Bio-Rad Laboratories Inc. has launched its SARS-CoV-2 Total Ab test, which is a blood-based assay to identify all the antibodies that are developed by the human body in response to the novel coronavirus SARS-CoV-2. Companies have been racing to offer serological tests that work to detect the antibodies developed during a COVID-19 infection that remain present in the blood after the initial infection clears.
Temporary cardiac pacing is often required for hospitalized cardiac patients, particularly for increasingly common transcatheter aortic valve replacement (TAVR) procedures. Startup Atacor Medical Inc. has raised a $25 million series B round to back its development of a novel extracardiac temporary pacing system. Intriguingly led by an undisclosed corporate partner, the financing is slated to get the company through a U.S. and European pivotal trial, as well as regulatory review in those regions. The San Clemente, Calif.-based startup also aims to continue developing interim and permanent iterations of its system.
Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV technology for use in COVID-19 treatment.
Portland, Ore.-based startup Viscardia Inc. has received breakthrough device designation from the FDA for its implantable Visone system to treat moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony. The minimally invasive implant works by stimulating a specific portion of the diaphragm.
Molecular diagnostics firm Caris Life Sciences has launched a next-generation sequencing-based assay to analyze the whole exome of 22,000 DNA genes. Known as MI Exome, it builds on the existing whole transcriptome sequencing product MI Transcriptome that analyzes 22,000 RNA genes, as well as its microbiome analysis.
Pi-Cardia Ltd. has raised a $27 million round of financing led by Sofinnova Partners. The Rehovot, Israel-based company will use the round to back parallel U.S. feasibility and European pivotal trials of its catheter-based, nonimplant heart valve calcification treatment.
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.
Case Western Reserve University spinout Synapse Biomedical Inc. has received emergency use authorization from the U.S. FDA for its Transaeris diaphragm pacing system (DPS) device to prevent and treat ventilator-induced diaphragm dysfunction (VIDD).
Johnson & Johnson (J&J) managed to beat analyst earnings estimates due to unexpectedly strong first-quarter results in its consumer health and pharmaceutical businesses. But while those saw revenues climb in the double digits, its medical devices business declined by almost 5% due to deferred procedures. Wall Street rewarded the New Brunswick, N.J.-based company by driving its shares (NYSE:JNJ) up more than 5%. That’s even though the company also lowered its 2020 guidance.
The collection of nasal and throat swab samples to detect the presence or absence of the novel coronavirus SARS-CoV-2 has proven problematic on a few fronts, particularly in the U.S. The swabs themselves often have become scarce and difficult to obtain, while health care workers are routinely risking their own health commonly in the absence of proper protective equipment. In addition, sampling difficulties have largely been blamed for a very high false negative rate that could be as much as 25%.
