Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3nt Medical, Abiomed, Healgen Scientific, Meditech Spine, Rhaeos, Siemens Healthineers, Tissue Regenix.
The Medicare inpatient draft is always an event due to its impact on medical technology. Now, several products soon may see their new technology add-on payments (NTAP) expire because of eligibility. The Centers for Medicare and Medicaid Services (CMS) said both Claret Medical Inc.’s Sentinel embolic protection device and Procept Biorobotics Corp.’s Aquabeam device have used up their NTAP eligibility, and hospitals may see lower rates for using those devices starting Oct. 1
The U.S. FDA granted an emergency use authorization (EUA) for Quest Diagnostics Inc.’s self-collection kit for COVID-19. The kit allows individuals to collect their own specimens at home or in a health care setting.
New York-based at-home testing startup Letsgetchecked said Friday that the U.S. FDA has granted emergency use authorization (EUA) for its COVID-19 Sure-track Test for signs of active SARS-CoV-2 infection. The polymerase chain reaction (PCR) nasal swab test is for use by at-risk individuals in the home and delivers results within 24 hours of a sample being received by the company’s CLIA-certified laboratory.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airos Medical, GE Healthcare, Gynesonics, Quest Diagnostics.
The impact of COVID-19 is being felt at the American Society of Clinical Oncology (ASCO) annual meeting as much as anywhere else, typically held at McCormick Place in Chicago but this year conducted virtually because of the pandemic.
The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism.
