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. 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.

Pivotal in killing the Biden administration’s Build Back Better budget legislation, Sen. Joe Manchin (D-W.Va.) is now working to revive parts of it, including the provision that would require Medicare to directly negotiate prescription drug prices.