The International Medical Device Regulators Forum (IMDRF) has posted a draft guidance for cybersecurity practices for legacy devices, a nod to the number of older devices that are difficult to secure. This document is a follow-up to a standing IMDRF guidance that spans the product life cycle, but which apparently left stakeholders with a few questions.
About 1,500 babies are born each year in the U.S. with microtia, which happens when the external ear is small and not formed properly, but 3Dbio Therapeutics Corp., and the Microtia-Congenital Ear Deformity Institute (MCEDI) of San Antonio have brought to patients a solution that avoids biocompatibility issues seen with existing solutions. The Auri Novo device, a 3D-printed reconstruction of the outer ear that leverages the patient’s own ear cartilage, eliminates the need to harvest rib cartilage or use porous polyethylene in lieu of native cartilage, another indication that the era of personalized medicine is finally in view.
Drug and device makers are necessarily wary of any activities that could lead to prosecution under the False Claims Act (FCA), but seemingly innocuous activities are now fair game for federal prosecutors. The latest example is the FCA prosecution of Caris Life Sciences for filing claims for cancer tests outside the 14-day post-discharge window, and Mark Gardner, directing attorney at Gardner Law of Stillwater, Minn., told BioWorld that device makers should be on the alert because it appears that federal authorities are ramping up enforcement.
Camera pills were never quite like this. Developed by Vibrant Gastro Inc. for people suffering from chronic idiopathic constipation (CIC) the Vibrant system capsule is designed to travel deep into the gut and vibrate, augmenting the natural mechanisms of the body that govern bowel function.
The U.S. Cybersecurity & Infrastructure Security Agency (CISA) said the Synapsys microbiology informatics software platform has an access vulnerability due to an inadequate session expiration mechanism. Becton, Dickinson & Co. (BD), the publisher of the Synapsys system, said three versions of the software are vulnerable, but this vulnerability can be exploited only by those with direct access to the workstations, making this a lower risk than some other recently reported vulnerabilities.
The U.S. Department of Justice and the Securities and Exchange Commission have separately indicted Marc Schessel and his company, Scworx Corp., for making false statements about the company’s ability to provide rapid tests for the COVID-19 pandemic. The indictments include allegations that Schessel and his company had been advised that the tests they had intended to procure were no longer available for distribution in the U.S., but that the Schessel did not advise shareholders of this fact for another 11 days.
A start-up rival to Illumina Inc. has emerged from stealth mode, debuting a new low-cost gene sequencing platform, the UG 100. Ultima Genomics Inc. has raised approximately $600 million from investors including General Atlantic, Andreessen Horowitz, D1 Capital and Khosla Ventures to scale development of the whole-genome sequencing, single-cell sequencing technology. Initial data using the platform to sequence more than 200 human genomes will be presented at the upcoming Advances in Genome Biology and Technology (AGBT) conference.
The FDA announced a class I recall of the Dragonfly Opstar imaging catheter by Abbott Vascular, of Santa Clara, Calif., due to the loosening of a band marker that may lead to separation from the catheter. The agency said two instances in which the marker has separated from the catheter have been reported, with another three incidents of loosening without separation.
The U.S. Court of Appeals for the Federal Circuit has ruled again on the appointments clause questions evolving from a patent dispute between Arthrex Inc. and Smith & Nephew Inc., this time in connection with a former acting director of the Patent and Trademark Office (PTO).
Ethicon Endosurgery Inc. and Intuitive Surgical Inc. have been sparring in the courts over patents for robot surgery systems for some time, and the U.S. Court of Appeals for the Federal Circuit has ruled on yet another of those disputes.
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