All articles by Staff Writer

Staff Writer

Yodaplus: Shaping the Future of Industries with Powerful AI Integration

Leveraging artificial intelligence, Mumbai-based IT services firm Yodaplus is catalyzing industry transformations, from nutraceuticals to retail, by streamlining business operations and boosting decision-making capabilities.

FDA Clears CorNeat EverPatch, World’s First Non-degradable, Synthetic Tissue Substitute for Ophthalmic Surgery

CorNeat Vision’s EverPatch Utilizes EverMatrix™, A Novel Material Technology Able to Integrate with Surrounding Tissue

FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test.

An over-the-counter RT-PCR system to detect infectious diseases

The Covid-19 pandemic made clear the global need for rapid, accurate and accessible at-home testing. CO-Diagnostics (Co-Dx) presents its PCR platform, Co-Dx PCR Home, to allow for easy and non-invasive diagnosis at home or in clinics.

Rapid and reliable testing for viral diseases

Accurate, robust and easy-to-use molecular testing of viral meningitis/encephalitis is essential for optimal patient management. To address this challenge, Uniogen has launched a new automated PCR test.

Intelligent automation solutions for IFA

New automation systems for indirect immunofluorescence from EUROIMMUN aid workflow optimisation and analysis standardisation. The UNIQO 160 is designed for complete walkaway automation of IFA, while the EUROLabPolaris software enables digital connection of laboratory sites for centralised evaluation of IFA results. Both products are now CE-marked.

Meridian Bioscience Continues Expansion of H. pylori Diagnostic Testing Solutions with FDA Clearance of Premier HpSA Flex

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) has cleared Premier® HpSA® FLEX™ for the diagnosis of H. pylori in both preserved and unpreserved stools. Premier HpSA Flex joins the extensive Meridian H. pylori portfolio of products that includes BreathID® (urea breath test for H. pylori), Curian® HpSA (fluorescent immuno analyzer antigen test), and ImmunoCard® Stat! HpSA (rapid colorimetric antigen test).

Launch of the FlexStar® CT & NG PCR Detection Mix 1.5 (RUO)

altona has recently launched the FlexStar® CT & NG PCR Detection Mix 1.5 (RUO), our first product of the STI (sexually transmitted infection) panel.

Launch of new cardiovascular disease guidelines

The Albanese Government has today launched the first major update to the cardiovascular disease prevention guidelines in over a decade, in a move that the Heart Foundation estimates could impact the care of 8 million Australians.

Stemline therapeutics, a subsidiary of menarini group, receives u.s. Fda approval for orserdu™ (elacestrant) as the first and only treatment specifically indicated for patients with esr1 mutations in er+, her2- advanced or metastatic breast cancer

ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers.
ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been difficult to treat.
ORSERDU is the first endocrine innovation in more than 20 years, specifically addressing ESR1 mutations, a major unmet need.