Cytovale Inc., a San Francisco-based medical technology company, has snagged an additional $3.83 million in funding from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to conduct a pilot study of its Rapid Sepsis Diagnostic System for patients with potential respiratory infections, including SARS-CoV-2, the novel coronavirus responsible for COVID-19. The patented technology, which can diagnose sepsis in less than 10 minutes, could speed up triaging and treatment of critically ill patients suspected of having the life-threatening condition.

The Main Street Lending Program (MSLP) was designed to ensure that small businesses are able to stay in business during the economic damage incurred by the COVID-19 pandemic, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA) says the program’s provisions are leaving some small device makers out in the cold, a predicament MDMA is working to resolve.

The role of diagnostic and surveillance testing in the COVID-19 pandemic is unquestionably critical, but the volume and type of tests needed to bring the economy back online is complex. Susan Van Meter, director of Advamed Dx, said on an April 22 press briefing that while molecular and serological tests will continue to play a vital role, “we’re going to see millions of antigen tests available in the coming weeks,” a development that will prove crucial in efforts to restore normal economic activity.

The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy.

The Trump administration has proposed a policy to gradually reopen the U.S. for business, part of which is to allow a resumption of elective procedures and treatments in outpatient settings. While patients with urgent medical needs presumably are being treated already, the policy would seem to promise a boost in volumes for certain devices, such as coronary artery stents, knee implants and transcatheter aortic valve replacement (TAVR) devices, all of which enjoy at least limited Medicare coverage for outpatient use.

In a decision that seems to have yet again roiled the patent subject matter eligibility question, the U.S. Court of Appeals for the Federal Circuit determined that a district court had erred in determining the 7,941,207 patent held by Cardionet LLC, of Conshohocken, Pa., is not eligible for patent protection.

The largest study to date on hypermutated gliomas has delivered new insights into their origin, as well as their response to several different treatments. Specifically, even though they are hypermutated, such tumors are unlikely to respond to PD-1 blockers.

Robotic-assisted surgical procedures have fallen off steeply as the ongoing global pandemic has unfolded, but the real impact on Intuitive Surgical Inc. will come as its hospital customers may have to limit orders for expensive equipment upgrades as they struggle to manage unprecedented financial burdens. The U.S. accounts for about 70% of its robotic surgery procedures, but by the last few weeks in March, that activity had been curtailed by roughly two-thirds.

A recent Senate hearing raised the question of whether privacy and confidentiality are at risk when software is installed in smart devices for disease surveillance purposes, but there may be no absolute guarantee of confidentiality, jeopardizing the goodwill of citizens who are wary of big government.

Despite challenges associated with the ongoing COVID-19 pandemic, Abbott Laboratories saw its first-quarter revenue beating expectations, coming in at $7.73 billion vs. an expected $7.44 billion. Cowen’s Josh Jennings highlighted this result, adding in a note that while there are challenges for nondiabetes medical devices and core diagnostics, areas including diabetes, nutrition, the established pharmaceuticals division and COVID-19 testing shined.