The U.S. Centers for Medicare & Medicaid Services (CMS) has decided to leave the onus on Medicare administrative contractors (MACs) to make coverage determinations regarding the Allomap test for heart transplant rejection despite a request for a non-coverage policy. As was the case in the decision to allow MACs to determine coverage for total artificial hearts, the CMS said that the low annual rate of utilization of the Allomap, by Caredx Inc., of Brisbane, Calif., suggested that the MACs are in a better position to make the appropriate call regarding coverage.

The COVID-19 pandemic’s direct and indirect toll on the human condition is beyond calculation, but the effect on FDA regulatory activity is easier to assess. The problem for device makers is that a number of draft and final guidances are stuck in a pandemic-driven regulatory limbo, which seemingly guarantees that some compliance and product development efforts will run afoul of the agency’s expectations and potentially delay a product’s market access.

Endologix LLC said Tuesday that it has completed the acquisition of Pq Bypass Inc., a privately held company developing a novel technology for treating severe peripheral artery disease (PAD). Pq Bypass’ Detour system is currently being studied in a U.S. and European clinical trial, DETOUR2.

Memic Innovative Surgery Ltd. secured a major cash infusion to bring its freshly FDA-authorized Hominis robotic-assisted surgical platform to market. Peregrine Ventures and Ceros led the $96 million series D financing round with participation from Ourcrowd and Accelmed.

Consolidation in diagnostics continues apace, with Diasorin SpA set to take over Luminex Corp. in an all-cash deal that values the multiplex diagnostics and molecular testing specialist at $1.8 billion. At $37 per share, the price is a 23% premium to the Luminex (NASDAQ:LMNX) share price on Feb. 23, which is when rumors of the acquisition began to circulate, and 12% above the close last Friday, April 8.