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
The market for tissue regeneration has finally arrived, or so believes Shire Regenerative Medicine Inc., which, on $38 million...
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Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.
CDX is eying applications for its pump platform that go beyond ECMO. The company’s CEO says smart pumps that can be fine-tuned to patient volume and configuration are needed, and CDX is creating a scalable solution capable of supporting both acute and chronic lung care.
