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AI Oversight of Growing Interest to Health Care Executives

By MedTech Intelligence Staff

Artificial intelligence (AI) is drawing greater interest from health systems looking to reduce the burden of documentation on clinicians and add automation to administrative functions, among other potential benefits. Yet,…

Artificial intelligence (AI) is drawing greater interest from health systems looking to reduce the burden of documentation on clinicians and add automation to administrative functions, among other potential benefits. Yet,…

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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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FDA Approves Second Indication for Casgevy Cell-based Gene Therapy

By MedTech Intelligence Staff

On January 16, the FDA approved Casgevy from Vertex, a cell-based gene therapy, for the treatment of patients 12 years of age and older with transfusion-dependent beta-thalassemia (TDT), an inherited…

On January 16, the FDA approved Casgevy from Vertex, a cell-based gene therapy, for the treatment of patients 12 years of age and older with transfusion-dependent beta-thalassemia (TDT), an inherited…

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Call for Abstracts: MTI Regulatory Intelligence and Networking Summit

By MedTech Intelligence Staff

The call for abstracts for the 2024 MTI Regulatory Intelligence and Networking Summit, hosted by Medtech Intelligence, is now open. The Summit, which will be held June 3-5, 2024, Washington,…

The call for abstracts for the 2024 MTI Regulatory Intelligence and Networking Summit, hosted by Medtech Intelligence, is now open. The Summit, which will be held June 3-5, 2024, Washington,…

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FDA Announces New Genetic Metabolic Advisory Committee

By MedTech Intelligence Staff

The FDA is creating a new advisory committee related to potential treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee will advise the agency on products used for…

The FDA is creating a new advisory committee related to potential treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee will advise the agency on products used for…

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Bob Tilling, Kallik
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From TikTok Trends To Counterfeit Drugs: How Better Labeling Systems Can Help

By Bob Tilling

news from traditional news sources, so they may be more susceptible to unregulated content. Behind this content are health and fitness influencers who are all-too-often unqualified and unlicensed, potentially spreading…

news from traditional news sources, so they may be more susceptible to unregulated content. Behind this content are health and fitness influencers who are all-too-often unqualified and unlicensed, potentially spreading…

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Naomi Schwartz

Medcrypt Appoints Former FDA Officer to Vice President of Services

Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical…

Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical…

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FDA Withdraws from Global Harmonization Working Party

By MedTech Intelligence Staff

On November 27, the FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA stated that it…

On November 27, the FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA stated that it…

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FDA Publishes Final Guidance on Assessing Credibility of CM&S in Device Submissions

By MedTech Intelligence Staff

The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to…

The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to…

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FDA Recognizes AAMI SW96 Cybersecurity Guidance Document

By MedTech Intelligence Staff

The FDA has officially extended complete recognition to the Association for the Advancement of Medical Instrumentation (AAMI) guidance document on medical device cybersecurity, ANSI/AAMI SW96. Per the FDA, ANSI/AAMI SW96:2023,…

The FDA has officially extended complete recognition to the Association for the Advancement of Medical Instrumentation (AAMI) guidance document on medical device cybersecurity, ANSI/AAMI SW96. Per the FDA, ANSI/AAMI SW96:2023,…

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