Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S. The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF.

CMS has posted the draft Medicare inpatient rule for fiscal year 2022, replete with the usual controversies over reassignment of procedures under the Medicare diagnostic grouping system. One bit of good news is that the agency may carry over several expired new technology add-on payments (NTAPs) into the coming fiscal year, a move prompted by the difficulty of collecting claims data from fiscal year 2020 due to the COVID-19 pandemic.

Shares of Protalix Biotherapeutics Inc. (NYSE:PLX) fell 33% to $3.93 on April 28 after the company reported receiving an FDA complete response letter (CRL) in answer to its BLA for pegunigalsidase alfa, a galactosidase enzyme replacement therapy it has long advanced for the potential treatment of Fabry disease.

If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), both Keytruda and Tecentriq will remain on the U.S. market, for the time being, with accelerated approval as first-line treatments for certain patients with advanced or metastatic urothelial carcinoma. The committee voted 5-3 April 28 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) and 10-1 for maintaining the accelerated approval of the Roche Group’s Tecentriq (atezolizumab) until the final data come in from a confirmatory trial that’s expected to be completed next year.