Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardio Flow, Lumiradx, Net Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuray, Astrazeneca, Grail, Limbus AI, Silk Road Medical.
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.
Healiva SA, a Swiss wound care specialist, emerged from stealth mode having acquired two cell therapy assets from Smith & Nephew plc. Financial terms were not disclosed, but they included an up-front payment as well as “deferred benefits,” Healiva CEO and founder Priyanka Dutta-Passecker told BioWorld. The deal means that the Lugano-based company – which was formed in 2020 – could be booking revenues as early as 2023.
Vitestro BV is preparing for pivotal clinical studies of its automated phlebotomy device after unveiling the prototype to clinicians in the Netherlands.
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.
Based on an evaluation of 10 artificial intelligence algorithms for diabetic retinopathy screening, the U.K. National Screening Committee (NSC) recommended Eyenuk Inc.’s Eyeart system as the only one ready for live clinical implementation. The system will be rolled out first in the North East London National Health Service (NHS) Diabetes Eye Screening Program (DESP).
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