Life science companies doing business during a pandemic may believe that patients, judges and juries will look kindly on products that don’t perform as promised, but that may be an empty wish. Angela Seaton, an attorney with the D.C. office of Shook, Hardy & Bacon LLP, advised that companies that want to break into new markets because of pandemic-specific demand should do their homework, including a review of U.S. FDA warning letters.

Transit Scientific LLC’s XO Cross Microcatheter platform was used in its first cases worldwide last week following its May 2020 clearance by the U.S. FDA and showed improved control and imaging. The company designed the platform to facilitate guidewire support, guidewire exchange, and contrast media injection during complex peripheral vascular interventions such as late-stage peripheral artery disease (PAD) and critical limb ischemia (CLI).

The COVID-19 pandemic has spurred a considerable amount of testing innovation, including more extensive use of saliva as a medium for detection of pathogens. The U.S. FDA has announced an emergency use authorization (EUA) to Yale School of Public Health for the Salivadirect testing protocol that requires no extraction of the SARS-CoV-2 virus’s RNA, a feature that Assistant Secretary for Health Brett Giroir said is “yet another testing innovation game changer that will reduce demand for scarce testing resources.”

In a controversial move, the American Cancer Society (ACS) recently recommended that people with a cervix should have a primary human papillomavirus (HPV) test every five years starting from age 25 to 65 to screen for cervical cancer. The recommendations displace the Papanicolaou (Pap) test that has formed the backbone of cancer screening for decades and extend the time between tests by two years.

Qui tam litigation holds a dear place in the hearts of U.S. federal prosecutors and whistleblowers alike, but the volume of these cases ebbed as the COVID-19 pandemic swept across the nation. A report by Gibson, Dunn & Crutcher LLP makes clear, however, that despite the pandemic-induced drag, these cases are resuming their historical pace, and makers of drugs and devices are once again the most frequently targeted type of business.

HONG KONG – Incheon, South Korea-based Celltrion Inc. is planning to launch two of its three rapid test kits in the U.S. as it plays its part in the global fight against the COVID-19 pandemic. Celltrion said Aug. 12 that its Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits will launch in the U.S. by the third week of August.

Two decades after the federal government jumpstarted U.S. R&D investment in its understanding and control of nanoscale matter, funding for the efforts across the government reached about $1.4 billion in fiscal 2020, part of a total cumulative investment of about $29 billion. Though FDA-budgeted nanotech research has accounted for just a fraction of that, at a modest $133 million since 2009, substantial advances have still been made, according to a presentation on the state of nanotech progress and innovation issued this summer.

In a single draft coverage memo, the U.S. Centers for Medicare and Medicaid Services (CMS) proposed to eliminate national coverage for artificial hearts and to provide coverage of ventricular assist devices (VADs) coverage for those in need of short-term ventricular support. Coverage of artificial hearts would thus revert to Medicare administrative contractors, while the change in VAD coverage would resolve a long-running dispute between cardiologists and the agency.

Much of the research on the immune response in patients with COVID-19 has focused on the humoral antibody response. Adaptive Biotechnologies Corp., on the other hand, has focused on cellular immunity to measure the T-cell response to infection with SARS-CoV-2.