The U.S. FDA recently released a guidance for non-invasive remote monitoring devices, which were granted tremendous leniency during the COVID-19 pandemic as a means of reducing the demands on hospitals and doctor’s offices. That policy has been extended for the non-COVID era as part of the agency’s strategic plan to improve health equity by ensuring that access to digital health technologies is enjoyed by diverse American populations in a variety of health care access-challenged geographical areas.
Burning Rock Biotech Ltd. wants to significantly change the way cancers are detected and the biotech is sailing ahead with the latest breakthrough device designation received from China’s NMPA for its multi-cancer detection blood test (MCDBT), Overc.
Celero Systems Inc. reported details of a patent filing for gastric residency systems for its ingestible devices, in the form a plurality of retention arms with non-deployed and deployed states sized and configured to temporarily retain the ingestible devices in the stomach for periods of up to a week.
An artificial intelligence (AI) algorithm using voice technology developed by Klick Inc. could be a game changer for diagnosis of type 2 diabetes, helping to identify the 50% of individuals who unknowingly have the disease. The technology uses a six- to 10-second voice clip spoken into a smartphone plus basic health data to detect diabetes in close to nine out of 10 individuals, a study published in Mayo Clinic Proceedings: Digital Health found.
In a new report from the U.S. International Trade Commission (USITC), concerns about global inequities accessing diagnostics and medicines for COVID-19 reveal that there are varied and divergent opinions on whether the intellectual property (IP) protections that support the development of new medicines may also act as a barrier to access, particularly in developing countries. In December 2022, U.S. Trade Representative Katherine Tai asked the USITC to respond and identify significant data and information gaps.
Geethanjali Radhakrishnan, founder and managing director of Chennai, India-based Adiuvo Diagnostics Pvt. Ltd. reported filing for patent protection for a digital assistant for wound triaging and treatment recommendations.
Scientists at Washington University in St. Louis reported filing patent protection for their breath test that quickly identifies those infected with SARS-CoV-2, requires only one or two breaths to be performed, and provides results in less than a minute.
The recent greenlight from European regulators to Tasso Inc. to market its Tasso+ device in the EU brings another solution to the market for blood collection Tasso has developed the Tasso+, a single-use blood lancing device that collects a microliter capillary blood from the upper arm. Tasso claims that it is the first device of its kind to get both CE mark and U.S. FDA approval.
The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual worldwide revenue.
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