sterile body fluid samples. The NGP technology is a diagnostic platform designed to help with the delivery of personalized antimicrobial therapies within 24 hours. The Boston-based company is hoping the technology can tackle the global antibiotic resistance crisis. According to the World Health Organization, antimicrobial resistance is one of the top 10 global public health threats facing humanity.

PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.

TORONTO – Health Gauge Inc. (HG) and AI-on-Call Inc. will soon deploy a digital remote patient monitoring solution for early prediction of sepsis at three seniors' facilities located in British Columbia. HG’s smartwatch and AI-driven cloud platform capture an array of vital signs data, including blood pressure, heart and respiratory rates, and will be supported by AI-on-Call software that alerts medical staff to early signs of sepsis and acute illness.

The issue of FDA regulation of lab-developed tests (LDTs) has been percolating for a number of years, but the Verifying Leading-edge IVCT development (VALID) Act of 2021 appears to offer the solution. Several stakeholders, including Jeff Allen, president and CEO of Friends of Cancer Research, are eager to see the reforms come through quickly, given the increasingly vital role that tests such as companion diagnostics play in the care of patients facing potentially deadly diseases.

PERTH, Australia – Atmo Biosciences Ltd. has closed an oversubscribed AU$9.6 million (US$7 million) capital raise that will allow it to further develop its gas-sensing capsule for monitoring the health of the gut and the microbiome. Until now, there has not been a diagnostic test that can measure gases in the gut in vivo.

Clinicians may soon be able to identify wounds likely to have difficulty healing before they deteriorate thanks to the FDA’s 510(k) clearance for Moleculight Inc.’s i:X imaging device for detection of wounds containing high levels of Pseudomonas aeruginosa (PA). The point-of-care i:X visualizes fluorescence, with wounds containing elevated levels of PA glowing cyan.

TORONTO – Zilia Inc. has raised C$4 million (US$3.16 million) in seed financing to push new ocular diagnostic technology to regulatory finish lines in the U.S., Canada and eventually Europe. Zilia co-founder and CEO Patrick Sauvageau said the Zilia Ocular is alone in measuring oxygen saturation in the eye, an important biomarker for eye diseases such as glaucoma, diabetic retinopathy and age-related macular degeneration.

The FDA granted de novo marketing authorization for Paige Prostate, artificial intelligence (AI)-driven software that improves detection of prostate cancer. The clinical study submitted to the FDA demonstrated that using Paige Prostate resulted in a 7% improvement in sensitivity in correctly diagnosing cancer, increasing from 89.5% to 96.8%.

LONDON – A pan European research project is working with manufacturers and clinicians to set measurement standards that will transform magnetic resonance images from 2D and pictorial, to 3D and quantitative, significantly increasing their diagnostic power. The project, led by the U.K. metrology body, the National Physical Laboratory (NPL), aims to introduce consistency and specificity for diagnosing specific conditions, by setting independently verifiable ways of noninvasively measuring lesions and the composition of different tissues and organs.