James Darlucio

Navigating Sterilization Options for Silicone Medical Implants

By James Darlucio

…FDA Established Category A Status. MD+DI. Retrieved from https://www.mddionline.com/sterilization/vaporized-hydrogen-peroxide-sterilization-gets-fda-established-category-a-status. [3] S. Martin, E. Duncan (2013). Sterilisation considerations for implantable sensor systems. Implantable Sensor Systems for Medical Applications. Retrieved from https://www.sciencedirect.com/topics/immunology-and-microbiology/vaporized-hydrogen-peroxide….

…FDA Established Category A Status. MD+DI. Retrieved from https://www.mddionline.com/sterilization/vaporized-hydrogen-peroxide-sterilization-gets-fda-established-category-a-status. [3] S. Martin, E. Duncan (2013). Sterilisation considerations for implantable sensor systems. Implantable Sensor Systems for Medical Applications. Retrieved from https://www.sciencedirect.com/topics/immunology-and-microbiology/vaporized-hydrogen-peroxide….

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Artificial Intelligence Graphic

AI Oversight of Growing Interest to Health Care Executives

By MedTech Intelligence Staff

…the complexity of AI and its intersection with ethical, legal, and compliance rules and policies; a lack of internal expertise to evaluate AI solutions in a clinical environment; a desire…

…the complexity of AI and its intersection with ethical, legal, and compliance rules and policies; a lack of internal expertise to evaluate AI solutions in a clinical environment; a desire…

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Logistics Illustration

Healthcare Providers Call for Universal Platform for Recalls and Other Supply Disruption Alerts

By MedTech Intelligence Staff

…systems compromise efficiency and, most importantly, patient safety.” They say that a universal, centralized communication platform will revolutionize their response to recalls and supply disruptions “by offering a single point…

…systems compromise efficiency and, most importantly, patient safety.” They say that a universal, centralized communication platform will revolutionize their response to recalls and supply disruptions “by offering a single point…

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FDA Logo

FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data

By MedTech Intelligence Staff

…third-party data.” In addition to industry communications, the FDA stated that it is pursuing various actions to identify and confront data integrity violations including through it Bioresearch Monitoring Program.  …

…third-party data.” In addition to industry communications, the FDA stated that it is pursuing various actions to identify and confront data integrity violations including through it Bioresearch Monitoring Program.  …

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Doctor working on computer

Benefits and Risks of CDSS To Prevent Medication Errors and Adverse Drug Events

By MedTech Intelligence Staff

…the effectiveness of medication-related CDSSs. For example, natural language processing could be used to access and extract data routinely stored in unstructured fields, such as reports or free-text notes, providing…

…the effectiveness of medication-related CDSSs. For example, natural language processing could be used to access and extract data routinely stored in unstructured fields, such as reports or free-text notes, providing…

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UK Flag

MHRA Announces New UK Approved Bodies

By MedTech Intelligence Staff

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, LNE-GMED UK and Scarlet NB UK. They join the seven current UK Approved Bodies, increasing…

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, LNE-GMED UK and Scarlet NB UK. They join the seven current UK Approved Bodies, increasing…

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NIST Heart on a Chip

NIST Introduces Heart-on-a-Chip for Cardiovascular Research

By MedTech Intelligence Staff

…Federal Food, Drug, and Cosmetics Act of 1938, which mandated animal testing for every new drug development protocol. While for the past century, the mandate was intended to ensure certain…

…Federal Food, Drug, and Cosmetics Act of 1938, which mandated animal testing for every new drug development protocol. While for the past century, the mandate was intended to ensure certain…

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Randy Horton

FDA-Cleared SaMD by the Numbers

By Randy Horton

…by Company What is the breakdown of SaMD clearances among the 308 unique companies on our list? The majority of companies (73.7%) have just one clearance. Companies with two clearances…

…by Company What is the breakdown of SaMD clearances among the 308 unique companies on our list? The majority of companies (73.7%) have just one clearance. Companies with two clearances…

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Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

By Celegence

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration….

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration….

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