Shanghai Aitrox Technology Co. Ltd. (Fosun Aitrox) completed strategic financing of over ¥100 million (US$14.8 million) to develop its pipelines in artificial intelligence (AI)-aided diagnosis platforms. This financing was led by Shanghai Fosun Pharmaceutical (Group) Co. Ltd. and Sinopharm-CICC (Shanghai) Private Equity Investment Management Co. Ltd.
Syncthink Inc. is preparing to launch its neurological impairment and disease diagnostic in Europe, after securing CE marking for the ocular biomarker device. The company is raising a new round of funding to support commercialization of the Eye-Sync system and has two projects exemplifying applications of the device running with academic collaborators in the U.K.
Dartmouth College spinoff Nanopath Inc. closed a $10 million series A funding round to commercialize a point-of-care biosensing platform with ultrasensitive optical detection. The startup is developing a rapid test that provides genetic information in less than 15 minutes without the need for nucleic amplification. To date, the company has generated preliminary data in two clinical indications focused on women’s health: human papillomavirus genotyping and urinary tract infection characterization.
Intravascular ultrasound (IVUS) is an established method for gaining an appreciation of the sources of closure of the coronary arteries, but its use in the peripheral vasculature is not quite as well established. Nonetheless a new paper makes the case that IVUS may be appropriate for widespread use in connection with diseases of the peripheral vasculature, a position that could lead to a considerable expansion of sales of IVUS systems.
Recent U.S. FDA actions could transform decades of prostate cancer care. Two companies focused on prostate cancer received good news from the FDA for their artificial intelligence (AI)-driven software. Bot Image Inc. gained FDA clearance for its medical device computer-aided detection and diagnostic tool, Prostatid. The agency also provided FDA investigational device exemption for Avenda Health Inc.’s Focalpoint ablation system that enables more accurate mapping of a patient’s prostate cancer for better surgical results.
The U.S. FDA granted digital therapeutics company Bodyport Inc. 510(k) clearance for its heart monitoring weight scale. The digital solution includes sensors and algorithms that measure hemodynamic biomarkers to assess heart function and fluid status when patients take their daily weight. San Francisco-based Bodyport told BioWorld the platform is for heart failure (HF) patients in the U.S.
The largest study to date assessing the use of cell-free DNA (cfDNA) analysis to detect cancer in advance of symptoms has completed enrollment of 140,000 healthy volunteers. The study, being run in the U.K. National Health Service (NHS) by the charity Cancer Research UK (CRUK) and cfDNA diagnostics specialist Grail Inc., is using Grail’s Galleri test to look for cancer-specific methylation patterns in blood.
Data on C2N Diagnostic LLC’s new blood test combining a proprietary p-tau217 measurement with the amyloid beta (a-beta) 42/40 ratio, a component of C2N’s commercially available PrecivityAD blood test, could help to predict people at risk for Alzheimer’s disease (AD) – even at the earliest stages.
Epigenetic test company Volitionrx Ltd. appointed contract research organization (CRO) Diagnostic Oncology CRO LLC (DXOCRO) to conduct development and clinical validation studies for its Nu.Q product portfolio in the U.S. DXOCRO will carry out large-scale finding studies across the U.S. using Henderson, Nev.-based Volition's cancer tests to determine clinical utility in sepsis and cancer. The trials are aimed at U.S. FDA approval of the products.
No one denies that fewer new drugs will be a consequence of the Medicare drug pricing provisions the Democrats are trying to push through the U.S. Congress ahead of the midterm election campaign season. Less attention has been paid to the negative impact on drug-device combinations and new diagnostics that accompany innovative treatments.
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