AI vs. Human Judgment: Spectral AI’s DeepView® System Proves Superior in Burn Care
A new AI-driven technology is set to revolutionize burn care! Spectral AI, a company specializing in advanced wound diagnostics, has reported outstanding results from its latest study on the DeepView® System. This innovative system demonstrated 86.6% accuracy in assessing burn wounds—far surpassing traditional clinical judgment (40.8%). By identifying nonhealing tissue with greater precision, DeepView® could lead to faster, more effective treatment decisions. Spectral AI aims to seek FDA approval by mid-2025, with potential availability in early 2026. This marks a major step toward AI-powered advancements in medical care!
ISO 15223-1 Amendment: Say Goodbye to Region-Specific EC Rep Symbols!
Big news for medical device labelling! The latest amendment, ISO 15223-1:2021/Amd 1:2025, now officially defines the European Authorized Representative (EC Rep) and updates its symbol. Previously, the symbol featured EUspecific elements, but the revised version removes country or region-specific references, making it globally applicable. This update simplifies labelling, ensuring greater clarity and consistency for manufacturers worldwide
ISO 15223-1:2021/Amd 1:2025
Why does this matter? A standardized symbol means easier recognition across markets and better regulatory alignment. Medical device companies must update their labels to remain compliant with the latest standards.
Australia Revamps Medical Device Recall Procedures
Australia’s Therapeutic Goods Administration (TGA) has introduced updated recall procedures that comes into effect in March 2025. The new Procedure for Recalls, Product Alerts, and Product Corrections (PRAC) replaces the Uniform Recall Procedure for Therapeutic Goods (URPTG). The PRAC simplifies the recall process by reducing the number of categories from eight to four and streamlining the steps involved. It brings in clearer terminology, enhances transparency, and aims to reduce regulatory burdens. The changes are intended to improve recall timeliness and efficiency, safeguarding public health by addressing unsafe products more effectively.
Australia’s Streamlined Process for Non-Compliant Medical Devices
The Therapeutic Goods Administration (TGA) has updated the process for applying for consent to import, supply, or export medical devices that do not meet the Essential Principles. This application process has shifted from a paper form to an online system, hosted on the TGA Business Services portal. Sponsors can view current and past applications through the portal. While medical devices must typically comply with Essential Principles, the TGA can grant consent for devices that do not meet these requirements, under specific conditions and for a limited time. The online form simplifies the process, improving efficiency and transparency for sponsors.
New Standard Update: Strengthening Biological Safety & Risk Management in Medical Devices
The revised standard emphasizes biological safety within a risk management process, with a reorganized structure and expanded scope. New terms related to biological risk assessment, hazardous situations, and material characterization have been added. Reasonably foreseeable misuse is now considered, and a biological evaluation plan is required. Exposure duration assessments now include intermittent contact and Annex A has been integrated into the main standard.
Key updates include four defined contact types (skin, mucosal membrane, compromised surfaces, blood) and absorption considerations for topical products. Genotoxicity testing is now required for prolonged-contact devices (except intact skin), while carcinogenicity is added for long-term mucosal contact. Neurotoxicity and particulates/toxicokinetics are now part of risk assessment.
A new animal welfare section highlights ethical considerations. Overall, these changes enhance risk-based biological evaluation, aligning with regulatory expectations and improving clarity on material safety and exposure risks
FDA Updates Recognized Consensus Standards for Medical Device Submissions
The FDA has released “Recognition List Number: 063,” detailing updates to its roster of recognized consensus standards for medical devices. These updates include additions, withdrawals, corrections, and revisions across various medical device categories. Manufacturers are encouraged to review these changes to ensure compliance in their premarket submissions. The complete list is accessible in the FDA’s searchable database.
CDSCO Introduces Mandatory CRO Registration and Seamless Integration on SUGAM Portal
The Central Drugs Standard Control Organisation (CDSCO) has initiated an online registration process for Clinical Research Organizations (CROs) via the SUGAM portal, in line with the Ministry of Health and Family Welfare’s directive mandating CRO registration effective April 1, 2025.
CROs and Ethics Committees involved in Drugs, Biologicals, and Medical Devices are required to register on the portal. The system enables seamless navigation, automatically fetching interconnected entity details for applications filed by manufacturers and sponsors. More details and the document checklist are available at CDSCO Online.
