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.
A subfield of AI aims to explain why complex models make predictions, which will increase their interpretability and auditing ability, AI researcher Su-In Lee said during a National Academies of Sciences workshop.
Abbott will acquire Exact Sciences for $21bn, which marks the largest such deal ever in the diagnostics space. The deal will allow Abbott to enter the fast-growing $60bn US cancer screening market.
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.
The prosthetics market is evolving due to an increase in amputees from war and disease. Unhindr has developed a novel prostetic liner that can reduce the risk of further injury, while Esper is crafting advanced hand implants for Ukraine's front-line soldiers.
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.
The neuromodulation space is quickly filling with well-funded companies that have demonstrated early signs of success. However, with strategics seemingly unwilling to spend on novel technologies and pharma desperate to maintain its foothold in CNS, these companies will face many challenges.
Wearables innovator Oura has launched a profile study aimed at helping the company secure FDA clearance for a blood pressure feature for its smart ring. Study participants will answer questions while wearing the ring, which the company plans to use to support the feature’s efficacy.
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.