PARIS – Biosynex SA signed a binding offer to acquire 100% of the stock in Avalun SAS, a company developing the Labpad in vitro diagnostic device that provides rapid biological test results from small sample volumes. In Europe, Avalun is currently marketing a follow-up test for patients on anticoagulation therapy using antivitamin K agents, and a test for automated antigen detection for COVID-19.
Veriskin Inc. has emerged from stealth mode with a noninvasive technology for skin cancer diagnosis and screening. The hand-held device, called Truscore, is designed to help nonexpert users quickly ascertain if a suspicious skin lesion is cancerous. Truscore works by detecting and interpreting force-induced hemodynamic differences between normal and malignant skin sores. It uses a proprietary artificial neural network-based artificial intelligence algorithm and protocols to differentiate skin cancers from other harmless skin conditions.
With the intense focus on developing COVID-19 diagnostics, sequencing tools, vaccines and treatments, the pandemic is having an outsized impact on the global development of drugs and devices to treat other diseases. Recent data show that more than 1,000 clinical trials worldwide remain disrupted by COVID-19, including 60% of the non-COVID-19 trials being conducted in the U.S., as funding and other resources continue to be directed toward ending the pandemic.
The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
Heru Inc. has raised $30 million in a series A financing to support the further development of its artificial intelligence (AI)-enabled, wearable eye diagnostic and vision correction platform. D1 Capital Partners led the round, with participation from Softbank Ventures Opportunity Fund, Maurice Ferre, Frederic Moll, Krillion Ventures and a consortium of investors with expertise in developing, launching and scaling medical technologies.
TORONTO – An initial investment of $250,000 by MCI Onehealth Technologies Inc. could just be the beginning for Ariel Precision Medicine Inc. and an artificial intelligence-fueled platform that uses genetic and clinical data to identify early symptoms of chronic disease.
PARIS – Tecmoled SAS has just completed the initial testing phase for its wireless oximeter. A prototype has been tested over the past four months on 30 healthy subjects, aged 2 to 70 years, to measure oxygen saturation (SpO₂), heart rate and body temperature.
PERTH, Australia – Australia’s budget theme for the 2021 to 2022 fiscal year is rebuilding the economy following COVID-19, and med-tech and biotech leaders were praising some of the new measures.
The FDA’s legal authority to regulate lab-developed tests (LDTs) has come into question on several occasions in a number of venues, and the issue is enjoying new life yet again thanks to more activity on Capitol Hill. While two competing pieces of legislation are back in play, the most critical question may be whether the FDA has any authority left at all after the August 2020 rescission letter from the Department of Health and Human Services.
Perkinelmer Inc. has agreed to acquire in vitro diagnostics company Immunodiagnostic Systems Holdings plc (IDS) for approximately $155 million (£110 million). The deal will enable Perkinelmer to expand its overall diagnostics business, particularly the immunodiagnostics segment. Based in Boldon, U.K., IDS makes chemiluminescence products in endocrinology, autoimmunity and infectious diseases. The company has three operating business units: Automated IVD Business, Manual IVD Business and Licensing and Technology.
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