April Medical Device Regulatory Updates

2nd April 2024: NHS England Begins Rollout of Artificial Pancreas

• NHS England is identifying eligible adults and children with Type 1 diabetes for an “artificial pancreas” device.
• The Hybrid Closed Loop System continuously monitors blood glucose and delivers insulin via a pump.
• Approved for rollout by NICE in December 2023.
• Expected to benefit approximately 105,000 people.
• NHS England has published a five-year implementation strategy.

2nd April 2024: Cancer Research UK Funds ‘Hydrogel Lollipop’ for Mouth Cancer Diagnosis

• A project from the University of Birmingham is developing hydrogel-based lollipops to detect mouth cancer.
• The lollipop captures proteins for analysis, identifying cancerous cells.
• Funded with £350,000 over three years.
• Researchers are seeking collaborators for further development.

24th April 2024: NHS-Endorsed Hologram Technology Receives European Grant

• Horizon Europe awarded HoloSurge €8.9 million for its Holocare 3D organ hologram technology.
• Helps surgeons view organs in 3D, improving surgical outcomes.
• Initially developed for liver surgery, trials show a 74% reduction in alignment time.
• Uses Microsoft HoloLens for augmented reality visualization.
• Despite Brexit, the UK is participating in this EU-funded initiative.

15th April 2024: FDA Recalls Abbott Heart Pumps Due to Deaths

• HeartMate II and HeartMate 3 devices recalled after links to 273 injuries and 14 deaths.
• Recall affects nearly 14,000 devices but remains a “correction” rather than removal from the market.
• Failure is caused by biological material buildup, leading to blood flow obstruction.

17th April 2024: FDA Updates CDRH Documents

• The FDA’s Center for Devices and Radiological Health (CDRH) released updated reports on safety and innovation.
• The updates aim to ensure continued access to safe and effective medical devices.

19th April 2024: FDA Announces Next Town Hall on Sterilization

• FDA continues efforts to reduce reliance on ethylene oxide (EtO) sterilization.
• EtO sterilization is widely used but classified as a carcinogen.
• Alternative methods include heat, radiation, hydrogen peroxide, and peracetic acid.
• The FDA is monitoring potential supply chain issues resulting from sterilization changes.

18th April 2024: MDCG Issues Guidance on Safety Reporting Under IVDR

• Manufacturers must report serious adverse events for in vitro diagnostic devices across all member states.
• Most serious events must be reported within two days; others within seven days.
• Allows for initial incomplete reports, with final reports submitted later.

24th April 2024: EU Investigates China’s Medical Device Procurement Practices

• Investigation launched into claims that China is using unfair practices to limit EU medical devices in its market.
• Complaints cite slow certification processes and unclear guidelines.
• If confirmed, China could face restrictions from the €2 trillion European medical device market.

29th April 2024: Virus vs. Bacteria AI Software Receives EU MDR Certification

• Smart Blood Analytics Swiss (SBAS) developed an AI tool to distinguish between viral and bacterial infections.
• Reduces antimicrobial resistance by ensuring accurate treatment decisions.
• The first software of its kind to receive EU MDR certification for infectious disease management.