This month’s Asian Medtech Associations Regulatory Networking discussions is split into two parts, the first being a guest presentation on EU themes, specifically a UK Brexit outlook and an update on the progress of the EU IVDR, which comes into full effect on 26 May 2022. Both have potentially far-reaching effects for Asian and other global medtech markets. Part two will feature AHWP and Asean updates, as usual. This editorial feature is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).
As far as EU medtech regulations are concerned, most of the talk and almost all of the fears surrounding the lack of readiness of both the new system and of its users are coming from medical devices stakeholders. On the surface, the IVD industry seems relatively unflustered; and some of the smaller IVD firms are not even aware of how they will be impacted by it.
The worry for people like Simon Richards, who is the former chair of the British In Vitro Diagnostics Association (BIVDA)...
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
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This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
