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.

Fist Assist Devices LLC received a breakthrough device designation from the FDA for its Fist Assist Model FA-1 device for patients with end-stage renal disease (ESRD). The pre-surgical dilation device promotes arteriovenous (AV) fistula creation in renal failure patients with inadequate vein size for creation of an AV fistula for hemodialysis. An AV fistula is a surgical connection between an artery and a vein used as an access point for dialysis.

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.

Xandar Kardian Inc. closed a $10 million series A funding round to support the rollout of the company’s contactless health monitoring solution. Phoenix Venture Partners led the round with participation from Portfolia Active Aging & Longevity Fund, Taronga Ventures and others. “With the new financing round, Xandar Kardian looks forward to expanding its core team in Toronto and in the United States, in addition to placing increased emphasis on R&D and mass production for its technologies,” Xandar Kardian co-founder and CEO Sam Yang told BioWorld.

Intervene Inc. received breakthrough device designation from the FDA for its treatment for chronic venous insufficiency (CVI), Blueleaf endovenous valve formation system, which makes new venous valves in the leg using the patient’s own vein tissue. The catheter-based system splits and stretches the vein wall to create a new leaflet. In a recently published study, 14 patients underwent the procedure, of which 13 successfully had at least one new valve created. No patients experienced adverse events during the procedure and no deep venous thromboses developed through a one-year follow up period.

Becton, Dickinson and Co. (BD) reported it acquired Tissuemed Ltd., maker of the self-adhesive Tissuepatch surgical sealant. The terms of the deal were not disclosed. The transaction is not expected to have a material impact on BD’s fiscal 2022 financial results. Tissuemed reported 2020 revenues of £2.6 million (US$3.44 million) up from £1.7 million (US$1.32 million) in 2019 in a filing made in November 2020. Net profit was £1.06 million (US$1.40 million) up from £851,000 (US$1.124 million). BD has been on a purchasing binge in recent years with more than a dozen tuck-ins since the start of 2020.

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.

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.

Suki AI Inc. recorded $55 million in a series C fundraising round to support further development of its artificial intelligence (AI)-driven voice technology and digital clinical assistant for health care providers. The round was led by March Capital with participation by Philips Ventures. All previous investors in the company also returned, including Gaingels Group, Pankaj Patel (former chief development officer of Cisco), Andrew Deutsch (CEO of RIMA Radiology), and Russell Farscht (former managing director of The Carlyle Group).