In the face of an aging population and the demand for cost-effective solutions, spine surgeons hold the targeted insight necessary to determine which devices will find a warm welcome in the market.
A major health insurers group has penned a letter to a U.S. Senator in criticism of the 510(k) approval pathway.
To be successful in this changing industry, developers must seek to disrupt the standard of care, and supply healthcare providers with tools and resources that will improve their day-to-day experiences.
In a recent press release, the World Health Organization has called for increased disclosure of all medical product clinical data, whether or not the trial was successful.
The agency has identified 34 new areas of interest, showcasing its ambition to become better informed on the device development life cycle.
Participation in transparency efforts can evidence a commitment to patient safety and moving the medical device field forward.
For certain reusable devices, manufacturers will have to submit clinical data showing that the device can be cleaned reliably.
Maintaining the balance between speedy device approval and assurance of patient safety requires experienced insight and clinical trial management solutions that focus on efficiency and transparency.
The report, published in the journal Nature Biotechnology, calls the substance SLIPS (Slippery Liquid-Infused Porous Surfaces).
Although the trial process shows strong signs of continued improvement, choosing the right clinical research partner remains crucial to success.
The U.S. Food and Drug Administration (FDA) has approved Q.Clear, a new development by GE Healthcare that the company claims will improve accuracy and quality in PET/CT imaging
Medical Metrics, Inc. (MMI), a leading provider of imaging core lab services for orthopedic clinical trials, has been selected by five leading orthopedic device manufacturers to support multiple cross-sectional, post-market, FDA surveillance studies of metal-on-metal (MoM) hip implants. MMI will independently evaluate radiographs and MRI to assess long-term outcomes in patients implanted with MoM hips. …