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.
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.
Perkinelmer Inc. agreed to divest three businesses in a sale to private equity firm New Mountain Capital for $2.45 billion in cash to create a “pure-play, high growth, high margin life sciences and diagnostics company with unique scale,” said Perkinelmer president and CEO Prahlad Singh.
Cognetivity Neurosciences Ltd. is making progress in promoting its cognitive assessment tool as the brain health equivalent of a blood pressure check, following feedback from clinicians indicating the test could have broad applicability.
Big pharma is increasingly turning to Taiwan to leverage the power of the country’s data and computing power as precision medicine takes center stage in drug development, speakers said during the recent BIO Asia-Taiwan conference in Taipei.
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