A comparison of eight AI-powered requirements management platforms for 2026, from NLP-based quality analysis and automated test generation to live traceability scoring, covering Jama Connect, IBM ...

The FDA’s draft MDUFA VI agreement proposes new, faster pre-submission track, changes to de novo communication and more.

EU AI Act enforcement 2026 is now fully active: the Digital Omnibus on AI entered into force this week, making the high-risk ...

The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical ...

The EPA tried to make it harder for hospitals to obtain essential sterilized medical equipment. Two years later, the EPA is ...

A unified governance approach can satisfy all three regulatory streams more efficiently than three separate compliance tracks ...

India has proposed major changes to ambulance standards, including neonatal and multi-stretcher ambulances, mandatory rescue ...

In a key commercial milestone, Optiscan Imaging has brought its first clinical device to market with the US launch of ...

Unlike many recent advisory opinions in which the OIG acknowledged AKS implications but nevertheless exercised enforcement ...

Implantable brain devices—from deep brain stimulation to a new generation of brain-computer interfaces—can help people with severe, treatment-resistant psychiatric and neurological conditions or loss ...

On June 29, the Council of the European Union (EU) formally adopted the amendments to the EU AI Act as part of the Digital ...

Revenue Increased 10%; Gross Margin Expanded to 57%; Operating Income Increased 86%; Net Income Increased 67% Anticipating Continued Revenue Growth in 1H 2027 Driven by Strong Medical Sector and Highe ...