A number of entities have sounded off on the FDA’s discussion paper for artificial intelligence (AI), including several medical societies that would like to see autonomously operating algorithms subjected to more stringent review than supervised algorithms. Vibhor Rastogi, general partner at Symphony AI of Los Altos, Calif., told BioWorld that the company is on board with many of these concerns, adding that the FDA discussion paper does a “good job of balancing innovation and patient safety.”

A bioelectronic platform that stimulates the vagus nerve to reduce inflammatory activity and restore balance in the immune system is the ultimate aim of Setpoint Medical Inc. The Valencia, Calif.-based startup is preparing to start a U.S. pivotal trial for its most advanced program in rheumatoid arthritis (RA) later this year or early next.

The issue of the U.S. federal government’s response to the COVID-19 pandemic was revisited yet again in a hearing in the House of Representatives. While partisanship was on full display, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” about the prospects for a vaccine and that the development of candidates has not compromised scientific principles.

The U.S. Senate Finance Committee met for a second time in three days to address the supply of personal protective equipment (PPE) for the COVID-19 pandemic. While a witness said the Defense Production Act (DPA) is no panacea for production, one message emerging from the hearing is that producers need to hear from end users about demand just as much as users need to know about available inventories.

Hologic Inc. beat expectations for the third quarter of fiscal year 2020, posting net earnings of $137.9 million, or 53 cents a share, up 46.9% from the same period a year ago. Worldwide revenue declined 3.5% to $822.9 million, due to the divestiture of Cynosure Holdings Inc., but grew 7.7% organically (8.1% in constant currency), as demand for COVID-19 tests offset a slide in other businesses.

In a time when the FDA needs its best and brightest people onboard, nearly half the senior leadership at the agency will be eligible for retirement by Sept. 30.

The U.S. government has charged two citizens of China with cybercrime in connection with purported hacking of research into vaccines for the SARS-CoV-2 virus, but more than one speaker on a July 22 webinar said scientists involved in basic life science research at universities fail to appreciate the need for cybersecurity, a problem they may take with them to the private sector.

The alleged activities of two Chinese hackers outlined in a federal indictment unsealed Tuesday offer “concrete examples of two concerning trends,” U.S. Assistant Attorney General John Demers said, as U.S.-China relations further soured with the news of the charges.

Diagnostics testing company Laboratory Corp. of America Holdings Inc. (Labcorp) saw its second-quarter revenue decline by 4% to $2.8 billion, but that still beat the Street consensus of $2.5 billion. Diagnostics revenue fell 3.9% year over year to $1.7 billion, but that was offset by solid demand for the company’s COVID-19 tests.

The U.S. Senate Finance Committee held the first of its two hearings on the supply chains for a variety of products vital to the response to the COVID-19 pandemic. While electoral politics were on full display during the hearing, a recurrent theme was the need to bring supply chains back to the Western Hemisphere as a solution to the fraudulent products shipped to the U.S. from Hong Kong and China.