FDA-Cleared Nanotechnology developed by Nanovis is planned for use to enhance Medtronic PEEK interbody fusion devices used in ...

On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. "Unfortunately, ...

An April 2024 survey of medical device regulatory professionals illustrates potential regulatory fatigue. See how resource constraints, ever changing global policy, and an underutilization of ...

Quality culture is a cornerstone of any industry, particularly the healthcare industry where patient lives are at stake. The implications of quality culture extend beyond operational efficiency; they ...

Stryker has agreed to sell its US spine implant business to Viscogliosi Brothers with plans to create a newly formed company called VB Spine, LLC. The deal also includes a binding offer for Stryker’s ...

With a new executive order to leave the World Health Organization, the Make America Healthy Again (MAHA) movement is driving new policy and promises for faster time to market for product innovation.

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has signed an agreement to sell its Emergency Care business, to ...

EU MDR/IVDR conformity assessments are long-term projects that require a strong and sustainable partnership with a Notified Body. Manufacturers can significantly influence both the outcome and overall ...

The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers, health care facilities, patients, and caregivers that cybersecurity vulnerabilities in Contec CMS8000 ...

The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent ...

Leveraging awareness communications to grasp the potential opportunity for medical devices designed to monitor health and chronic illnesses offered by the new US administration. It’s redundant to ...