Astek Diagnostics Inc. has wound up a successful $2 million early stage VC funding round to support the development and launch of a medical device designed for the speedy recovery of patients suffering from urinary tract infections (UTI). The Baltimore-based startup has designed a benchtop analyzer and disposable cartridge called the Jiddu that can detect bacterial infection in urine in one hour.
The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
Adicon Holdings Ltd. raised HK$409 million (US$52 million) in an initial public offering on the Hong Kong stock market. Its shares opened at HK$12.32, jumped 12% and closed at HK$13.8 on the first trading day. Hangzhou, China-based Adicon is among the top three independent clinical laboratory (ICL) service providers in China by total revenues. It offers testing services to hospitals and health check centres through a network of 33 self-operated laboratories across China.
The U.K. National Institute for Health and Care Excellence (NICE) released several draft and final health technology assessments on July 5, including a review of the use of artificial intelligence (AI) to aid in the detection of lung nodules in CT images. The agency said that more research is needed before it will be able to provide an unqualified endorsement because of a relative lack of data that could be reliably generalized from clinical study subjects to the broader U.K. population at large.
A non-invasive retinal exam may soon enable clinicians to visualize the future for patients at risk of chronic kidney disease (CKD). When combined with an artificial intelligence algorithm, an exam accurately predicted CKD prior to symptom onset in a study published in Digital Medicine.
Rapid point-of-care diagnostics company Lumos Diagnostics Inc. saw its stock shoot up 327% on the news that it finally gained U.S. FDA 510(k) clearance for its Febridx rapid, point-of-care test for bacterial infections. Febridx is a finger prick blood test that can indicate if a person has a bacterial or viral acute respiratory infection within 10 minutes.
Precision diagnostics company Inoviq Ltd.’s stock soared 44% on the news that its breast cancer diagnostic, SubB2M/CA15-3, detected all stages of breast cancer with 87% accuracy, 81% sensitivity and 93% specificity. The clinical validation study that included 483 samples outperformed the standard of care CAS15-3 test, demonstrating an area under the curve (AUC) of .93 compared to .70.
The U.K. government created a new £21 million ($US26.55 million) fund to accelerate the roll out of artificial intelligence (AI) diagnostics and treatment tools across the NHS. The AI Diagnostic Fund will enable hospitals to bid for funding to speed up the deployment of the most promising AI imaging and decision support tools to help patients with cancers, strokes and heart conditions.
The U.S. Office of Inspector General (OIG) has concluded an analysis that found fault with Medicare payments for genetic testing under CPT code 81408, a code that covers tests for a variety of mutations of medical interest. According to OIG, these claims were often paid $2,000 each despite poor oversight from Medicare administrative contractors (MACs), raising the risk that a substantial percentage of roughly $888 million in claims paid between 2018 and 2021 were either fraudulent or at best inappropriate.
The near $50 million cash injection Nvision Imaging Technologies GmbH recently received is “instrumental” as it will allow the company to take its hyperpolarized magnetic resonance imaging (MRI) technology to labs worldwide, CEO Sella Brosh told BioWorld. The German startup’s quantum technology makes MRI imaging up to 100,000 times more precise which will allow for the earlier diagnosis of cancer, better assessment of the risks involved and the ability to assess in a matter of days, whether treatment is working.