Developed by Infrascan Inc., the FDA-cleared Infrascanner device was touted as the first hand-held device to help detect bleeding in the skull and supported financially by the U.S. military anxious to treat moderate to severe traumatic brain injury in wounded service members. The FDA has now expanded the Infrascanner’s use to traumatic intracranial hematomas or brain bleeds in pediatric patients aged 2 years and older.

Ceros Capital Markets completed a $15 million series D funding round for Pristine Surgical LLC, its latest major investment in the medical device space. The funds will be used to advance the commercialization of Pristine’s single-use visualization platform for surgical and diagnostic endoscopic procedures.

For about one-third of stroke patients, the cause of their cerebrovascular accident (CVA) is unknown at the time of hospitalization, but crucial to determine to prevent subsequent strokes. Electrocardiogram (ECG) monitoring in the 24 to 48 hours after a stroke detects atrial fibrillation (AF) in about 5% of patients. Remote monitoring with a noninvasive device detects far more cases and provides the opportunity to quickly head off secondary strokes, preserving lives and reducing costs of care, according to a study published by Royal Philips NV researchers.

The Biden administration sees the $15.6 billion just provided by Congress as inadequate funding for the pandemic, particularly given the administration’s new test-to-treat initiative, and will continue to press Congress for the remaining $6.9 billion requested by the White House, said Tom Inglesby, senior advisor for the White House COVID response team, at the American Clinical Laboratory Association annual meeting.

Sense Biodetection Ltd. is preparing to launch a new rapid, disposable, point-of-care molecular diagnostic test for COVID-19 in Europe after securing CE marking for the platform. The company will make its Veros COVID-19 test available in Ireland, Benelux and Nordic countries this quarter before expanding to other European markets.

The FDA continues its tight surveillance of rapid antigen tests for the COVID-19 pandemic and has issued three safety communications advising against the use of these tests thus far in the month of March. In each instance, the test is made by the manufacturer of name, but was not authorized in the U.S., making these misbranded products despite their legal use in other nations.

The news from Quanterix Corp. has come fast and furiously this week. The company reported that Chairman and CEO Kevin Hrusovsky will step down on April 25 and become executive chairman of the board, while current company President Masoud Toloue will assume the CEO position and join the board of directors. Hrusovsky became CEO in 2014 and Toloue joined Quanterix in June 2021 from Perkinelmer Inc. The company also revealed that it has built on its collaboration with Indianapolis-based Eli Lilly and Co. for new tools to diagnose, monitor and treat Alzheimer’s disease (AD) and presented its fiscal 2021 financial results, which showed a 28% increase in total revenue, largely attributable to its neurology segment.

Cvaid Medical Ltd. secured $4 million in a series A financing to further develop its mobile stroke diagnostic, monitoring and treatment platform. The Israeli Rad Biomed investment fund led the round with participation from Philips Ventures and Sanara Capital. As part of the financing, a representative from Philips will join the board. The smartphone-based system, Cvaid uses artificial intelligence to process and analyze video and voice recordings to identify and assess the severity of patients experiencing stroke, also called cerebrovascular accidents.

A Seattle-based startup has secured breakthrough device designation for its blood-based Alzheimer’s disease (AD) test. Altpep Corp.’s Soba-AD platform is designed to selectively detect toxic forms of amyloid-beta peptide associated with AD progression. The company said early data indicated the assay can detect AD before symptoms including cognitive impairment and neurodegeneration arise.

PARIS – Ziwig SAS has developed the Endotest saliva test, for quickly detecting endometriosis. François Golfier, head of the gynecology-obstetrics department at Angers University Hospital and chairman of the endometriosis committee for the National College of French Gynecologists and Obstetricians, claims this new generation of in vitro diagnostic medical devices is going to be a game-changer “as it finally allows this chronic debilitating disease to be detected sooner and within the space of just a few days.”