News > Regulatory

06th February 2017

Alesi Surgical pioneering surgical device gains United States FDA approval

Alesi Surgical Limited, the leading innovator of minimally invasive surgery technologies has successfully secured FDA (Food and Drug Administration) approval for its Ultravision™ system.
13th October 2016

Expert advice from THAY Medical: CE marking usable medical devices

It is now mandatory to show some form of evidence of use safety when CE Marking a medical device. Whether it is a mobile application with a clinical claim, an inhaler or ECG machine - when developing the next iteration or leap in technology or clinic
08th August 2016

Investment for The Magstim Company supports growth and expansion

Carmarthenshire-headquartered medical technology developer The Magstim Company has invested in new product development and US expansion after it secured backing from a specialist life sciences, medical and healthcare investor. The company, which makes medical devices used in neuroscience, psychiatry and neurology, secured investment from US firm Telegraph Hill Partners last year. Since then it has developed…

28th July 2016

NHS Wales unites with businesses and universities to move healthcare forward in Wales

MediWales recently delivered the first ever all-Wales NHS collaboration conference, MediWales Connects. The clinically-led event hosted delegates from across the fields of life science, health and care to celebrate research progress and patient-centred working in Wales. The theme of collaboration for clinical progress and innovation illuminated throughout the presentations and paved the way for a…

21st July 2016

United Life Sciences explores the UK life sciences landscape following the EU Referendum outcome: What’s next for UK life sciences?

The UK has voted to leave the European Union (EU). Although this decision has caused political and economic uncertainty for the country, it also presents a new political context with opportunities for a re-energised vision for the UK life sciences sector. United Life Sciences, formed of BIA, Bionow, BioPartner UK, One Nucleus and MediWales, will…

21st July 2016

Geldards: Brexit – Business as usual?

It’s been almost a month now since the UK voted to leave the EU. However, the political turmoil that has followed has meant that we are no further forward in terms of knowing when the UK will give notice to the European Council of its intention to withdraw from the EU, how that will be…

20th July 2016

Expert advice – DTR Medical: Nine things that make perfect single-use Crocodile Forceps

As a leading supplier of sterile single-use surgical instruments, DTR Medical receive a wealth of feedback that we build into our programme of innovation and product quality. One of our largest products is our range of Crocodile Forceps that grow every year as a key part of our success. The demand for high quality Crocodile Forceps…

11th July 2016

Grant Thornton: UK votes to leave the EU – advice and scenario planning

The people of the UK have taken the decision to leave the European Union. What happens next – and the implications for businesses and organisations in the UK – is less clear. It is now up to the UK Government to decide on what economic relationship it would seek to replace our current EU membership. To…

05th July 2016

ABHI: Brexit Update

Given the rapid developments and continued uncertainty following the recent EU referendum, ABHI has circulated an update to shape both the long-term outlook for the medical technology industry and address near-term business needs. The sector was represented at Tuesday 28th June’s business leader round table hosted by Sajid Javid MP, the Secretary of State for Business, Innovation and Skills….

24th June 2016

Orphan Drug Designation granted to Neem Biotech’s lead drug candidate for the treatment of Pseudomonas aeruginosa lung infections in CF patients

Neem Biotech’s lead candidate NX-AS-401 has recently received Orphan Drug Designation from the United States FDA for treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. This is a significant boost for the ongoing development of Neem’s flagship candidate drug substance. The outcome of an application for Orphan Drug Designation from the European Medicine…