A recently published study demonstrated that Viome Life Science Inc.’s metatranscriptomic signature for oral cancer identified the malignancy from samples of saliva with more than 90% accuracy. The mRNA platform received breakthrough device designation from the FDA in May for both early-stage oral squamous cell carcinoma and oropharyngeal cancer.

TORONTO – Hyperfine Inc. has received Health Canada approval for the first FDA-cleared portable magnetic resonance imaging (MRI) device, which also features advanced reconstruction deep learning software. The company simultaneously announced its commercial launch of the Swoop imaging system in Canada.

This year saw continued advances in smartwatches as they increasingly move from wellness assistants to medical monitors. Nowhere has that been clearer than in cardiovascular health, where multiple wearables now allow users to quickly detect atrial fibrillation, a notoriously shy condition previously only detectable in early stages by chance in a physician’s office or by wearing a cumbersome Holter monitor for 24 to 48 hours.

PARIS – Dyameo SAS has successfully raised $1.13 million in seed funding to develop its endoscopy probe used for the instantaneous detection of cancerous cells. This round was led by  Medevice SAS and Aquiti Gestion SAS via its co-investment fund, NACO.

Depixus Ltd. has raised $35.4 million in an oversubscribed series A financing to push commercialization of its Magna multiomics system. The series A round was co-led by Lansdowne Partners and PSIM Fund, with participation from Casdin Capital and existing investor Arix Bioscience. The funds bring the company's total equity and grant funding to more than $47 million.

LONDON – Lifelight Ltd. is preparing for a new funding round in the first quarter of 2022 after making significant headway with its contactless technology for monitoring vital signs, as push came to shove during the pandemic and remote patient monitoring became a necessity.

The European Investment Bank (EIB) is continuing a streak of investments in the med-tech space, signing a €20 million (US$22 million) loan agreement with Midiagnostics NV, to scale-up a new rapid COVID-19 PCR test. Leuven, Belgium-based Midiagnostics is developing a rapid PCR test for SARS-CoV-2, which can achieve an accuracy speed 20 times faster than classic PCR machines. A nasopharyngeal swab sample is transferred on a PCR testcard, from which the results are read by a compact reader. Pilot programs for the test began at Brussels Airport this month, with a market launch pegged for Spring 2022.

The controversial approval of Biogen Inc.’s Aduhelm (aducanumab) in June sharply increased the interest in developing a quick, painless method of diagnosing Alzheimer’s disease (AD). Now, more than half a dozen blood-based diagnostic assays are in development and one is commercially available, albeit without FDA clearance.

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.