UK seizes illegally traded medicines and devices worth over £84m in 15 years
The MHRA’s Criminal Enforcement Unit (CEU) has seized over 25 million illegally traded medicines and devices in the UK. Image Credit: stevecoleimages / Getty Images. The UK Medicines and Healthcare products Regulatory Agency (MHRA) celebrated 15 years since the launch of Operation Pangea by providing UK statistics from the programme. The news of counterfeit Ozempic […]
Ortho Development introduces partial knee replacement system
The BKS Uni Knee System. Credit: Ortho Development Corporation / PRNewswire. US-based Ortho Development has expanded its Balanced Knee implant system product line with the introduction of the BKS Uni partial knee replacement system. The system has been developed to simplify surgical techniques, preserve bone and leverage the Balanced Knee System clinical heritage. Ortho Development […]
FDA grants clearance to Xēnix Medical’s SOLACE system
The SOLACE Sacroiliac Fixation System. Credit: Xēnix Medical / Business Wire. The US Food and Drug Administration (FDA) has granted 510(k) clearance to Xēnix Medical for the marketing of the SOLACE Sacroiliac Fixation System with NANOACTIV technology and compatibility with StealthStationNavigation. Engineered with nano-scale surface features at a nanometer (10-⁹) level, the NANOACTIV micro and […]
Syqe Medical receives Australian approval for SyqeAir Inhaler
SyqeAir metered-dose medicinal cannabis inhaler. Credit: Syqe Medical / PRNewswire. Syqe Medical, along with Novachem, has announced the approval of the SyqeAir Inhaler by the Therapeutic Goods Administration in Australia. Novachem is Syqe Medical’s sponsor and distribution partner in Australia. SyqeAir has also been included in the Australian Register of Therapeutic Goods (ARTG). It is […]
Medical Device Network Excellence Awards 2023: Elios Vision
Elios Vision is a US based medical device company and a Category Award Winner for both Innovation and Research and Development in the 2023 Medical Device Network Excellence Awards as it further developed and promoted ELIOS, its ground-breaking laser technology for the treatment of glaucoma. ELIOS is a minimally invasive system that uses a proprietary […]
Phase I/II trial begins for SpyGlass intraocular drug delivery implant
The platform is designed to be implanted during routine cataract surgery and deliver the drug consistently over three years to maintain the lowering of intraocular pressure. Image credit: Shutterstock/Kitreel. SpyGlass Pharma is initiating Phase I/II clinical trials investigating its drug delivery platform in patients with glaucoma and visually significant cataracts. SpyGlass Pharma’s platform consists of […]
FDA tags Olympus Insufflation recall as Class I
According to a 30 October FDA notice, there have been 21 malfunctions, 10 serious injuries, and one death. Image credit: Shutterstock/JHVEPhoto. The US Food and Drug Administration (FDA) has designated a recall of Olympus’ High Flow Insufflation Units as Class I. A Class I recall indicates that continued use of the device with model number […]
M&A market performance suffered in Q3 2023
The outlook for M&A Q4 2023 remains relatively subdued. Credit: iQoncept via Shutterstock. The third quarter of 2023 saw a slight fall in deal activity after the recovery in the global M&A market in the second quarter. Total deals in Q3 totalled $473bn, a drop of 17% compared to the previous quarter. In terms of […]
Hospital 2040: Will AI regulation safeguard the public, or stifle innovation?
AI is here to stay, with health networks such as the UK’s National Health Service, making regulation an urgent issue. Credit: Shutterstock / Yuri A The rising tide of artificial intelligence (AI) has made healthcare stakeholders across the world nervous about the future, as governments worldwide start ramping up plans for healthcare regulation. Proponents of […]
Further positive results reported from Sebela’s investigational IUD
Sebela Women’s Health has announced further positive data from its Phase III trial of VeraCept. Image credit: Shutterstock / New Africa Sebela Women’s Health has announced it has further positive results in a pivotal Phase III open-label study of the investigational copper, hormone-free intra-uterine device (IUD). The data provides further support for the investigational, next-generation, […]