Telix seeks prostate cancer imaging kit approval from FDA
The kit will be used for the preparation of PSMA-PET imaging for prostate cancer diagnosis and management. Credit: Jo Panuwat D/Shutterstock.com. Australian company Telix Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TLX007-CDx, a new prostate cancer imaging kit. This kit will be used for the […]
Medical Device Network Excellence Awards 2024: B. Braun
Germany-based medical technology company B. Braun has won two awards in the 2024 Medical Device Excellence Awards, in the Product Launches and Safety categories, for launching the Introcan Safety® 2 IV Catheter, which is a significant advancement in vascular access devices. The comprehensive safety features of Introcan Safety® 2, coupled with its efficiency-enhancing design, have […]
FDA approves new tool to enhance cataract surgery outcomes
The tool includes questions on 15 symptoms, overall vision perceptions, and the need for additional visual aids after surgery. Credit: BLACKDAY/Shutterstock.com. The US Food and Drug Administration (FDA) has qualified the American Academy of Ophthalmology’s patient-reported outcome measure for Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) as a Medical Device Development Tool (MDDT). This qualification […]
FDA tags Vyaire’s twin tube recall as Class I
This is the second Class I recall of the year for Vyaire. Image credit: Shutterstock/Tada Images. Vyaire Medical has already had a US Food and Drug Administration (FDA)-tagged Class I recall this year, and now the company is in hot water with the agency again – this time for tubes in the company’s cardiopulmonary exercise […]
Medical manufacturers begin to reshore, with positive impacts
Since 2020, global supply chains have faced significant disruptions due to factors such as geopolitical conflicts, armed conflicts, climate change and shifting demographics. These challenges have been particularly acute in the medical devices sector, where maintaining resilient supply chains is critical. The Covid-19 pandemic starkly highlighted the vulnerabilities in the sector, leading to severe shortages […]
Ireland – the jewel in the life sciences crown?
Image credit: Shutterstock/hyotographics Foreign direct investment (FDI) has been a cornerstone of Irish economic policy since the country’s investment agency IDA Ireland launched in 1949, but Ireland’s ties with the life science industry seem to be going from strength to strength. According to IDA Ireland, over 300 medtech companies are now operating in the country […]
Medical device companies warned that ignoring climate change could spell disaster
The medical device industry’s impact on the global climate took centre stage at a Vienna conference centre on 24 may. Credit: Shutterstock / Vereshchagin Dmitry The medical device industry is being urged to prepare for the impact of a climate crisis as hotter summers and more adverse weather events threaten to impact the industry with […]
Seastar touts positive case studies for selective cytopheretic device
Seastar’s selective cytopheretic device (SCD) has improved the clinical status of four critically ill paediatric and adult patients across multiple clinical conditions. Credit: Irin Somsuppamongkol via Getty Images. Seastar has released positive case studies showing that its selective cytopheretic device (SCD) improved the clinical status of four critically ill paediatric and adult patients across multiple […]
MediThinQ launches new micro surgery solution
The MediThinQ’s SCOPEYE 3D Micro Surgery Solution. Credit: PRNewswire/ VentureBlick/ MediThinQ. Korean startup MediThinQ has announced the launch of its SCOPEYE 3D Micro Surgery Solution, which uses the latest Eyes Up Display technology for improving precision across medical specialties. The solution includes the SCOPEYE Eyes Up wearable display, the light and portable 3D digital microscope […]
Heuron’s AI solution for stroke triage receives FDA clearance
The AI solution can automatically detect potential intracranial haemorrhage cases. Credit: MUNGKHOOD STUDIO/Shutterstock.com. South Korean medical AI startup Heuron has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Heuron ICH solution, a non-contrast CT imaging analysis tool for intracranial haemorrhage. This approval marks the first for a Korean AI-based brain […]