The U.S. Centers for Medicare & Medicaid Services (CMS) has imposed a 60-day delay in the implementation of the Medicare Coverage of Innovative Technologies (MCIT) program, stating that the MCIT draft rule was developed under a flawed assumption about the volume of eligible breakthrough devices. CMS said the situation suggests that the public did not have an appropriate opportunity to comment on the proposed rule, a predicament that suggests the possibility that the MCIT program might not survive the Biden administration’s regulatory review.
LONDON – Following circulating tumor cells and cell-free tumor DNA, a new type of liquid biopsy is poised for commercial rollout after Datar Cancer Genetics Ltd. secured CE marking for Trublood, a method for isolating tumor cell clusters. In fact, the clusters do not consist solely of tumor cells, but can also include endothelial cells, erythrocytes, stromal cells, leukocytes, platelets, and cancer-associated fibroblasts. They are held together by cell-to cell-adhesion proteins.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA comments on two patent term extensions; Comment period reopened on Orange Book patents.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Fujifilm, Olympus Medical, Pelican Diagnostics.
Most of the med-tech companies doing business during the COVID-19 pandemic are experienced and already have their FDA compliance systems in place. However, Dennis Gucciardo, a partner at the D.C. office of Morgan, Lewis & Bockius LLP, told BioWorld that while the FDA will give industry sufficient time to transition their emergency use authorizations (EUAs) to conventional premarket filings, the cost of setting up a quality management system may be greater than some current EUA holders are willing to bear.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of infusion sets; Recall announced for Roche testing systems; NIH announces technique for improved photoreceptor imaging.
The U.S. FDA has granted emergency use authorization (EUA) to Breath Direct Inc. for its BDR-19 critical care ventilator for the treatment of critical care patients with respiratory insufficiency. Initial shipments of the device are expected within weeks. The EUA marks a major milestone for the fledgling Long Beach, Calif.-based company, which was started by medical device entrepreneur Darren Saravis in the early days of the pandemic.
The Advanced Medical Technology Association’s (Advamed) new board chairman, Michael Minogue, president and CEO of Abiomed Inc., noted that the association’s agenda for 2021 includes considerations of several headwinds. However, Advamed President and CEO Scott Whitaker said the Medicare Coverage of Innovative Technologies (MCIT) program should commence March 15 as planned, despite the overhang of the Biden administration’s regulatory review of all orders posted in the last days of the Trump administration.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIH touts new polygenic risk score methodology; HHS extends comment period for HIPAA NPRM.
RSS
