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AAMI and BSI Partner to Publish Guidance on Artificial Intelligence

Leave a Comment / adaptive systems, AI, bias, data management, Digital Health, IEC, ISO, machine learning, Medical Device, MedTech, Quality/Regulatory, TIR34971 / By

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence     The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices. AAMI Technical Information Report (TIR)34971:2023, Application of ISO 14971 to machine …

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Leveraging AI & ML in MedTech: Purpose-Built Applications

Leave a Comment / AI, algorithms, BLE, crowd sourced data, data classification, Digital Health, IMU, machine learning, MEDdesign, Medical Device, MedTech, Product Design & Development, RC - Device Design & Manufacturing, sensor tiles / By

Leveraging AI & ML in MedTech: Purpose-Built Applications     A Venture Capitalist recently joked that to fund a startup, all one must do is choose a URL that ends in ‘.ai’. Although he was not serious, it was an acknowledgment that companies pursuing AI are getting much attention, and there is a fear of missing …

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Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety

Leave a Comment / artificial inteligence, EU MDR, global requirements, Medical Device, medical device regulation, MedTech, MedTech Economics, notified bodies, Quality/Regulatory, Real world data, Soapbox / By

Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety     A harmonious blend of innovation and patient safety is paramount in today’s ever-evolving medical device regulatory landscape. Furthermore, sustainability of massive regulatory data, updates to the evolving regulations, adherence to country-specific requirements, and adoption of an intelligent yet cost-effective approach to reducing overhead …

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FDA Offers Funding for Adoption of Advanced Manufacturing Technologies

Leave a Comment / advanced manufacturing, AI, digital twins, Industry 4.0, machine learning, Manufacturing Execution, Medical Device, MedTech, Product Design & Development, Quality/Regulatory, RC - PLM for Medical Devices, robotics, virtual reality / By

FDA Offers Funding for Adoption of Advanced Manufacturing Technologies     Medical device manufacturers that are in the process of—or interested in—exploring advanced manufacturing technologies can receive funding from the FDA through the Advanced Manufacturing Clearing House (AMCH). The program, which is being run by the Medical Device Consortium (MDIC) in partnership with the FDA, provides …

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FDA CDRH Portal Now Offers Tracking of Pre-Submissions

Leave a Comment / 510(k), CDRH, de novo, Market Access, Medical Device, MedTech, Quality/Regulatory, submission tracking / By

FDA CDRH Portal Now Offers Tracking of Pre-Submissions     On May 22, the FDA announced that it has updated the CDRH Portal to allow users to track the progress of Pre-Submissions. A submitter must specify the type of Pre-Submission request, which include: written feedback (only) written feedback followed by a meeting The agency noted that the …

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Developing Sustainable Medical Devices

Leave a Comment / device design, engineering, ESG, Manufacturing Execution, Medical Device, MedTech, Product Design & Development, RC - Medical Device Component, recycling, standardization, Sustainability / By

Developing Sustainable Medical Devices     Device Talks Boston in May featured a panel, “Past Due: An Open Discussion about Sustainability,” which highlighted steps companies can take now to create more sustainable medical devices and reduce waste. Ronald Kurz, Sr. Director and General Manager at Canon Virginia, Kathryn Unger, Sr. Manager of Global ESG Communications at …

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Wearable Design Challenge: Stick-to-Skin Adhesion

Leave a Comment / adhesives, device lifetime, Digital Health, MEDdesign, Medical Device, MedTech, Product Design & Development, PSAs, stratum corneum, wearables / By

Wearable Design Challenge: Stick-to-Skin Adhesion     Wearable device engineers are working miracles in wringing more performance out of ever-smaller devices. Advances in sensor technology, batteries, and materials have enabled innovations that were impossible only a few years ago. With these advances, one commonly overlooked layer in the early stages of device development is the stick-to-skin …

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Smart Hospitals: Five Technologies Upgrading the Industry

Leave a Comment / AI, connected devices, cybersecurity, data analytics, diagnosis, Digital Health, Medical Device, MedTech, RC - Medical Device Component, remote patient monitoring / By

Smart Hospitals: Five Technologies Upgrading the Industry     Smart hospitals are working to provide patients with more personalized care and a safer hospital experience through technologies including artificial intelligence (AI), robotics and the Internet of Things (IoT). Following are five ways these hospitals of the future are harnessing the latest technologies. Automated Patient Monitoring Consistent …

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Automating Computer Systems Validation for Your QMS

Leave a Comment / automation, compliance, computer system validation, CSA, Digital Health, Medical Device, MedTech, quality management, Quality/Regulatory, RC - Medical Device Audits, Certification & Verification, Soapbox / By

Automating Computer Systems Validation for Your QMS      Companies must show that their software systems are performing as expected to comply with regulatory requirements. All validation activities and test results must be documented to define both how the software is used and what the user needs to do with it. By using this documentation, we …

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FTC Sues to Block Amgen Acquisition of Horizon Therapeutics

Leave a Comment / acquisitons, Amgen, anti-competition, chronic refractory gout, cross-market bundling, Horizon Therapeutics, Medical Device, MedTech, MedTech Economics, monopolies, PBMs, Quality/Regulatory, thyroid eye disease / By

FTC Sues to Block Amgen Acquisition of Horizon Therapeutics     On May 16, the Federal Trade Commission (FTC) announced that it has filed a lawsuit in federal court to block biopharmaceutical giant Amgen from acquiring Horizon Therapeutics, saying the deal would allow Amgen to leverage its portfolio of blockbuster drugs to entrench the monopoly positions …

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