Physician ownership of medical device manufacturers can be tricky stuff where the Anti-Kickback Statute is concerned, but the Office of Inspector General recently declared it had no problem with one such arrangement due to the physician’s ratio of ownership of the company.

The U.S. Government Accountability Office said in a recent report that the Medicare national coverage determination process could use a few adjustments, but the report also pointed to significant resource problems associated with the process, a source of drag that only Congress can fix.

Speaking at a Sept. 9 media briefing on the newly released Make America Healthy Again Strategy, U.S. Health and Human Services Secretary Robert Kennedy confirmed what could be the worst fears of many vaccine experts.

Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.

Elutia Inc. agreed to sell its Elupro and Cangaroo bioenvelopes for implantable medical devices to Boston Scientific Corp. for $88 million in cash. Elutia will use the funds to further development of NXT-41x, an antibiotic biomatrix designed to reduce post-surgical complications in breast reconstruction.

The U.S. Office of Inspector General said in a recent report that independent testing labs should be required to develop emergency preparedness plans for public health emergencies, a move that would affect industry giants such as Laboratory Corporation of America and Quest Diagnostics Inc.

Heartbeam Inc.'s algorithms performed as well on a standard 12-lead electrocardiography (ECG) as on its 3D ECG system in the detection of atrial fibrillation, atrial flutter and sinus rhythm, based on a study presented by Joshua Lampert, cardiac electrophysiologist and medical director of machine learning at HRX Live 2025 in Atlanta.

The U.S. Office of Inspector General posted an analysis of Medicare spending on skin substitutes, remarking that the data suggest a disproportionate use of these products for patients enrolled in fee-for-service (FFS) care.

Edwards Lifesciences Corp. fully acquired Vectorious Medical Technologies Ltd. for $497 million, following a series of investments in the heart failure technology company over the last five years.

Sometimes little things can create big problems, which seems to be the case with the recall of the power unit used with the Abbott Heartmate 3 left ventricular assist device (LVAD). According to the FDA recall announcement, the power cords used with the power supply might not stay fixed in place, which would leave the power supply with 15 minutes of backup battery runtime before depletion.