Medical Design and Outsourcing

Medical Design & Outsourcing’s parent company, WTWH Media, today announced it has rebranded as Arrowfly.  The new name and identity reflect the company’s transformation from a specialized trade publisher into an omnichannel B2B media, events, and marketing company where hard-to-reach professional decision-makers gather for trusted journalism, industry intel...

Sentante is another step closer to treating patients with its remote endovascular robotics system after earning CE mark approval in May. “This is a defining moment for Sentante,” Sentante co-founder and CEO Edvardas Satkauskas said in a news release. “We are now positioned to move decisively into commercialization and begin delivering real impact for clinicians…

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Auxilium Biotechnologies says it bioprinted kidney and liver tissues aboard the International Space Station in the “first demonstration of a scalable, multi-product biomanufacturing platform in space.” The San Diego-based biotech and device developer used its Auxilium Microfabrication Platform (AMP-1) 3D bioprinter for the first-of-its-kind mission, which also included orbita...

A faster pre-submission track, earlier communication for de novo applicants and an “international harmonization” pilot program are among proposed improvements and changes featured in the FDA’s latest draft Medical Device User Fee Amendments (MDUFA) agreement. The agency recently released a draft commitment letter, detailing its proposed agreement with the medtech industry for...

Navigantis says it has what it takes to win the race to treat stroke patients remotely with its interventional robotic platform VASCO, which is already being used in a clinical trial for neurointerventional procedures. Stroke telesurgery is one of the biggest opportunities in medtech. Major OEMs and startups barely out of stealth mode are racing…

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