United Kingdom 2024
Medical Device Updates
31st July 2024: Tourette’s Therapy Wristband Secures £500k Investment
- A University of Nottingham spinout, Neupulse, developed the device to stimulate the median nerve and control involuntary movements.
- Funding will support regulatory approval in the UK, EU, and US.
- Aims to provide treatment for 2% of children worldwide affected by Tourette’s Syndrome.
24th July 2024: GMDN Receives Funding for Post-Market Surveillance Enhancement
- Investment from Innovate UK to modernise post-market intelligence and improve device safety.
23rd July 2024: InnoScot Health Appoints New Regulatory Specialist
- Will oversee Quality Management Systems (QMS) to support medical device growth in Scotland.
24th July 2024: Tydeman Tube Launches Across the UK
- Developed by Dr. Graham Tydeman in collaboration with NHS Trusts and Rocket Medical Plc.
- Designed to assist during Caesarean Section procedures, with positive feedback from clinicians.
- Available through NHS Supply Chain, with plans for global expansion.
United States 2024
Medical Device Updates
10th July 2024: FDA Town Hall on Alternative Sterilization Methods
- Focused on reducing reliance on ethylene oxide (EtO) sterilization.
- Alternatives include gas chemical sterilants and radiation.
- Next session on 7th August 2024 will feature a live Q&A.
29th July 2024: FDA Approves Blood Test for Colorectal Cancer Detection
- Guardant Health’s Shield Blood Test approved as a primary screening tool.
- Demonstrated 83% sensitivity in detecting colorectal cancer.
- Expected to expand Medicare reimbursement and early detection efforts.
29th July 2024: San Diego Research Team Develops Device to Measure Cervical Nerve Activity
- First non-invasive device to record neural activity in vagus and carotid sinus nerves.
- Could aid sepsis research and early detection of life-threatening conditions.
- Developed by InflammaSense.
