Laurel Wreath

Make Your Medical Device Pitch For Kids! Announces Grant Winners 

By MedTech Intelligence Staff

The Rubitection skin assessment management tool for chronic wounds and Kofimi Technology’s pediatric pulse oximeter device received a combined $50,000 in grant funding as part of the ADPI-led pitch competition….

The Rubitection skin assessment management tool for chronic wounds and Kofimi Technology’s pediatric pulse oximeter device received a combined $50,000 in grant funding as part of the ADPI-led pitch competition….

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Torben Robertson

Optimizing Vehicle Reimbursements in Field Service

By Torben Robertson

…ensure fair compensation for employees but also aid companies in managing costs effectively. By adopting VRPs, businesses can offer a flexible and cost-efficient alternative to maintaining a company-owned fleet, which…

…ensure fair compensation for employees but also aid companies in managing costs effectively. By adopting VRPs, businesses can offer a flexible and cost-efficient alternative to maintaining a company-owned fleet, which…

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Marie Hattar

Designing Wearable Healthcare Devices We Can Trust

By Marie Hattar

…of this new wealth of information relies heavily on a sound, interoperable ecosystem. The ability for different devices and systems to communicate and share data, while complying with standards, is…

…of this new wealth of information relies heavily on a sound, interoperable ecosystem. The ability for different devices and systems to communicate and share data, while complying with standards, is…

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FDA Outlines its Approach to Artificial Intelligence Regulation

By MedTech Intelligence Staff

…systems used in the medical product life cycle, emphasizing continued monitoring and mitigation of risks. Support Research Related to the Evaluation and Monitoring of AI Performance Identify projects that highlight…

…systems used in the medical product life cycle, emphasizing continued monitoring and mitigation of risks. Support Research Related to the Evaluation and Monitoring of AI Performance Identify projects that highlight…

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EPA Logo

EPA Issues Final Rule on Ethylene Oxide Emissions

By MedTech Intelligence Staff

…near commercial sterilization facilities. The EPA estimates that implementation of the new regulations will reduce EtO emissions from commercial sterilization facilities by approximately 21 tons per year (tpy), or more…

…near commercial sterilization facilities. The EPA estimates that implementation of the new regulations will reduce EtO emissions from commercial sterilization facilities by approximately 21 tons per year (tpy), or more…

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Shawn Luke

Bringing MedTech Innovation to Life

By Shawn Luke

new solutions is fueling innovation and digitalization across the industry. New advances in data analytics through artificial intelligence and machine learning are changing the future of the MedTech industry—a market…

new solutions is fueling innovation and digitalization across the industry. New advances in data analytics through artificial intelligence and machine learning are changing the future of the MedTech industry—a market…

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FDA Logo

FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

By MedTech Intelligence Staff

…the FD&C Act Devices Subject to Section 524B of the FD&C Act Documentation Recommendations to Comply with 524B Stakeholders may submit comments under docket number FDA-2021-D-1158 at www.regulations.gov by May…

…the FD&C Act Devices Subject to Section 524B of the FD&C Act Documentation Recommendations to Comply with 524B Stakeholders may submit comments under docket number FDA-2021-D-1158 at www.regulations.gov by May…

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Karim Aly

Breath-based Analysis: Revolutionizing Disease Screening for a Healthier Tomorrow

By Karim Aly

…2024.https://www.lung.org/research/state-of-lung-cancer/key-findings [4] National Cancer Institute. Lung Cancer Screening (PDQ®)–Health Professional Version. Updated June 9, 2023. Accessed February 7, 2024. https://www.cancer.gov/types/lung/hp/lung-screening-pdq [5] Larracy R, Phinyomark A, Scheme E. Infrared cavity ring-down…

…2024.https://www.lung.org/research/state-of-lung-cancer/key-findings [4] National Cancer Institute. Lung Cancer Screening (PDQ®)–Health Professional Version. Updated June 9, 2023. Accessed February 7, 2024. https://www.cancer.gov/types/lung/hp/lung-screening-pdq [5] Larracy R, Phinyomark A, Scheme E. Infrared cavity ring-down…

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Post-market surveillance

Enhancing Post-Market Surveillance: Strengthening Medical Device Regulation in the UK

By Celegence

…and searchable. It outlines processes for data collection, analysis, and interactions with relevant parties. Preventive and Corrective Actions (Regulation 44ZG): Manufacturers must immediately reduce risks or non-conformities that compromise a…

…and searchable. It outlines processes for data collection, analysis, and interactions with relevant parties. Preventive and Corrective Actions (Regulation 44ZG): Manufacturers must immediately reduce risks or non-conformities that compromise a…

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