As medical technology products and services move through the development pipeline, they face the challenge of both showing safety and efficacy for regulatory approval and articulating the value of the diagnostic, treatment or monitoring technology to obtain reimbursement from payers. A 2024 MedExec Women Conference panel highlighted strategies to bridge the evidence needs for regulatory approval and reimbursement to more efficiently bring products to market.
Cevian Capital increased its position in Smith & Nephew to a 5% stake in the British medical equipment maker, making it Smith & Nephew’s second largest shareholder according to reports by Reuters.
Nearly 2/3 of device makers say their regulatory intelligence may be insufficient and they lack the resources to complete all product compliance needs this year. See the executive summary of this MedTech Intelligence audience research.
An analysis from the Life Sciences legal team at Hogan Lovells.
Medical Device Original Equipment Manufacturers (OEMs) are increasingly seeking sophisticated thermal solutions to improve medical device performance. How does the transition from traditional heaters to advanced, layered heater technologies impacts device design?
North Carolina healthcare provider supplies clinicians with immediate, on-site access to 3D-printed anatomic models and support through Ricoh Managed Services.
Pager Health announces new technology and services for patients and members to engage with providers and care management teams, customer service, and others – all connected in a unified conversation.
Explore our EU MDR Checklist designed to help you navigate EU MDR compliance. This practical tool guides you through essential steps to adapt your processes and ensure documentation meets regulatory standards. Start your compliance journey with confidence.
Payers demand robust evidence that molecular diagnostics and AI/ML technologies demonstrate clear ability to improve overall patient health or healthcare economics even if the technologies themselves don’t directly deliver the final outcome. This disconnect between a technology’s function and the desired long-term impact creates a hurdle for [innovators] to overcome when convincing payers of their value proposition.
San Diego-based medical tech company, Cue Health, announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations.
