Clinical Trials
Paradromics won FDA clearance to test its Connexus BCI in two people with severe speech impairment. The 2026 trial will assess whether the device can decode speech in real time.
US healthcare innovation agency ARPA-H has announced a $100m initiative focused on building up the evidence base for fast-acting mental health treatments such as neuromodulation and digital therapeutics. The project is the first major initiative to be led by new ARPA-H director Alicia Jackson.
Medtech Insight spoke with Rambam Medical Center’s Michael Mimouni, who implanted the first 3D-bioprinted corneal graft in a human patient, about his hopes for Precise Bio’s approach. The patient is part of a Phase I trial evaluating PB-001 in patients with corneal edema.
BrainsWay advanced its Deep TMS platform with an FDA labeling expansion for adolescent MDD and the launch of a 200-patient alcohol use disorder trial. The company posted strong Q3 growth and is pursuing new indications and at-home neuromodulation through its Neuralief investment.
Data from Medicare patients shows no increased death risk for peripheral arterial disease patients treated with drug-coated devices, easing concerns that once led FDA to discourage use of the products. Researchers say the study could be a model for future large-scale cardiac device safety trials.
Neurotech start-up Subsense started proof-of-concept studies in mice hoping to show by late 2026 that its nonsurgical, nanoparticle-driven brain-computer interface can read and stimulate neural activity and treat conditions such as Parkinson’s and epilepsy.
INBRAIN teamed up with Microsoft to apply agentic AI to analyze real-time brain data and eventually recommend programming like a “mini-neurologist,” said CEO Carolina Aguilar. It also seeks to enable scalable deployment of INBRAIN’s graphene-based technology and potential joined research.
Synchron raised $200m in series D funding to support pivotal trials in 2026 as well as commercialization of its Stentrode BCI. It also announced plans for a next-gen high-channel whole-brain interface and a new engineering hub in San Diego.
Nearly one year into leading their agencies, US FDA Commission Marty Makary and CMS Administrator Mehmet Oz took to the stage together at the Milken Institute’s Future of Health Summit 2025 to highlight what they see as progress and lay out plans for the road ahead.
Advocates spanning the spectrum of women’s health met in Manhattan to discuss the gender disparities that remain in healthcare and how public policy can correct them and the enormous ROI investors in women’s health can potentially reap.
Delfi Diagnostics is preparing for pivotal trial results that could support FDA approval and reimbursement for its fragmentomics-based lung cancer screening test. Early data suggest strong potential to improve screening uptake and expand access to early detection.
GT Medical says interim results from a clinical trial studying an innovative surgical procedure to treat brain tumors show promise for patients with newly diagnosed operable brain metastases.
The $250m in new funding from HistoSonics’ new owners and new investors Thiel Bio and Founders Fund will expand its histotripsy platform globally, advance new indications, and scale operations. CEO Mike Blue tells Medtech Insight that an IPO isn’t an immediate priority.
Evidence-based testing in real clinical settings and diagnostics tailored to community needs are crucial adoption success factors for new IVDs, Michael Wright, joint medical director at Newcastle Hospitals NHS Foundation Trust, told Medtech Insight at a regional UK meeting.
Armor Medical’s wrist-worn wearable detected postpartum hemorrhage five times earlier than standard care in earlier studies. After surviving near-fatal hemorrhage herself, co-founder/CEO Kelsey Mayo aims to bring the device to market in 2028.
Excitement surrounds Multi Cancer Early Detection testing for diagnosing hard-to-detect cancers early and improving patient outcomes. But without full randomized trials – only accuracy studies – physicians lack enough evidence to use them confidently, said physician and researcher Daniel Jonas.
Successful implantations of a novel transcatheter mark a major step forward in treating congestion in heart failure, according to the California-based company that developed it. The procedure was part of a feasibility study evaluating the device’s safety.
Resitu Medical has received FDA 510(k) authorization for the RESL09 breast cancer biopsy device. This handheld minimally invasive device excises tissue samples with diameters up to 9 mm and will first reach market in the US. The company plans to expand the tool’s clinical claims and core size range.
Rapid Nexus hopes its regenerative wound-healing system can ease the burden of diabetic foot ulcers and amputations. Backed by early clinical data and $3.8m in seed funding, the start-up is targeting the VA as a launchpad into a $6.5bn US market, with FDA clearance expected later this year.
The Nancy Gardner Sewell MCED Act has advanced in the US House, potentially allowing Medicare coverage for multi-cancer early detection tests. Exact Sciences is targeting FDA approval for its MCED test Cancerguard, launched in the US earlier this month.