Wearable Cloud, Medical Device Connectivity

Virtual Event Addresses Telemedicine and Healthcare Outside of the Hospital

By MedTech Intelligence Staff

Telemedicine and virtual care has been forever changed by the pandemic. COVID-19 pushed healthcare practices and technology years ahead, where now participating in remote clinician-patient interactions is a norm. That…

Telemedicine and virtual care has been forever changed by the pandemic. COVID-19 pushed healthcare practices and technology years ahead, where now participating in remote clinician-patient interactions is a norm. That…

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FDA

Risk of False Results with Certain Prenatal Genetic Screening Tests

By MedTech Intelligence Staff

The FDA is warning the public about certain non-invasive prenatal screening (NIPS) tests that could generate results that lead to uninformed decision making. There is a risk of false results…

The FDA is warning the public about certain non-invasive prenatal screening (NIPS) tests that could generate results that lead to uninformed decision making. There is a risk of false results…

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FDA

FDA Issues Cybersecurity Draft Guidance, Wants Devices Designed Securely

By MedTech Intelligence Staff

Learn more about Connected Devices by participating in the MedTech Intelligence Series, Connected Care: Digital Health, Wearables & Connectivity | Telemedicine and Healthcare Outside the Hospital As the use of…

Learn more about Connected Devices by participating in the MedTech Intelligence Series, Connected Care: Digital Health, Wearables & Connectivity | Telemedicine and Healthcare Outside the Hospital As the use of…

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Alert

FDA Issues Urgent Notice to Healthcare Providers Following Endoscope Recall

By MedTech Intelligence Staff

Last week Karl Storz issued an urgent medical device recall notice for specific flexible urological endoscopes, providing a labeling update and advising against certain sterilization methods. The labeling update corrects…

Last week Karl Storz issued an urgent medical device recall notice for specific flexible urological endoscopes, providing a labeling update and advising against certain sterilization methods. The labeling update corrects…

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FDA

FDA Seeks $60 Million in Funding to Improve Access to Safe and Effective Medical Products

By MedTech Intelligence Staff

FDA has announced its budget request as part of the President’s 2023 fiscal year budget. Within the medical product sector, the agency is asking for $60 million to help improve…

FDA has announced its budget request as part of the President’s 2023 fiscal year budget. Within the medical product sector, the agency is asking for $60 million to help improve…

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Etienne Nichols, Greenlight Guru
Soapbox

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols

In case you haven’t heard the news, FDA recently released its proposed rule for the new Quality Management System Regulation (QMSR). What does this mean? The FDA is proposing an…

In case you haven’t heard the news, FDA recently released its proposed rule for the new Quality Management System Regulation (QMSR). What does this mean? The FDA is proposing an…

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Alert

Philips Respironics Recalls Certain Ventilators due to Adhesive Failure

By MedTech Intelligence Staff

Philips Respironics is recalling more than 1500 ventilators that were distributed in the United States due to the use of an expired adhesive that could ultimately cause the product to…

Philips Respironics is recalling more than 1500 ventilators that were distributed in the United States due to the use of an expired adhesive that could ultimately cause the product to…

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Wearable Cloud, Medical Device Connectivity

Survey: Patients Agree Wearable Devices Improve Health Outcomes, but Find Them Hard to Use

By MedTech Intelligence Staff

Register now for the second webinar in the Connected Care: Digital Health, Wearables & Connectivity Series, “User Management & Patient Engagement” | April 12, 2022 at 12 pm ET Wearable…

Register now for the second webinar in the Connected Care: Digital Health, Wearables & Connectivity Series, “User Management & Patient Engagement” | April 12, 2022 at 12 pm ET Wearable…

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FDA

FDA Issues Cybersecurity Alert About Vulnerabilities in Software Components

By MedTech Intelligence Staff

Yesterday the FDA issued an alert to medical device users and manufacturers about a cybersecurity vulnerability in software components that could allow an unauthorized attacker to gain complete system access…

Yesterday the FDA issued an alert to medical device users and manufacturers about a cybersecurity vulnerability in software components that could allow an unauthorized attacker to gain complete system access…

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FDA

FDA’s Final Guidance Pushes Companies to be Recall Ready

By MedTech Intelligence Staff

In an effort to help companies be more recall ready, the FDA has finalized a guidance document that reviews how companies should have proper product coding and keep distribution records…

In an effort to help companies be more recall ready, the FDA has finalized a guidance document that reviews how companies should have proper product coding and keep distribution records…

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