FDA approves first at-home chlamydia and gonorrhoea sample collection in US
Kits delivered to a person’s home helps remove the stigma of going to a sexual health clinic to get samples collected for testing. Image credit: Shutterstock/Polina Raulina. The US Food and Drug Administration (FDA) has approved LetsGetChecked’s at-home testing system for chlamydia and gonorrhoea. The De Novo authorisation by the agency means the device is […]
First Human Clinical Trial Using CRISPR to Lower Cholesterol Levels
This therapeutic approach involves injecting patients with VERVE-101, which inactivates the liver gene PCSK9 that typically contributes to higher levels of low-density lipoprotein. Credit: PhotobyTawat/ Shutterstock. Verve Therapeutics released promising results of the first human clinical trial of a novel gene editing technique known as base editing that can help maintain healthy levels of cholesterol. […]
Cytovale raises $84m in Series C funds to expand sepsis test rollout
The Centers for Disease Control and Prevention (CDC) estimates that 1.7 million US adults develop sepsis each year, with 350,000 dying as a result. Image credit: Shutterstock/Elena_Dig. Cytovale has raised $84m in a Series C funding round to continue the rollout of its sepsis diagnosis test. The round was led by Northwest Venture Partners, with […]
AI radiography research finds better image quality with 50% less radiation
Canon’s AI-Driven deep-learning system has been found to produce images of higher quality while limiting radiation doses in paediatric patients. Credit: Shutterstock/Olga Aniven. A radiograph device using an artificial intelligence (AI) deep-learning neural network has been able to improve image quality in pediatric X-rays as part of a US-based clinical study. A white paper, published […]
Roche launches automated Elecsys hepatitis E immunoassays
Hepatitis E only be diagnosed by detecting specific anti-HEV immunoglobulin M (IgM) antibodies to the virus in a person’s blood. Image Credit: Jonathan Weiss / Shutterstock. Roche has launched the automated Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections in CE mark-accepting countries such as the European Union […]
Foundation Medicine to develop NSCLC companion diagnostics
The companies will develop genomic tests as companion diagnostics for new targeted therapies to treat NSCLC. Credit: eczserapyilmaz/Shutterstock.com. Foundation Medicine has collaborated with Pierre Fabre Laboratories for the development of companion diagnostics for non-small cell lung cancer (NSCLC). The partnership will focus on developing the FoundationOne CDx and FoundationOneLiquid CDx genomic tests as companion diagnostics […]
Zymo Research receives approval for saliva collection kit
The SafeCollect Saliva Collection Kit has been specifically designed for Covid-19 testing. Credit: UvGroup / Shutterstock.com. Zymo Research has received US Food and Drug Administration (FDA) 510(k) clearance for its DNA/RNA Shield SafeCollect Saliva Collection Kit. This kit has received clearance as a Class II medical device intended for microbial nucleic acid storage and stabilisation. […]
Aviation Medical confirm safety and efficacy data on smart bladder control system
The non-invasive medical device does not involve surgery, drugs, or needle-electrodes. Credit: AndreyPopov via Getty Images. Aviation Medical has announced positive results from the multi-centre trial of Vivally, its medical device to treat overactive bladder (OAB) syndrome. The FREEOAB multi-centre study enrolled 96 patients with an OAB. Results showed that there were significant reductions in […]
Ethicon receives CE Mark for haemostatic sealing patch
Johnson & Johnson MedTech company Ethicon has received CE mark approval for its ETHIZIA adjunctive haemostatic sealing patch. Credit: josefkubes / Shutterstock.com. Johnson & Johnson MedTech company Ethicon has obtained CE mark approval for its adjunctive haemostatic sealing patch, ETHIZIA. It was approved as an adjunctive haemostat for disruptive bleeding on internal organs, except neurological […]
Inflammatix concludes infection test system development
TriVerity is intended to be used for patients with suspected acute infection and sepsis in emergency department settings. Credit: Inflammatix. Inflammatix has concluded the technical development for its TriVerity Acute Infection and Sepsis Test System, which comprises the Myrna instrument and the TriVerity cartridge. TriVerity is designed for use in emergency department settings to evaluate […]