This explains the end-to-end regulatory framework governing medical device imports into India. It highlights why compliance with CDSCO, DGFT, BIS, Customs, and GST laws is essential for smooth ...

Questions about cost and patient benefit loom as Congress considers automatic Medicare coverage for 'breakthrough' medical ...

The Centre warned that this would turn a freely available product into a tightly regulated one, raise compliance burdens and ...

SPE/MPD MiniTec conference at MD&M West features medical polymer innovations, sustainability keynote, and device design ...

According to U.S. Centers for Medicare and Medicaid Services (CMS), as of 2023, the amount of money the average American spends on healthcare was $14,570 per person. That figure alone could be ...

Abstract: This paper presents a comprehensive review of recent advancements in 3D medical imaging utilizing artificial intelligence (AI) techniques. The review encompasses various studies focused on ...

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The Food and Drug Administration rarely uses its authority to ...

Inspire Medical Systems, Inc. (INSP) Securities Class Action: The complaint, captioned City of Pontiac Reestablished General Employees' Retirement System v. Inspire Medical Systems, Inc., No.

An Upper Saucon Township company that specializes in surgical equipment will pay $38.5 million to settle allegations under the False Claims Act, U.S. Attorney David Metcalf and the Justice Department ...