Diagnostics
During an ECRI-hosted webinar on AI-enabled diagnostics, a panel of experts discussed the promise and risks that come with the technology for both physicians and patients alike.
Numares Health bets on a metabolomics-based urine test to help doctors detect kidney transplantation rejection earlier than current biomarkers, which would allow doctors to intervene earlier in trying to save the transplanted organ.
As AI becomes ubiquitous in diagnosing diseases, clinicians must balance the technology’s enormous upside, such as improving the speed and accuracy of diagnoses, with the potential for errors that can lead to delayed or missed treatment.
HeartBeam’s CEO says the strength of clinical data convinced the US FDA to reverse course and grant clearance to his company’s innovative ECG device, which he says can assess arrhythmias at home with hospital accuracy.
Curve Biosciences is developing a technology that analyzes signals from blood and organs to monitor the progression of chronic disease. The first product is a blood test to monitor patients with liver cirrhosis at risk for liver cancer, the second for MASH.
NVision is pursuing regulatory clearance in the US, with trials launching across the US, Europe and Asia. In Europe, it is starting with Germany, Denmark, the UK and Italy before seeking broader EMA approval.
Cognito Therapeutics closed a new funding round to advance its Alzheimer’s headset toward FDA De Novo submission and planned 2027 launch while expanding its Brain Health Collaboratory to support adoption, reimbursement innovation, and pipeline growth.
Nutromics’ wearable microneedle patch seeks to provide continuous drug monitoring in acute care patients starting with the hard-to-dose antibiotic vancomycin.
CMS is asking stakeholders to help the agency craft potential regulatory changes aimed at bolstering its efforts to combat Medicare and Medicaid fraud. The agency has provided several topics to help guide stakeholder engagement.
The US FDA has a new digital health head in radiologist Rick Abramson, an AI-industry veteran who is now director of the Digital Health Center of Excellence. Abramson has been an FDA adviser since last summer.
After a steep drop in 2025, women’s health investment is expected to rebound in 2026, driven by renewed focus on menopause, certain chronic conditions and mental health, as well as a shift toward clinically validated products.
The US FDA says incorrect code messages from some Trividia glucose measurement devices could result in delayed treatment and serious patient harm.
After nearly 30 years at NASA, Omar Hatamleh prepares for his next chapter and fourth book on AI. He told Medtech Insight AI will speed up medical breakthroughs, extend life spans and bring AGI sooner than expected but also drive job losses, erode privacy and force humans to rethink their purpose.
The US FDA hosted a virtual town hall as a follow-up to final guidance the agency issued last month, which outlines its policy on general wellness medical devices that the agency considers low risk.
The US FDA has warned that Magellan Diagnostics blood lead tests may provide inaccurately high results, particularly with tubes from ASP Global. Magellan’s tests had previously been recalled over inaccurate low results. The FDA also issued warning letters to both firms.
The US FDA has granted clearance to eMurmur, broadening the use of its AI-powered software platform. The innovative system identifies primary heart sounds to detect abnormal murmurs as they occur.
Molecular diagnostics firm SAGA Diagnostics has introduced a colorectal cancer test that can detect even very low levels of cancer biomarkers. The test helps clinicians guide post-surgical treatment decisions.
The US FDA has published a draft guidance on clinical performance testing and evaluation for premarket submissions from manufacturers of cuffless blood pressure measuring monitors, which the agency generally regulates as class II devices.
Abbott started 2026 as it ended 2025 – with major regulatory breakthroughs for pulsed field ablation innovations, boosting its EP credentials in the US and EU. It also broadened its IVDs platform by adding cancer detection and screening company Exact Sciences in a deal expected to close in Q2.
The US FDA has sent warning letters to four companies that it says distribute HIV sample collection kits for home use without proper regulatory authorization.