FDA Outlines its Approach to Artificial Intelligence Regulation

By MedTech Intelligence Staff

…and addresses safety and cybersecurity concerns). Identify and promote best practices for long-term safety and real-world performance monitoring of AI-enabled medical products. Explore best practices for documenting and ensuring that…

…and addresses safety and cybersecurity concerns). Identify and promote best practices for long-term safety and real-world performance monitoring of AI-enabled medical products. Explore best practices for documenting and ensuring that…

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EPA Logo

EPA Issues Final Rule on Ethylene Oxide Emissions

By MedTech Intelligence Staff

…ensure risk reductions for surrounding communities. The final rule will address emissions at nearly 90 commercial sterilization facilities that are owned and operated by approximately 50 companies and includes finalizing…

…ensure risk reductions for surrounding communities. The final rule will address emissions at nearly 90 commercial sterilization facilities that are owned and operated by approximately 50 companies and includes finalizing…

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Shawn Luke

Bringing MedTech Innovation to Life

By Shawn Luke

…professionals, patients, families, and others. Wearables and Personalized Treatment Creating and launching a new medical device is no easy feat, and overcoming stress testing of individual components and filing for

…professionals, patients, families, and others. Wearables and Personalized Treatment Creating and launching a new medical device is no easy feat, and overcoming stress testing of individual components and filing for

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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FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations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

…expensive, invasive tests that are frequently inaccessible to patients. Compounding the issue, certain diseases with non-trivial morbidity and mortality rates lack a universally accepted screening protocol. However, breath-based screening tests…

…expensive, invasive tests that are frequently inaccessible to patients. Compounding the issue, certain diseases with non-trivial morbidity and mortality rates lack a universally accepted screening protocol. However, breath-based screening tests…

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Post-market surveillance

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

By Celegence

…effectively and embrace a proactive approach to compliance while contributing to maintaining a trustworthy and responsible presence in the medical device market. Reference: https://members.wto.org/crnattachments/2023/TBT/GBR/23_11298_00_e.pdf https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1154632/   MedTech Intelligence Content…

…effectively and embrace a proactive approach to compliance while contributing to maintaining a trustworthy and responsible presence in the medical device market. Reference: https://members.wto.org/crnattachments/2023/TBT/GBR/23_11298_00_e.pdf https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1154632/   MedTech Intelligence Content…

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Hologic Genius Digital Diagnostics System

Hologic AI-Based Genius Diagnostics System Enters U.S. Market

By MedTech Intelligence Staff

…more than 30 years ago with the development of the ThinPrep liquid-based pap test. “The pap test was one of the best cancer screening tests for decades, but the technology…

…more than 30 years ago with the development of the ThinPrep liquid-based pap test. “The pap test was one of the best cancer screening tests for decades, but the technology…

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Sanobar Syed

Overcoming Forecasting Challenges in Cell and Gene Therapies

By Sanobar Syed

…has evolved to meet the demands of a dynamic landscape, especially with the rise of competition and significant M&As, which have added layers of complexity, particularly in the realm of…

…has evolved to meet the demands of a dynamic landscape, especially with the rise of competition and significant M&As, which have added layers of complexity, particularly in the realm of…

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MedAccred Program Makes Qualified Manufacturers List Publicly Available

By MedTech Intelligence Staff

…by visiting and registering on the EAN platform at www.eauditnet.com. The list includes companies accredited to the following critical processes: Cable and Wire Harness Heat Treating Plastics Extrusion Plastics Injection…

…by visiting and registering on the EAN platform at www.eauditnet.com. The list includes companies accredited to the following critical processes: Cable and Wire Harness Heat Treating Plastics Extrusion Plastics Injection…

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