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Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds

Sonio has received Regulatory Class II FDA 510(k) clearance for Sonio Detect, a manufacturer-agnostic software product that uses artificial intelligence (AI) to enhance the quality of fetal exams, and automatically…

Sonio has received Regulatory Class II FDA 510(k) clearance for Sonio Detect, a manufacturer-agnostic software product that uses artificial intelligence (AI) to enhance the quality of fetal exams, and automatically…

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Priyanka Rawal
MEDdesign

The Promise and Potential Pitfalls of AI in Medical Device Design

By Priyanka Rawal

…also help improve communication between patients and healthcare providers. For example, AI-powered chatbots can provide patients with instant access to medical information and advice, freeing up doctors and nurses to…

…also help improve communication between patients and healthcare providers. For example, AI-powered chatbots can provide patients with instant access to medical information and advice, freeing up doctors and nurses to…

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FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization

By MedTech Intelligence Staff

…to advance innovation in medical device sterilization. CDRH has updated its Recognized Consensus Standards database to include the complete recognition of one sterilization standard (ISO 22441:2022) and two Technical Information…

…to advance innovation in medical device sterilization. CDRH has updated its Recognized Consensus Standards database to include the complete recognition of one sterilization standard (ISO 22441:2022) and two Technical Information…

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Mindy Herman and Kristen Bednarczyk
Soapbox

The Expansion of IoMT Technology Requires Stringent Privacy Protections

By Kristen Bednarczyk, Mindy Herman

…at the core of life sciences companies. With transparency comes trust, and with trust comes retention. Companies can demonstrate transparency with patients by providing the details of who their data…

…at the core of life sciences companies. With transparency comes trust, and with trust comes retention. Companies can demonstrate transparency with patients by providing the details of who their data…

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Vishnu Kalra

Partnering to Support Sustainability in the OR

By MedTech Intelligence Staff

…Kalra: There are loads of initiatives related to packaging. For example, there are suppliers that are diverting waste from landfills to develop technologies that turn the waste into new materials….

…Kalra: There are loads of initiatives related to packaging. For example, there are suppliers that are diverting waste from landfills to develop technologies that turn the waste into new materials….

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AdvaMed Warns EPA of Massive Interruption to Patient Care

By MedTech Intelligence Staff

In comments filed with the Environment Protection Agency (EPA), industry association AdvaMed called for continued cooperation between the medical device industry and the EPA as the regulations covering medical device…

In comments filed with the Environment Protection Agency (EPA), industry association AdvaMed called for continued cooperation between the medical device industry and the EPA as the regulations covering medical device…

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Maria Shepherd

Perseverance Is Key

By MedTech Intelligence Staff

…MedTech companies get answers to their strategic questions, which helps them chart the course of their companies. A lot of these question are very difficult for companies: Which device do…

…MedTech companies get answers to their strategic questions, which helps them chart the course of their companies. A lot of these question are very difficult for companies: Which device do…

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Leeanne Baker

Bringing your Medical Device to the UK: What You Need to Know about UKRP

By Leeanne Baker

…and making them readily accessible Immediately informing the manufacturer about complaints and reports from healthcare professionals, patients and other users Appointing a single UKRP to act on their behalf is…

…and making them readily accessible Immediately informing the manufacturer about complaints and reports from healthcare professionals, patients and other users Appointing a single UKRP to act on their behalf is…

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Roy Shuvo, Ph.D.

Device Development: A Hybrid Implantable Kidney

By MedTech Intelligence Staff

…is to grow a new human kidney and the other is to use pig kidneys. We have taken a fundamentally technology-first approach. It is a hybrid approach where you combine…

…is to grow a new human kidney and the other is to use pig kidneys. We have taken a fundamentally technology-first approach. It is a hybrid approach where you combine…

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