News
Artera hits US first with pathology-based breast cancer risk tool's clearance
1+ hour, 15+ min ago (275+ words) Artera AI Breast is designed to stratify breast cancer patients into high- and low-risk groups to guide treatment decisions. Artera has obtained US Food and Drug Administration (FDA) clearance for Artera AI Breast, making it the first digital pathology'based risk…...
DDW 2026: key readouts from the conference
23+ hour, 43+ min ago (952+ words) Medical Device Network rounds up the key readouts from the 2026 Digestive Disease Week conference held in Chicago. At the 2026 Digestive Disease Week (DDW) conference, there was significant buzz around certain pharma and medical device readouts, with key results spanning across…...
Italy's new EFS Guidelines: why Europe's medtech innovation map just changed
2+ day, 3+ hour ago (434+ words) Giuseppe Aminzade, head of regulatory life sciences in Bonelli Erede's Healthcare & Life Sciences Focus Team, reflects on Italy's new early feasibility studies guidelines for medical devices. An EFS, under this framework, is a clinical investigation conducted during the early stages…...
Claire OCT System, US
5+ day, 5+ hour ago (737+ words) The Claire" OCT System is designed to assist surgeons in identifying hard-to-detect cancer during breast-conserving procedures. Perimeter Medical Imaging AI Approved in the US The Claire" OCT System, previously known as the Perimeter Optical Coherence Tomography (OCT) B-Series with Img…...
MUSC and Revival Healthcare to advance medical technologies
1+ week, 1+ hour ago (269+ words) The Medical University of South Carolina (MUSC) in the US and Revival Healthcare Capital have entered a five-year partnership aimed at advancing the clinical development of medical technologies. The agreement outlines plans for both organisations to collaborate on the assessment…...
Merck KGa A and Remepy join forces to develop combo drug-digital therapies
1+ week, 2+ day ago (551+ words) Merck KGa A has inked a collaboration deal with Israeli-US startup, Remepy, to explore the therapeutic potential of combination drug and app-based approaches in rare oncology " marking the first big pharma foray into this new evolving area for digital therapies....
Nervonik closes $52. 5m Series B funding to advance PNS system
1+ week, 2+ day ago (228+ words) The funds will support further development of Nervonik's sensing technology and commercialisation of its PNS platform. US-based medical device company Nervonik has secured $52. 5m in Series B financing aimed at advancing its peripheral nerve stimulation (PNS) system. Amzak Health led the…...
GE and Deep Health expand partnership for breast screening solutions
2+ week, 6+ day ago (247+ words) The agreement builds upon a 2024 collaboration integrating Deep Health's AI workflow with GE Health Care's Senographe system. GE Health Care has expanded its partnership with Rad Net subsidiary Deep Health to broaden access to AI-powered breast cancer screening solutions. The…...
FDA and CMS outline new Medicare coverage pathway for medical device access
1+ week, 6+ day ago (386+ words) The agencies" initiative is intended to speed up the processes involved in medical devices" securing Medicare coverage once approved by the FDA. The US Centers for Medicare & Medicaid Services (CMS) and the US Food and Drug Administration (FDA) have introduced…...
Acuity MD raises $80m for AI augmentation to medtech sales platform
2+ week, 1+ day ago (320+ words) Acuity MD plans to use AI to further advance its foundational platform designed for streamlining commercial execution protocols for medtech companies. Acuity MD has raised $80m to advance its provision for assisting medtech companies in accelerating the adoption of their products…...