FDA Outlines its Approach to Artificial Intelligence Regulation

By MedTech Intelligence Staff

U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work among multiple departments within the FDA. On March 15, the FDA released “Artificial Intelligence and Medical Products:…

U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work among multiple departments within the FDA. On March 15, the FDA released “Artificial Intelligence and Medical Products:…

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Celegence

Post-Market Surveillance Resource Center

The MTI Post-Market Surveillance Resource Center provides current news and information specific to maintaining medical device post market product quality & compliance. PMS is a critical component in achieving global…

The MTI Post-Market Surveillance Resource Center provides current news and information specific to maintaining medical device post market product quality & compliance. PMS is a critical component in achieving global…

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Artificial Intelligence Graphic

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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Red Blood Cells Illustration

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
Soapbox

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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