Neurotech startup Synchron Inc. connected its brain implant to Apple’s Vision Pro headset, enabling patients with limited physical mobility to control the device using only their thoughts. Synchron is building an endovascular brain-computer interface designed to help patients with paralysis operate technology like smartphones and computers with their minds.
In just its second PCT filing, Ykrita Lifesciences Private Ltd. (YLS) continues to assemble intellectual property for its development of an extracorporeal bioengineered dual-cell liver regeneration (EBDLR) system which serves as a lightweight, portable, ectopic liver device to aid in the rejuvenation of the body’s own liver and treat acute liver failure without the need for surgery.
Reliance may be the regulatory buzzword of the moment, but mutual recognition agreements between regulators are much more near and dear to the hearts of device makers. Richard Phillips, director of strategy for Association of British Health Tech Industries Ltd., told an audience of device makers that the U.K. is considering recognition of devices approved and cleared by the FDA, although Phillips said such recognition for 510(k) devices might be less than a simple exercise.
The 2.3% tax on medical devices is a thing of the past. Now, Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), has revealed to BioWorld that the supporters of the Affordable Care Act (ACA) saw the tax as little more than “a spreadsheet exercise” in financing the more costly elements of the legislation.