Daily Medical Device Industry Updates - Latest

I. Global Regulatory Updates

• FDA｜Releases draft for comment on AI medical device performance evaluation [1]
  2025-10-08
  Focused on model drift, data bias, and performance validation; comments are open through December 1.

• FDA｜Government shutdown affects guidance updates [2]
  2025-10-07
  The FDA has paused acceptance of certain new device submissions requiring user fees, while continuing review of applications already under assessment.

• FDA｜Releases FY 2025 guidance priorities [3]
  2025-10-06
  Key focus areas include cybersecurity, AI PCCP, pulse oximeter revisions, and risk management guidance.

• EU MDR｜MDCG releases FAQ on AI medical device compliance [4]
  2025-10-04
  Clarifies how MDR/IVDR interfaces with the AI Act, with emphasis on clinical evidence and data governance.

• EU HTA｜Registration opens for Joint Clinical Assessment training (to be held on 10/17) [5]
  2025-10-03
  Designed for manufacturers and assessment bodies, covering IT platform operations and submission standards.

• MHRA｜Route B clinical investigation modification pilot officially launched [6]
  2025-10-01
  Effective through March 2026, it is intended to streamline the approval process for substantial modifications.

• PMDA｜Releases recall information for Class II medical devices [7]
  2025-10-08
  Includes safety alerts related to MR imaging components and software updates.

• NMPA｜Seeks comments on draft rules for implementing UDI under specific circumstances [8]
  2025-09-25
  The draft proposes implementation approaches and exemption scenarios for UDI in specific device situations, with comments open through October 26.

II. Industry & Innovation

• Philips｜Launches next-generation smart anesthesia system IntelliSave AX 2.0 [9]
  2025-10-08
  Integrates AI respiratory control and synchronized surgical information, aligned with the latest MDR requirements.

• Siemens Healthineers｜Launches the Artis Icono Pro image-guided system [10]
  2025-10-08
  Improves imaging quality for neurointerventional procedures and has obtained CE marking.

• Medtronic｜Receives FDA approval for the Altaviva™ tibial neuromodulation device [11]
  2025-10-07
  Indicated for urgency urinary incontinence, it offers a new implantable neuromodulation option.

• GE HealthCare｜Launches the Carestation™ 850 anesthesia platform [12]
  2025-10-07
  The new system integrates clinical decision support and real-time monitoring to improve ICU safety.

• Boston Scientific｜Announces Q3 investor meeting and new product unveiling plans [13]
  2025-10-08
  The company will highlight its neuromodulation and electrophysiology businesses.

• TÜV Rheinland｜Publishes the latest list of MDR-certified companies [14]
  2025-10-07
  Six additional Asian companies have obtained MDR Class IIb certification.

III. 🌏 Hot Topics & Trends

• Global UDI implementation enters a new phase [15]
  UDI labelling for EU Class I devices will be fully implemented by December 31, 2025, and the FDA has completed integration of NDC and UDI.

• International consensus is taking shape on AI regulation for medical devices [16]
  IMDRF has released the draft AI Software as a Medical Device Terminology Guide v3, clarifying the classification of algorithm changes.

• China opens applications for the "High-end Medical Equipment Innovation Program" [17]
  The Ministry of Industry and Information Technology, together with the National Health Commission, has issued the 2025 call for submissions for the key support list for high-end medical equipment.

Reference

1. https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates

2. https://www.fda.gov/news-events/fda-newsroom

3. https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products

4. https://health.ec.europa.eu/medical-devices-sector_en

5. https://health.ec.europa.eu/medicines/hta_en

6. https://www.gov.uk/government/collections/mhra-guidance-on-medical-devices

7. https://www.pmda.go.jp/english/

8. https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjylqx/20250925145905186.html

9. https://www.philips.com/news

10. https://www.siemens-healthineers.com/press-room

11. https://news.medtronic.com/

12. https://www.gehealthcare.com/

13. https://news.bostonscientific.com/

14. https://www.tuv.com/world/en/newsroom/

15. https://udi.fda.gov/

16. https://www.imdrf.org/

17. https://www.miit.gov.cn/