LUMA raises $22m to secure FDA clearance for 4D cardiac imaging
LUMA’s Verafeye is a 4D cardiac imaging and navigation platform that provides real-time guidance during cardiac surgery. Image Credit: Yurchanka Siarhei / Shutterstock. LUMA Vision has raised $22m in Series A3 financing to fund the FDA clearance and commercialisation of Verafeye in the country. The financiers included EQT Lifesciences, ABV Uni Fund, imec.xpand, Atlantic Bridge […]
How COP28 raised the profile of ‘super pollutants’ like black carbon
Attendees inside pollution pods, geodesic domes simulating air pollution levels in Beijing, London and New Delhi, at the COP28 climate conference at Expo City in Dubai, United Arab Emirates, 1 December, 2023. Credit: Annie Sakkab/Bloomberg via Getty Images. DUBAI – Nestled between the hundreds of pavilions in COP28’s sprawling Blue Zone were four geodesic domes. […]
GRIP and MTL partner for electronic biosensor technology study
GRIP’s disposable diagnostic cartridge utilises samples collected by the user. Credit: Tatiana from Pixabay. GRIP Molecular Technologies and Molecular Testing Labs (MTL) have announced a collaboration, which involved a successful clinical feasibility study of an advanced electronic biosensor technology. The aim is to deliver lab-quality, multi-disease diagnostic test results directly to consumers within minutes. The […]
Why COP28 was the first COP to truly align with climate science
Activists stage a protest on the last day of COP28 in Dubai. Credit: Fadel Dawod via Getty Images. At the closing plenary of COP28 in Dubai, most parties gave their expected takes on the final cover text. The representative for the Marshall Islands – a small island state for whom a temperature rise of more […]
Anagenex and Nimbus team up for small molecule drug discovery
The Anagenex platform will be used to identify drug candidates that are selective and potent. Credit: gorodenkoff via Getty Images. US-based Anagenex and Nimbus Therapeutics are partnering to jointly discover small molecule drugs, utilising Anagenex’s artificial intelligence (AI) biochemistry platform. Anagenex will employ its platform to generate vast amounts of experimentally measured data for […]
Regulatory changes in the US and UK to watch in 2024
Significant regulatory changes across numerous medical fields are coming in 2024. credit: Shutterstock / tete_escape Significant regulatory changes across numerous medical fields are coming in 2024 with pharmaceutical and medical device companies urged to be ready for a year of legal alterations. From the UK’s reworking of the Voluntary Scheme for Branded Medicines (VPAS) and […]
Biomerica swings 501(k) clearance for H. pylori bacteria diagnostic test
The bacteria has previously been identified as present in 80% of gastric cancers, the third most common cause of cancer-related death worldwide. Credit: Shutterstock /MohamadOuaidat US-based firm Biomerica has announced that it has received US Food and Drug Administration (FDA) 501(k) clearance to market its diagnostic device for the detection of H. pylori bacterial infections. […]
EQT to acquire fluoropolymer tubing solutions provider Zeus
Zeus is engaged in the design, development, and extrusion of fluoropolymer tubing for medical devices. Credit: EQT AB 2022. EQT AB (PUBL). The EQT X fund has signed an agreement to acquire Zeus, a provider of fluoropolymer tubing for medical devices, from the Tourville family, for an undisclosed sum. Established in 1966, Zeus is involved in […]
Align receives clearance for 3D printed orthodontic device
The approval is for a wide range of patients, including teenagers, growing children and adults. Credit: Jacob Lund/Shutterstock.com. Align Technology has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its direct 3D-printed device, Invisalign Palatal Expander System, designed to address skeletal and dental expansion in growing patients. The approval is for […]
Masimo’s baby monitoring system receives US FDA clearance
The Masimo Stork baby monitoring system is offered as a non-medical device for general health and wellness purposes at retailers nationwide. Credit: Masimo / Business Wire. Masimo has received the US Food and Drug Administration (FDA) clearance for its baby monitoring system, Stork. The system is intended for prescription use with sick and healthy babies […]