
The company also expects to submit its application for 510(k) clearance for its OneRF Trigeminal Nerve Ablation System in May, sooner than expected.

The company also expects to submit its application for 510(k) clearance for its OneRF Trigeminal Nerve Ablation System in May, sooner than expected.

Swiss-based company’s plant will increase capacity to meet demand for autoinjectors

Between President Trump's tariff plan and sweeping layoffs at the FDA and HSS, the medical device industry is facing an uncertain future.

Under the terms, Boston Scientific will pay about $443 million upfront, plus up to $221 million if regulatory milestones occur.

Report shows industry hitting the $1.3 trillion mark by 2029

Omid Veiseh, PhD, faculty director of the Rice Biotech Launchpad, discusses his organization’s mission to create innovative biotechnology based on patient need.

‘The revolution begins today,’ new HHS Secretary RFK Jr. says.

Merged organizations pledge to advance innovative technologies to improve patient care.

Inovalon’s Safety Management solution now on PointClickCare Marketplace

23andMe filed for bankruptcy on March 23, and announced that the company and its genetic data are up for sale. Here's how to delete your genetic data.

Test is designed for females regardless of symptoms and gives results in about 30 minutes

Imported components account for almost half of US companies’ FDA-approved products

Media report highlights how FDA workloads have increased, and delays for new technology approvals will likely suffer

FDA approves Dawes-Redman CTG analysis for U.S. use, enhancing fetal monitoring

Rohit Harve of PA Consulting talks tariffs and their impact on the medical device industry.

Investment will support the expansion of its FDA-approved therapy designed to improve upper extremity function in chronic ischemic stroke survivors.

Tariffs could play a big role in what you pay for medical devices, and they may disrupt the entire industry

Tariffs could play a big role in what you pay for medical devices, and they may disrupt the entire industry

Tariffs could play a big role in what you pay for medical devices, and they may disrupt the entire industry

Here’s what to know about advanced primary care management — and how to get paid for it.

AdvaMed, the Advanced Medical Technology Association, the trade group for medical device manufacturers, released a list of priorities for Congress. Here are some of the key objectives.

President Trump says it’s necessary to impose extra costs on goods from Canada, Mexico and China. What does that mean for the health care sector? Potentially, a lot.

AdvaMed, Senate Democrats warn of regulatory slowdowns and public health threats following mass layoffs at the FDA.

Triage solution is built on existing AI engine

Autonomous solution doesn’t require dilation in vast majority of cases