The U.S. Food and Drug Administration approved the first autonomous artificial intelligence diagnostic system, IDx-DR and the University of Iowa Healthcare has become the first healthcare organization to implement it.
A new clinical trial executed under lead investigator, Professor Chris Hollis from the University of Nottingham in the UK, revealed that by adding a computerized test of attention and activity (QbTest) to standard subjective assessments, the clinicians could easily make a diagnostic decision on ADHD, with proper accuracy.
IDx, a privately held AI diagnostics company, announced today that it has filed its De Novo submission to the FDA for IDx-DR, an AI-based system for the autonomous detection of diabetic retinopathy — a leading cause of blindness. The FDA has granted IDx-DR with a “Breakthrough Device” designation, which means the submission will receive expedited review.
Illumina, Inc. (Nasdaq: ILMN) and Loxo Oncology (Nasdaq: LOXO) today announced a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication.
Panelists at the recent J.P. Morgan Healthcare Conference in San Francisco, CA were charged with separating the hype from the reality in the field of diagnostics and offered insight into what products will win in the space.
TAI Diagnostics, Inc., focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, announced the final closing of a $10 million Series A preferred equity financing. The company has now raised over $21 million since its inception. The proceeds of this financing will support on-going research and development of TAI’s innovative cell-free DNA (cfDNA) transplant monitoring technology, clinical studies, and the upcoming commercial launch of its post-transplant monitoring assays performed by its CLIA and CAP accredited reference laboratory.
Pfizer has collaborated with Foundation Medicine for the development of companion diagnostics (CDx) for its oncology portfolio.
Alveo Technologies, Inc., ("Alveo" or "the Company") whose mission it is to create affordable and accessible infectious disease diagnostic devices, announced the closing of a $38 million Series A financing raised by Maxim Merchant Capital, a division of Maxim Group LLC. The round was oversubscribed and included existing and new investors. The offering proceeds will be used to advance the optimization and commercialization of Alveo's rapid diagnostic platform for infectious diseases.
US-based gene sequencing firm Illumina has signed an agreement with Guangzhou KingMed Diagnostics Group to co-develop new oncology and hereditary disease testing applications in China.
The overall market value of in vitro diagnostics (IVD) stands at $52 billion this year, and is projected to grow at a compound annual growth rate (CAGR) of 4.2% to $69 billion in 2024. According to GlobalData, a leading data and analytics company.
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