Neurocast.ai, a digital health company transforming brain health monitoring, has officially registered its passive monitoring ...

Aevice Health announced today that it received FDA 510(k) clearance for its AeviceMD smart wearable stethoscope device.

Japan-based Fujirebio's test, which helps doctors diagnose Alzheimer's disease, is intended for patients with signs of ...

FDA inspections are essential to ensuring the safety and quality of products in the food, pharmaceutical, and medical device industries. One of the experienced professionals in this field is John ...

Regulatory alignment with FDA confirmed, clearing path to pivotal U.S. clinical trial -- 150-page strategic business plan and advanced financial models completed -- Investor outreach launched to fund ...

Orchestra BioMed's AVIM earns FDA breakthrough designation, sparking investor optimism. Click here to read why OBIO stock is ...

Trump's order seeks to ease regulations to compel more U.S. drug manufacturing. He also plans to assess tariffs on drug ...

As part of Elucent's mission to lead innovation in real-time localization and surgical guidance for soft tissue excision in ...

With stringent regulations and limited cleanroom space, scaling medical device production is no easy feat. Learn how a ...

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

The global drug delivery technology market is on a transformative trajectory, projected to soar from USD 52.1 billion in 2025 to an astounding USD 136.7 billion by 2035. This reflects a robust CAGR of ...

WASHINGTON, D.C.—FDA Commissioner Martin Makary, M.D., offered more details into the agency’s recently announced plans to ...