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

…this evolution is the involvement of wearable sensors, edge computing, and wireless devices to create seamless connection points useful for the entire medical ecosystem of doctors, nurses, engineers, designers, sourcing…

…this evolution is the involvement of wearable sensors, edge computing, and wireless devices to create seamless connection points useful for the entire medical ecosystem of doctors, nurses, engineers, designers, sourcing…

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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FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations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

…distinct mix of volatile organic compounds (VOCs). This combination of VOCs represents a distinct “scentprint” indicative of the disease and is detectable in breath samples. Targeting these breath scentprints allows…

…distinct mix of volatile organic compounds (VOCs). This combination of VOCs represents a distinct “scentprint” indicative of the disease and is detectable in breath samples. Targeting these breath scentprints allows…

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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

…years ago, the amount of work and the complexity of what we do has grown astronomically,” he said. “That’s where AI can come in and be a valuable tool. There’s…

…years ago, the amount of work and the complexity of what we do has grown astronomically,” he said. “That’s where AI can come in and be a valuable tool. There’s…

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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 Logo

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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Cardio Diagnostics Holdings logo

USPTO Issues Patent for Risk Detection of Cardiovascular Disease Ā Ā 

By MedTech Intelligence Staff

The U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance to University of Iowa Research Foundation (UIRF) for U.S. Application No. 17,857,723 titled “Compositions and Methods for…

The U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance to University of Iowa Research Foundation (UIRF) for U.S. Application No. 17,857,723 titled “Compositions and Methods for…

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