August Medical Device Regulatory Updates

31st August 2024: New Dry Blood Test for Early Prostate Cancer Detection

• Developed by Aston University, this test analyses dry blood samples for crystal-like structures linked to prostate cancer.
• Provides results in under 15 minutes with up to 90% accuracy.
• May offer a more reliable alternative to the current PSA test, which lacks accuracy.
• Prostate cancer accounts for 10% of cancer-related deaths in men.

29th August 2024: MHRA Consultation on Statutory Fees

• Consultation runs from 29th August to 24th October 2024, with new fees taking effect in April 2025.
• Proposed changes:
  • • Registration fees shifting from £240 per registration to £210 per GMDN code.
    • Introduction of fees for post-market work.
    • Creation of a new regulatory advice meeting service.
    • Removal of 51 outdated fees.

22nd August 2024: Stratus Medical and Edge Medical Expand UK Access to RF Ablation Device

• The NIMBUS RF Multitined Expandable Electrode is a radiofrequency ablation device for chronic pain management.
• Stratus Medical (USA) partnered with Edge Medical (UK distributor) for UK distribution.
• UK launch took place on 30th August, followed by a London Spine Intervention Masterclass.

19th August 2024: J&J, Bard, and Boston Scientific Settle Vaginal Mesh Lawsuit

• Over 100,000 women in the UK received vaginal mesh implants, leading to widespread complications.
• Settlement covers 140 women, though manufacturers deny liability.
• Follows a £50 million compensation payout to affected women in Scotland.

29th August 2024: Maui Imaging Secures $4M US Military Partnership

• Maui Imaging’s ultrasound device for intracranial imaging will be used for traumatic brain injuries.
• Device outperforms traditional ultrasound in emergency triage scenarios.

28th August 2024: New Biomedical Device Uses Ultrasound for Chronic Pain Relief

• Diadem uses ultrasound-based neuromodulation to disrupt pain signals.
• Developed by researchers at the University of Utah, with positive trial results leading to final-phase recruitment.

26th August 2024: Study Finds Almost Half of FDA-Approved AI Devices Lack Real Patient Data

• 43% of AI medical devices approved between 2016-2022 were not tested on real patient data.
• Researchers call for stronger clinical validation requirements.

23rd August 2024: FDA Releases De Novo Final Guidance

• By October 2025, all De Novo pathway submissions must use the eSTAR electronic template.

8th August 2024: FDA Issues Draft Guidance on Predetermined Change Control Plans (PCCPs)

• PCCPs outline planned modifications to medical devices to ensure continued safety and effectiveness.
• Applies to devices under 510(k), De Novo, and PMA pathways.

6th August 2024: Concerns Raised Over Software-Based Medical Device Recalls

• FDA issued Class I recall for Medtronic’s NIM Vital Nerve Monitoring System due to false negative results.
• Previous Medtronic recall involved the StealthStation S8 Application, which caused neurosurgical misalignments.

August 2024: FDA Changes How Guidance Documents Are Searched

• Categories now split into:
• • • Class II Special Controls Documents
    • General Guidance Documents

29th August 2024: Autonomous Blood Drawing Robot Receives CE Mark

• Vitestro’s AI-based ultrasound-guided robot automates blood draws.
• Expected benefits include standardised procedures, faster draws, and improved accuracy, especially for patients with darker skin.
• European market rollout planned within 12 months.

28th August 2024: MRI-Based Body Composition Analysis Device Receives EU MDR Approval

• AMRA Profiler 4, developed by AMRA Medical, helps analyse body composition, liver fat, and muscle mass for clinical decision-making.
• Recently approved by the FDA; now cleared for EU distribution.

13th August 2024: EUDAMED Playground Update

• EUDAMED, the EU’s medical device database, updated to version 3.9.
• Introduces new registration requirements for specific device types, including contact lenses and spectacle frames.

2nd August 2024: EMA Launches Pilot Program for Orphan Medical Devices

• Supports manufacturers developing rare disease devices affecting fewer than 12,000 patients in the EU.
• Provides free expert advice on clinical evaluation requirements.