The U.S. FDA is actively working on guidance for conversion of emergency use authorizations (EUAs) to conventional premarket review programs, but the FDA’s Tim Stenzel said he does “not perceive a need to rush to convert EUAs” because of the volume of EUA applications, and because he does not expect the public health emergency “to end anytime soon.”

A new $23 million in funds gives Brainbox Solutions Inc. a head start as it begins enrollment in the pivotal clinical trial of its mild traumatic brain injury (TBI) diagnostic and prognostic test. Bioventures Investors took the lead in the series A financing. The Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, and Astia Angels participated in the fundraising round along with qualified investors including the Cleveland Cavaliers' Kevin Love, a mental health advocate.

HONG KONG – Votis Subdermal Imaging Technologies Ltd. is developing a diagnostics solution that could prevent the loss of feet among India’s impoverished due to affects of peripheral artery disease (PAD). The company has entered an agreement with India’s Ii Ventures Pte. Ltd. (iiV) to develop a system to screen the largely rural Indian population for PAD.

Hologic Inc., which focuses on women’s health, said Jan. 4 that it has completed the acquisition of Somatex Medical Technologies GmbH for roughly $64 million. Based in Berlin, Somatex focuses on minimally invasive devices for tumor diagnostics, biopsy and interventional specialties. Somatex’s portfolio includes biopsy site markers and localization technologies, including Trumark markers. The company was previously owned by E-Med Solutions GmbH, a group of investors led by German private equity firm Westlake Partners.

Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.

HONG KONG – A new algorithmic module developed by Rsip Vision Ltd. makes it possible to generate automated expert-level assessment of heart functions, facilitating quick and reliable detection of cardiac illness and heart attacks.

The U.S. FDA has granted emergency use authorization (EUA) to Quanterix Corp.’s SARS-CoV-2 IgG antibody test, which tests blood samples for evidence of recent or prior COVID-19 infection. The test could also be used to measure antibody response to a COVID-19 vaccine. The Simoa Semi-Quantitative SARS-CoV-2 IgG antibody test is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and dipotassium EDTA plasma from a venous blood draw.

Two-Photon Research Inc. (TPR) has launched a diagnostics platform it said improves coronavirus detection via aptamers, small molecules that change shape when binding to a protein at the surface of the SARS-CoV-2 molecule that causes COVID-19. Light shone onto a vial containing a patient’s saliva and the Aptamer Molecular Photonic Beacon (AMPB) generates negative or positive results that are instantly displayed on a smartphone and stored for planning purposes by public health officials.

Coagulo Medical Technologies Inc. raised $6.5 million in financing to accelerate delivery of its precision-medicine coagulation diagnostics platform. 20/20 Healthcare Partners led the investment with participation from Sands Capital, Good Growth Capital, IAG Capital Partners, and private investors. The company also received funding through a Small Business Innovation Research (SBIR) grant from the National Science Foundation to develop a COVID-19-related coagulation test.