Edwards Lifesciences Corp., of Irvine, Calif., petitioned the Centers for Medicare & Medicaid Services to revise the Medicare coverage policy for transcatheter aortic valve replacement (TAVR) devices on two points, the combination of which would make a big difference for TAVR devices across manufacturers. Edwards requested that CMS explicitly cover TAVR for asymptomatic aortic stenosis patients, a notion well supported by recent data, and bring an end to the coverage with evidence development mandate.

Companion Spine SAS received premarket approval from the U.S. FDA for its DIAM spinal stabilization system, for treatment of degenerative disc disease. The approval comes as the company recently completed the acquisition of a number of assets from Xtant Medical Holdings Inc., including Paradigm Spine GmbH, as it continues to strengthen its position in providing solutions to treat spinal degenerative conditions.

The U.S. FDA announced Dec. 15 that it will take a more relaxed approach to device premarket applications using real-world evidence from data sources that lack individual patient-level data, a switch that might ease manufacturers’ efforts to expand a device’s labeled indication for use.

Radiopharm Theranostics Ltd.’s radiotracer RAD-101 met the primary endpoint in 92% of patients in the phase IIb imaging trial in brain metastases, according to interim results. To date, 11 of the 12 patients treated with RAD-101 (F18-Pivalate) achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases. The results showed significant and selective tumor uptake, and images confirm metabolic activity in brain metastases compared to equivocal MRI findings.