The Oncodetect test is tumor-informed, tracking up to 200 circulating tumor DNA (ctDNA) variants. It delivers simple “detected” or “not detected” results alongside quantitative data to guide adjuvant therapy decisions, monitor treatment response, and detects up to 200 ctDNA variants identifying signs of colorectal cancer recurrence up to two years earlier than imaging.
Exact Sciences has officially entered the molecular residual disease (MRD) testing market with the launch of Oncodetect, expanding its precision...
While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.
In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
