The approval of the Ranger paclitaxel-coated balloon makes Boston Scientific the only company offering both a drug-eluting stent and drug-coated balloon for treating peripheral artery disease in the US.
The US Food and Drug Administration approvedBoston Scientific’s Ranger drug-coated balloon for the treatment of peripheral artery disease in the superficial femoral artery and proximal popliteal artery.
The company announced on 2 November that it plans to immediately launch Ranger in the US. Ranger earned a CE...
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.
Modifying or doing away with the EU medtech recertification requirement is far from straightforward. Four experts from an EU national authority, an EU notified body trade association and industry, plus a well-known medtech consultant, reflect on how to move forward.
