Dermagraft is often mentioned as an example of a failure in tissue engineering, illustrating the difficulty of achieving return on investment in this field. The product was only a market failure, however; clinicians say that it worked to heal difficult wounds, and that it was just a product ahead of its time. Now small company Advanced BioHealing has given new life to the bioengineered dermal substitute, abandoned by Smith & Nephew, by supporting it with the focus, and the unique marketing and manufacturing skills that tissue-engineered products require. In the process, it believes it has created assets and skill-sets from which other tissue-engineering start-ups might benefit.
Mary Stuart
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The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.
The US FDA has announced seven device safety actions in recent days. The most serious, which relates to a manufacturing defect in Boston Scientific’s Accolade pacemaker, has been linked to 832 injuries and two deaths.
EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.
This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.
