Featured Expert: Soumya Mahapathra, CEO, Essenvia Naysayers are everywhere and if you’re not careful they can ultimately keep your medical device company from spreading its wings. Below are just a few myths and misconceptions I’ve heard by people who claim Regulatory Information Management (RIM) platforms used to manage MedTech regulatory workflows...

EXECUTIVE SUMMARY: As medical technology companies move their products and services 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. This article, which emerged from...

The US healthcare system stands at a pivotal crossroads, with the potential for transformative change within reach. By simplifying care journeys, embracing telehealth, harnessing the power of automation and robotics, promoting quality care transparency, and personalizing care delivery, we can create a more efficient, accessible, and patient-centered...

The healthcare industry is a complex web of clinical, administrative, regulatory, and financial processes. Despite the advancements in health information technology and artificial intelligence, inefficiencies remain widespread. Success in the healthcare sector hinges on leveraging health information technology to streamline both clinical and administrative...

In a watershed moment for the diagnostic test industry, the Food and Drug Administration (FDA) this April issued a long-anticipated rule overhauling how Laboratory Developed Tests (LDTs) are regulated. The rule aligns LDTs’ regulatory framework with that of medical devices and details the agency’s rationale for removing enforcement discretion from most...

Activist investor 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. According to LSEG data, Cervian is known for taking stakes in companies and calling for change. In recent years, Smith & Nephew...