Medical device manufacturers based in China may feel the FDA has a bullseye on their backs, but two firms located in Canada were the subjects of recently posted FDA warning letters.
In what undoubtedly came as a response to Medtronic plc’s recently reported Small Annuli Randomized to Evolut or SAPIEN Trial trial results that showed a decisive advantage for its Evolut transcatheter aortic valve replacement system in patients with a small aortic annulus, Edwards Lifesciences Corp. reported the results from an analysis of data from its Placement of Aortic Transcatheter Valve trials of the Sapien 3 valves showing “excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or sex.”
Isotope Technologies Munich SE (ITM) raised €188 million ($204 million) in a funding round that will largely be used to advance and expand the company’s radiopharmaceutical pipeline. The funds, which come a year after ITM raised €255 million, are a sign of growing investor interest in the company’s products and the radiopharma market, Steffen Schuster, CEO of ITM, told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Intuitive, Moon Surgial.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amco, Body Vision Medical, Dexcom, Glucotrack, Heart Test Laboratories, Pathmaker.
A collaborating team of researchers from Northwestern University and Rice University continue to build intellectual property for an implanted biohybrid (bioelectronic/engineered cell) device that has been likened to an implantable pharmacy on a chip that never runs out.
Molecular diagnostics company Genetic Signatures Ltd. is gearing up to launch its Easyscreen gastrointestinal parasite detection kit in the U.S. following its first FDA 510(k) clearance.
Xeltis BV hopes that promising data from clinical trials on the performance of its synthetic vascular access graft implant will transform not only the lives of patients suffering from chronic kidney disease but also the company’s fortunes. “We're outperforming other solutions out there, that's the nice promise not only for the patient and for the families but also for potential strategics that might be interested in the company and play a role in the vascular space,” Eliane Schutte, CEO of Xeltis told BioWorld.
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