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.
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.
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.
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.
The U.S. House Committee on Ways and Means held a field hearing in the State of Utah, during which committee chairman Rep. Jason Smith (R-Mo.), highlighted the need to continue to incentivize life science research in the U.S. Smith remarked that Republican members of the committee have formed “tax teams” to find ways that the tax code can be tweaked to “better incentivize research and development here in the U.S.,” another sign that the well-being of life science commerce is seen as a macroeconomic imperative in Washington.
Guardant Health Inc.agreed to pay more than $900,000 to settle allegations that the company’s human resources office hired a relative and a friend of a physician who persuaded the company to make the hires in a quid pro quo for orders of Guardant’s tests. The U.S. Department of Justice said the penalties could have been much greater but for the company’s cooperation in the investigation, which disclosed that at least one of these hires was not qualified for the position.
The U.S. Court of Appeals for the Federal Circuit has upheld a district court decision that Natera Inc. is entitled to an injunction of a Neogenomics Inc. assay for detection of circulating tumor DNA (ctDNA). This outcome serves as a sobering reminder that injunction can be obtained at the preliminary injunction stage by demonstrating that an effort to prove infringement is likely to succeed even in the absence of a thorough evaluation of the contested claims in that patent.
A dongle is not the sort of thing one typically associates with a medical device, but a charging dongle used with the Baxter Healthcare Life2000 ventilator has triggered a recall of both the dongle and the ventilator.
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