Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.

The U.S. Centers for Medicare & Medicaid Services (CMS) finally laid to rest the rule for Medicare Coverage of Innovative Technology (MCIT), a policy proposal that found favor with industry and with several patient groups. However, the news comes shortly after a bipartisan group of 10 senators had penned a letter to the agency to reissue the rule, reinforcing the prospect that the MCIT proposal will find widespread support in the halls of Congress in 2022.

The U.S. Department of Health and Human Services (HHS) has withdrawn its August 2020 rescission of the FDA’s authority to regulate lab-developed tests (LDTs), a reversal predicated on the need for additional testing capacity for the COVID-19 pandemic. However, the non-COVID implications are not clear as the FDA is not widely seen as having the capacity to regulate LDTs for non-pandemic purposes, while pending legislation would dramatically overhaul the agency’s approach to LDT regulation, making the current regulatory environment an unstable environment at best. The FDA accompanied the announcement with a statement that the emphasis at the agency is on tests that do not require that the patient sample be sent to a lab for processing.

The FDA has approved Pharmaessentia Corp.'s Besremi (ropeginterferon alfa-2b) for the rare blood disorder polycythemia vera, the interferon offering an alternative to JAK inhibitor therapy. PV is a rare, chronic and life-threatening blood cancer caused by a mutation in stem cells in the bone marrow, resulting in overproduction of blood cells. Besremi, which is already approved in Taiwan, Europe and South Korea, is a monopegylated, long-acting interferon, which counteracts the effects of the mutated bone marrow cells and is initially taken fortnightly.

The FDA’s device center has revisited the 2005 guidance for the content of premarket submissions for device software functions, a document that puts much more emphasis on risk compared to the legacy 2005 guidance.

U.S. President Joe Biden on Nov. 12 announced his intent to nominate former FDA Commissioner Robert Califf to return to the regulator’s top job. He would take the place of Janet Woodcock, acting commissioner of the agency since Jan. 20.

When the U.S. Congress resumes next week, its top priority will be the passage of a massive budget bill that once again includes long-promised – or threatened, depending on a person’s perspective – provisions intended to bring down prescription drug prices.

The U.S. NIH said it will go to court if necessary to defend its role in developing Moderna Inc.’s COVID-19 vaccine. NIH spokeswoman Renate Myles told BioWorld that the agency “is not giving up on our claim that NIH is a co-inventor on the mRNA technology used in the Moderna’s COVID-19 vaccine but defers to legal authorities on how this might be resolved.”

Ultrasound companies, Caption Health Inc. and Ultromics Ltd. are linking up to jointly offer Caption’s AI software platform with Ultromics’ Echogo deep ultrasound analytics for cardiovascular disease detection.