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The enactment of the 1976 Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic (FD&C) Act first gave the FDA authority to regulate medical devices.

Healthcare professionals reviewing protocols, reflecting the FDA's commitment to safety and collaboration in medical advancements.

As the first quarter earnings season begins, pharmaceutical executives are grappling with multiple sources of market instability, including the looming threat of U.S. tariffs on drugs and significant disruptions within federal health agencies.

A gloved hand holds a syringe filled with yellow liquid, injecting it into a red apple alongside two other syringes containing different...

Teleflex is closing its Maple Grove, Minnesota manufacturing facility by March 2026, resulting in the loss of 101 jobs, as part of a restructuring effort following the company's announcement to split into two public entities.

A Design History File (DHF) is a crucial component of medical device development.

Medical devices must undergo extensive testing before being developed and approved to guarantee patient safety and efficacy.

This article will guide you through developing a risk management plan for medical devices, focusing on risk analysis.

Launching Versius in the U.S. is a top priority for CMR, which claims the system is the second most adopted soft tissue robot globally.

Atrial tachyarrhythmia recurred in 39 patients treated with Boston Scientific’s Farapulse PFA device,.

Lobby groups like AdvaMed and the American Hospital Association have so far failed to get medical devices and critical supplies carved out.

The FDA has 3,500 jobs on the chopping block, which could hinder cybersecurity oversight, Democrats said during a subcommittee hearing.

J&J acquired the IVL device maker Shockwave Medical last year for $13.1 billion, Boston Scientific agreed to buy Bolt Medical in January.

Health secretary Robert F. Kennedy Jr. plans to dramatically reshape the CDC department he leads.

With PFA becoming physicians’ preferred ablation method for treating AFib, Abbott is pushing to catch up with rival systems.

A company spokesperson said Dexcom plans to resolve the agency’s concerns but stated no design changes were made to its glucose sensors.

Viedoc has been accelerating clinical trials since 2003. Today, it's one of the fastest-growing eClinical platforms for modern data...