MedTech Strategist Market Pathways explores the people, challenges, and opportunities impacting the medtech regulatory and reimbursement community. Explore our coverage. Think Strategically. Subscribe Today.
China’s regulatory agency is doing more inspections at device facilities around the world, and National Medical Products Administration audits are logistically more complex than an FDA inspection. Here are survival tips from Vy Tran, who leads regulatory operations at Varian Medical Systems, which recently hosted NMPA auditors at its Palo Alto facility.
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At-home sleep apnea test firm Itamar Medical is making progress with payors, but has hit a barrier with Medicaid for its technology. It’s not an uncommon challenge, say experts, who discuss the challenges and offer advice for medical device innovators dealing with state Medicaid programs.
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Active Implants’ NUsurface Meniscus Implant is on an FDA regulatory pathway that is rarely traveled by orthopedics devices. It is pursuing a de novo classification and it has one of only two-ever Breakthrough Device designations given out to date by the FDA’s Orthopedic Branch.
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