USA – TCET pathway may broaden access to breakthrough devices, but reforms still needed
While the Transitional Coverage for Emerging Technologies (TCET) pathway proposed by the Centers for Medicare and Medicaid Services (CMS) offers the potential to speed...
USA – Existing software development lifecycle tools can help speed AI/ML products to market
Software developers creating artificial intelligence/machine learning (AI/ML) medical products should move forward with the software development lifecycle (SDLC) models they are already familiar with...
USA – Providing context to AI/ML products may address explainability says FDA
Context is important when trying to address issues of transparency and explainability of artificial intelligence and machine learning products (AI/ML), according to a regulatory...
USA – Legacy devices report highlights need for data to support future policies
More data is needed to understand the risks legacy connected medical devices pose to the healthcare system, particularly in their vulnerability to cyberattack. That...
USA – FDA publishes final guidances on device shortage reporting, computational modeling
The US Food and Drug Administration (FDA) has published two final guidance documents for medical devices on the agency’s implementation of Section 506J of...
USA – Stakeholders not working together to develop AI standards, expert laments
Collective intelligence is necessary for the creation of standards for artificial intelligence.
That was the message Pat Baird, senior regulatory specialist at Philips brought to...
Europe – Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
USA – Medtech expert says EU’s AI Act could face an uphill political battle
If the EU is unable to pass a hotly anticipated artificial intelligence/machine learning (AI/ML) law by year’s end, it may face an uphill battle...
USA – Experts call for data transparency with recalled medical devices
Over the last few years, some patients have been receiving implantable cardioverter-defibrillators (ICDs) that are subject to Class I recalls. These devices have continued...
USA – FDA highlights updated labeling for some surgical mesh products, cautions against use...
The US Food and Drug Administration (FDA) issued a letter to healthcare providers to make sure they are aware of updated warnings and precautions...
