The FDA has expressed disagreement with criticisms of its draft guidance on the 510(k) Third Party Review Program that suggest it creates patient safety risks and increases the burden on patients and physicians. The agency said the guidance specifies how it will ensure that only appropriate devices are eligible for the program, and that the burden is on the third party to provide a review that is equivalent to the agency's review.
Medicare open enrollment begins today and ends on Dec. 7, and over 60 million seniors are expected to switch plans or stay with their existing coverage. Seniors are increasingly opting for Medicare Advantage plans, many of which offer new supplemental benefits such as transportation assistance, home meal delivery and home improvements.
Reckitt Benckiser turned Newport, R.I., into "OmegaTown" and tested residents for their omega-3 levels. Many were surprised that their levels were not adequate, according to the supplement maker, which used the event to promote its MegaRed omega-3 supplement.
AdvaMed has launched the Center for Digital Health, an "advocacy platform" to advance the development and delivery of technology- and data-driven health care solutions. It will allow member companies to collaborate on addressing the problems and opportunities in digital health and to advocate for public policy changes.
Abbott's FreeStyle Libre continuous glucose monitoring system will be integrated with Omada Health's coaching and chronic disease management platform in a deal recently signed by the two firms.
Xenikos' T-Guard treatment, indicated for patients who experience steroid-refractory acute graft-versus-host disease after undergoing hematopoietic stem cell transplantation, was granted Fast Track designation by the FDA. Xenikos plans to launch a late-stage trial for T-Guard for steroid-refractory acute GVHD post-allogeneic stem cell transplant.
The FDA approved on Friday the use of biotech cotton for human consumption that will allow food manufacturers to develop edible cottonseed that taste similar to chickpeas. The biotech cottonseeds were developed by Texas A&M University scientists and could be commercially available in five years.
The FDA has cleared DiaMedica Therapeutics' request to move forward with its midstage clinical trial to evaluate the safety and efficacy of its investigational drug DM199 as a treatment for patients with chronic kidney disease in two patient groups with the intent of enrolling 60 participants. The two patient cohorts will consist of African American patients with hypertension and CKD and those whose CKD was caused by IgA nephropathy.
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