Before President Barack Obama’s 2009 Executive Order that reversed the ethics-driven ban on U.S. Federal funding for human embryonic stem cell research, the European Union had a clear advantage in stem cell research. However, now that the way is clear in the United States to accelerate embryonic stem cell research there, some worry that current [...]
A select group of medtech industry stakeholders calling themselves the Minnesota Medical Device Alliance (MMDA) have made their concerns known with the FDA over potential changes to the regulatory approval process. The group, comprised to a significant degree of venture capitalists with current or pending interests in medtech companies, met earlier this month w's Dr. [...]
The first annual Translational Regenerative Medicine Forum that was held April 6-10, 2010, and sponsored by the Regenerative Medicine Foundation highlighted the future promise and needs in this field encompassing succinctly: replacement tissues and organs cell therapies to restore function Other issues addressed include the perennial discussion of policy, funding and the challenges of stem [...]
The global market for tissue engineering and cell therapy products is set to more than quadruple from 2009 to 2018. Products in cell therapy and tissue engineering include includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical [...]
At a meeting of the FDA and the medical device industry, the FDA noted that its limited powers, such as in regulating products already on the market, in controlling how manufacturers label their products and even tracking devices when their manufacturers sell their business, may lead the agency to seek broader powers from Congress (see WSJ). Industry [...]
The FDA is moving at two speeds in the medical device approval process. On the one hand, the agency is taking a critical look at the 510(k), expedited approval process, which has come under fire for being too lenient. The process will certainly see some change, given the pressure ensuing from high profile device failures [...]
With over 150 active companies developing and market products for cell therapy and tissue engineering applications, the industry is rapidly growing. Increasingly complex cell, tissue and organ systems are being repaired, restored or even replaced. The MedMarket Diligence report #S520, “Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018″, details the [...]
There are some obvious trends and dynamics in medtech: Cost is now a central driver of much development – either as an advantage to be marketed (e.g., reduced recovery time) or as an upper limiter of features offered. Changes in the cost of doing business: demands for post-market surveillance, change in approval process (510K), physician [...]
A wide range of regulatory approval conditions are applied to wound management products. The decision about regulatory classification for a given wound management product lies with the regulatory authority of the country in which the product is to be marketed and the manufacturing site making the product comes within their jurisdiction by virtue of the [...]
Clinical protocols for the treatment of specific wounds can vary considerably from country to country. Venous stasis ulcers, which account for approximately 4% of wounds and 75% of leg ulcers, are treated with short stretch compression bandages in Germany, elastic adhesive bandages in Italy, high compression bandages in France and multi-layer compression systems in the [...]
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