News > Regulatory
Magstim Announces FDA (510k) Clearance of rTMS (Repetitive Transcranial Magnetic Stimulation) Therapy System
The Magstim Company Ltd, an innovative and award winning Wales-based medical device manufacturer, has received FDA 510(k) clearance to market its Magstim Rapid2 Therapy System for the treatment of drug resistant Major Depressive Disorder (MDD) in the United States. The clearance enables Magstim to significantly increase access to cutting-edge Repetitive Transcranial Magnetic Stimulation (rTMS) technology…
Momentum Bioscience Ltd secures CE marking for the first of its range of innovative diagnostic products
Momentum Bioscience Ltd is pleased to announce that it has CE marked Cognitor® Minus, the first in a range of products for the hospital microbiology laboratory utilising ETGA®. ETGA® is a novel technology for the rapid, universal detection of viable bacteria & fungi. Cognitor® products are designed for the rapid detection/exclusion of infection, assisting clinicians…
The planning and production of our new LifeStories publication is well underway and we need your stories. LifeStories magazine will be dedicated to promoting the increasingly successful Welsh Life science industry sector to a worldwide audience. Take this opportunity to tell your greatest story from the past year whether it is of a new…
UK HealthTech 2014 a success for the sector
The UK HealthTech Conference opened its doors for a third time on 4th December at the St David’s Hotel and Spa, Cardiff. MediWales delivered this popular event and with 250 professionals, clinicians and industry specialists, from around the world. Continued support from Health Research Wales allowed all NHS staff to attend the day for free….
UK HealthTech 2014 is almost here
The UK HealthTech Conference is set to open its doors for a third time on 4th December at the St David’s Hotel and Spa, Cardiff. MediWales is delivering this popular event and with 250 professionals, clinicians and industry specialists, from around the world, already registered attendance is up by 25% on last year’s figures. Continued…
MediWales: ABHI Regulatory and Procurement Seminar
On July 1st, MediWales ran a Regulatory and Procurement Seminar which was hosted by Ortho Clinical Diagnostics, Johnson & Johnson at Pencoed. Attracting over 70 delegates, this event highlighted the new Medical Device Directive and the implications of implementing UDI systems for manufacturers of medical devices as well as its implementation in healthcare…
Expert Advice from Withers & Rogers: Unified patent system
Unified patent system gets go ahead, setting the scene for European filings to soar.
NHS drug decisions questioned
Researchers claim NHS drug decisions ‘are flawed’ By Jane Dreaper Health correspondent, BBC News The formula used by the NHS to recommend which drugs should be funded is “flawed” and should be scrapped, researchers say. The European Commission-funded study tested the assumptions of the system used by NICE (the National Institute for Health and Clinical…
Achieving Compliance to ISO 13485 – Barriers to Success & Overcoming them
As a medical device manufacturer, you are no doubt aware that the primary objective of ISO 13485 is to standardise medical device regulatory requirements for quality management systems. ISO 13485 has become the global standard for those who manufacture medical devices because it provides a proven guideline for maintaining assurance and managing risk.
£100m Welsh Life Sciences Fund manager announced
A tender to run the £100m Welsh Life Sciences Fund has been won by new company Arthurian Life Sciences. Documents lodged with Companies House show that the initial share capital in the business – registered last June – is held by Excalibur Fund Managers, which is chaired by biotechnology serial entrepreneur and investor Sir Chris Evans….