Semiconductors chips, a key component in many medical devices, continue to be in short supply as COVID-19-driven supply chain disruptions continue. The shortage comes at the worst possible time, with demand for the chips on an upward trend. Nano-x Imaging Ltd.’s (Nanox) solution to the shortage was to open a semiconductor chip fabrication plant in Yongin, South Korea, to produce Nanox.source, a semiconductor chip that replaces the filament in the analog X-ray tube.
Clinicians are still at liberty to use medical products outside the labeled indication for use, but the U.S. FDA believes radiologists may be unaware of the limitations of radiological computer-aided triage and notification (CADt) software for intracranial large-vessel occlusion (LVOs). The agency advised clinicians that these programs are not intended for use as a substitute for radiologist review of images, but instead should be used only to flag suspect images as part of an effort to triage these patients.
Acquisitions in the diagnostics space incurs some interesting liabilities, given recent case law regarding subject matter eligibility, but this is not the only trap door for the acquiring company. Roche Diagnostics Corp., of Indianapolis, managed to avoid an induced patent infringement charge by Meso Scale Diagnostics LLC in a recent hearing at the U.S. Court of Appeals for the Federal Circuit in connection with Roche’s 2007 acquisition of Bioveris Corp.
Diagnostic testing group Clinisys Inc. has acquired cloud-based laboratory operations software company Apollolims in an undisclosed deal. Headquartered in Chertsey, U.K., and Tucson, Ariz., Clinisys will expand its public health, toxicology, and molecular diagnostics offering through the acquisition. The deal builds on the company’s combination with Sunquest and Horizon announced in January.
Akili Interactive Labs Inc. has made grabbing and holding attention a distinguishing feature of its digital therapeutics and overall company strategy. Last month, it made news with its hire of gaming industry veteran Jon David as its chief product officer. Now, a study indicates a new product in development may help people with depression extend their attention span and possibly improve cognition, two common symptoms associated with the mood disorder that are not treated by most medications.
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