Makers of vitro diagnostics (IVDs) are facing several significant challenges in the next few years, thanks to existing and impending revisions to a number of regulatory frameworks. There are other considerations that are adding to the headwinds, such as a poor patent protection environment in the U.S., the net effect of which is to make life unusually miserable for developers of these tests.

Sonic Incytes Medical Corp. collected $7.3 million in a series A fundraising round to bring its liver-focused point-of-care ultrasound solution to commercialization. Nimbus Synergies led the round with participation from Nicola Wealth, Mint Venture Partners, Consortium Medteq, Wavemaker Three-Sixty Health, Gaingels, INP Capital and several angel investors. The round was oversubscribed by 150%. The hand-held Velacur system noninvasively quantifies liver volume, stiffness and attenuation, critical factors in diagnosing and monitoring liver disease in a process that takes about five minutes and can be performed in a physician’s office. The system received FDA clearance late last year.

Prelude Corp. (dba Preludedx) reported positive results from the SweDCIS randomized trial showing its DCISionrt test predicts radiation benefit for lowering 10-year local invasive breast cancer risk. The prognostic, artificial intelligence (AI)-based tool assesses and predicts the benefit of radiotherapy for women with ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS).

Due to COVID-19, diagnostics are in the limelight, and public and private investors are watching how the pandemic may impact the in vitro diagnostics (IVD) market in the future. As the sector receives an influx of investment, companies will be in strong positions to expand their portfolios. So, with 2022 around the corner – what are the investment trends to watch?

Nextsense Inc. reported partnerships with global biopharma company UCB SA, Heraus Holding GmbH, the University of California San Diego and Emory University at its first public appearance at the American Epilepsy Society Annual Meeting in Chicago this past weekend. The Nextsense platform uses biosensing earbuds to perform ongoing electroencephalograms (EEGs).

Israeli startup Ophthalmic Sciences Ltd. is targeting 2023 for regulatory clearance of its artificial intelligence (AI)-based contactless intraocular pressure (IOP) measuring device, IO Perfect. The technology, which combines AI visual analysis in a virtual reality headset, enables remote monitoring of glaucoma. The device is designed to be used at home, in eye clinics, emergency room departments, pharmacies and primary physician settings.

The Royal Academy of Engineering in the U.K. has selected 15 entrepreneurs from seven different countries for the latest edition of its Leaders in Innovation Fellowships Advance (LIF Advance) program, including some that offer med-tech solutions.

With large amounts of cash in hand from exponentially higher sales related to COVID-19, some Chinese med-tech companies are now implementing plans to continue growing in a post-pandemic world.

The emergence of the Omicron variant of the SARS-CoV-2 virus has sparked a vigorous reaction around the globe, which in the U.S. includes steps taken by the Biden administration to ensure that the roughly 100 million people who have received an initial vaccination regime will receive a booster if eligible. The administration also reported Dec. 2 that it will take steps to ensure that home testing will be covered by private payers, all of which amounts to a massive boost in business for manufacturers of vaccines and tests despite concerns about how the Omicron variant might affect vaccine and test performance.