Three former officials with Magellan Diagnostics Inc., have entered guilty pleas in connection with faulty tests for lead poisoning that were widely used across the U.S. between 2013 and 2017. While former CEO Amy Winslow and two others will not be sentenced until later this year, all three face possible prison terms of three years or more and fines of as much as $250,000, highlighting the hazards of a lack of scruples with regard to compliance with U.S. FDA regulations.

As expected, the U.S. Senate Health, Education, Labor and Pensions Committee voted March 13 to send the nominations of Jay Bhattacharya as NIH director and Martin Makary as FDA commissioner to the Senate floor for confirmation. Bhattacharya received a narrow 12-11 party-line vote, but Makary picked up some Democratic support to secure a 14-9 vote.

An Australian man in his 40s with severe heart failure was implanted with a Bivacor Inc. total artificial heart (TAH) and has been discharged from the hospital. He remained at home with the artificial heart for 100 days until he received a transplant earlier this week.

The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed. As an example, the Association for Molecular Pathology (AMP) said the draft’s recommendation for the use of 30 positive and 30 negative (30/30) samples for validation of lab-developed tests is likely to hamper test availability in an emergent situation, a time when samples are likely to be difficult to obtain.

The U.S. FDA’s latest draft guidance on pulse oximeters drew comment from the International Standards Organization and the International Electrotechnical Commission, which are making the case that in addition to differences in pigmentation, the pulsatility of the tissue in contact with the device is also a factor in device performance.

In another real-life episode of “sponsor beware,” the owners of a clinical research facility pleaded guilty March 10 in U.S. district court to fraud charges resulting from their conduct of two clinical trials for potential asthma drugs.

Sooma Oy secured U.S. FDA investigational device exemption approval to initiate a pivotal study of its transcranial direct current stimulation medical device in people with major depressive disorder. The study will examine the efficacy of the non-invasive Sooma 2Gen device in improving MDD as an at-home treatment.

Martin Makary, President Donald Trump’s pick to head the U.S. FDA, took his turn before the Senate Health, Education, Labor and Pensions (HELP) Committee March 6, a week ahead of the committee’s confirmation votes on both him and Jay Bhattacharya as the next NIH director. The committee votes will set the stage for the full Senate to vote on confirming both nominees later this month.

The U.S. FDA drafted a guidance for clinical trials for evaluation of optical imaging (OI) agents. The policy may allow clinical studies to evaluate an OI agent by means of an intrasubject study design, which would save time and money for the sponsor.