CORTLAND, NY / ACCESS Newswire / January 22, 2025 / Cortland Biomedical , a full-service biomedical textile product ...

De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low ...

Medtech supplier Cortland Biomedical said the new designation positions it as a full-service contract manufacturer.

Mylan has agreed to pay $73.5 million to settle a class action lawsuit by drug wholesalers accusing the drugmaker of scheming ...

The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device ...

The FDA is elevating a recall from Philips related to one of its wearable outpatient heart monitors, used to help detect ...

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support ...

I am pleased with the growth and accomplishments related to the Company’s key strategic objectives to set a new standard in neurovascular access and delivery,” said Brian Martin, co-founder and CEO of ...

Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.

FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...

The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...