The U.S. FDA’s Center for Devices and Radiological Health has rewired its organizational structure on several fronts, including a promotion of its communication function into a “super office,” which the agency said will help it be more agile and responsive to its strategic priorities.
There is no doubt that artificial intelligence, automation and robotics are transforming today’s laboratories. At the forefront of these changes is Automata Technologies Ltd., which has developed the Linq platform to digitally and robotically connect all the components of a modern life sciences lab to create fully automated end-to-end workflows.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alveo Technologies, Augmedix, Commure, Olympus.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inspire Medical Systems.
Novocuff Inc. closed an oversubscribed $26 million series A funding round to support further development of the Novocuff cervical control system, which is designed to reduce preterm births by closing the cervix in high-risk pregnancies. The funds will enable the company to undertake a U.S. multi-center pivotal clinical trial, pursue marketing authorization, expand its team and begin early-stage commercialization of the device.
The coverage with evidence development (CED) process employed by the U.S. Medicare program may suffer from underutilization, but the authors of a new article in Value in Health see the attendant problems as administrative in nature. The issues include, but are not limited to, a lack of predictability as to when a CED study would be required for coverage of a medical device.
GE Healthcare Technologies Inc. entered into a conditional agreement to acquire the clinical AI business of Intelligent Ultrasound Group plc for £40.5 million (US$51 million). The deal is part of GE Healthcare’s effort to bolster its portfolio of artificial intelligence-enabled devices and strengthen its ultrasound business.
Researchers from the University of Southern California filed for protection of a thin film electrode array they developed to be implanted using endovascular methods for minimally invasive, high-resolution electrical recording and stimulation of the nervous system and other electrogenic tissue.
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