Responding to the growing number of state-sponsored cyber threats to health care and other key sectors and to the compromise of the Microsoft Exchange Server, which was disclosed in March, Canada, the EU, U.K., U.S. and other NATO allies issued statements July 19 laying out expectations and markers for how responsible nations behave in cyberspace and specifically calling out China’s “malicious cyber activity.”

Aditxt Technologies Inc. enhanced its immune response test for COVID-19 by adding a high-sensitivity neutralizing antibody quantification. With the expansion, the multidimensional test, Aditxtscore, provides a comprehensive measure of the strength of an individual's immune response to the novel coronavirus.

The FDA is applying a good deal of resources toward a framework for regulation of artificial intelligence (AI) and machine learning (ML), but there are several sources of drag on those efforts. According to the FDA's Jana Delfino, one of these is that there is little agreement between regulators on a number of definitions, including the meaning of terms such as "validation," a problem she said must be solved if the field is to advance in a meaningful manner.

The FDA has granted breakthrough device designation to Endologix LLC for its Chimney Endovascular Aneurysm Sealing (ChEVAS) system. The device, which is intended for use in treating aortic aneurysms, is currently being evaluated in a multicenter pivotal study. The ChEVAS system is an endovascular abdominal aortic aneurysm (AAA) therapy designed to combine the Nellix 3.5 endograft with parallel visceral chimney stents to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA.

On the heels of enrolling the first patient in a pivotal trial of a ventricular restoration system to treat symptomatic heart failure patients in January, Ancora Heart Inc. closed $80 million in new financing on Monday. The startup company plans to use the new funding to speed up this pivotal trial in preparation for FDA approval of its Accucinch ventricular restoration system.

Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.

Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA.

The COVID-19 pandemic brought in-person inspections of device manufacturing sites to a near halt, but that has left the agency with a significant backlog in these inspections. The FDA’s Associate Commissioner for Regulatory Affairs Judith McMeekin said recently that the FDA is intent on prodding Congress to provide the Office of Regulatory Affairs (ORA) with more monies, particularly given the meager increases in funding for oversight of the med-tech industry in the past few years.