As the U.S. Congress continues to pass laws that require federal agencies to issue rules to implement new statutory provisions, a group of lawmakers is reminding the agencies that it will be looking over their shoulders to ensure they don’t stray beyond the scope of the law or overstep their authority.
New U.S. SEC rules designed to reel back the special purpose acquisition (SPAC) market went into effect on July 1, yet only a few weeks later two such companies completed IPOs and are now targeting mergers with health care and life sciences firms, including biopharma and medical technology.
Australia’s Department of Health has released a new Aged Care Digital Strategy to increase the use of digital technology to enhance the care and wellbeing of older people in aged care facilities. By 2062, the number of people over 65 is expected to more than double, and the number of people over the age of 85 will more than triple. Australia’s aged care workforce is already under strain and will need to increase to meet this demand, a 2023 intergenerational report said.
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.
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