PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.

The Medicare inpatient draft for fiscal 2022 reflects the effects of the COVID-19 pandemic on claims data for a large number of devices, including those that received additional reimbursement under the new technology add-on payment (NTAP) program. Device makers are urging CMS to add a second year of extension to those NTAP payments, however, a proposal which if adopted would give the affected device makers additional time to recoup their investments.

Medtronic plc kicked off an app-based research study to improve understanding of atrial fibrillation (AF) disease burden and its impact on patient outcomes, quality of life and health care utilization. The first patients in the DEFINE AFib study were enrolled at Duke University Medical Center and the Florida Electrophysiology Associates in Atlantis, Fla. “When it comes to managing atrial fibrillation, there is not a ‘one-size-fits-all’ approach, and the hope is that DEFINE AFib may give us the tools to help personalize AF management based on a patient’s individual health profile and physiology,” said Jonathan Paul Piccini, director of cardiac electrophysiology and associate professor of medicine at Duke University School of Medicine and chair of the DEFINE AFib Steering Committee. “DEFINE AF will harness the power of digital health to make fundamental discoveries about how we can manage atrial fibrillation better in each and every one of our patients.”

As a first step in developing a portfolio of COVID-19 therapies, the European Commission identified five promising candidates June 29, including four monoclonal antibodies under rolling review at the EMA and an immunosuppressant that could have its marketing authorization extended to include the treatment of COVID-19 infections.

The FDA has posted an update on its surveillance of adverse events for bronchoscopes, noting that the number of medical device reports (MDR) has risen to between 100 and 200 such reports per year in the U.S. However, the agency noted that there are half a million procedures performed with these devices each year in the U.S. alone, and that these data are insufficient to infer a specific incidence of adverse events.

While stakeholders have concerns about the costs of registries for medical devices, they are still generally seen as less expensive and simpler to administer than randomized, controlled clinical trials (RCTs). A new journal article compares the quality of the data from a registry and the data generated by a clinical trial, and despite an interest in ascertaining whether registry data provided similar data quality, the authors concluded that registry data is still more useful as a means of supporting, rather than supplanting, the RCT.

PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.

As cyberattacks on U.S. hospitals continue to increase with health care’s growing reliance on technology, a new report from the U.S. Office of Inspector General (OIG) has flagged Medicare’s requirements for being silent on the cybersecurity of networked medical devices. The OIG’s study found hospitals are not required to identify networked device cybersecurity in their emergency preparedness risk assessments, and as a result, they don’t include this information “very often.”