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BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia Mendaera pairs its handheld needle robot with Butterfly's ultrasound chip BTL clears EXOMIND for OCD and for depression in patients as young as 15 Medicare starts paying a new technology add-on for Cerapedics' P-15 bone graft Japan approves Novocure's Optune Pax for locally advanced pancreatic cancer SedMed raises $4M for a toilet lift that runs without power FDA names the first five companies in its READI-Home readmissions program Edwards wins FDA approval for a pulmonary valve that expands from 13 mm to 22 mm BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia Mendaera pairs its handheld needle robot with Butterfly's ultrasound chip BTL clears EXOMIND for OCD and for depression in patients as young as 15 Medicare starts paying a new technology add-on for Cerapedics' P-15 bone graft Japan approves Novocure's Optune Pax for locally advanced pancreatic cancer SedMed raises $4M for a toilet lift that runs without power FDA names the first five companies in its READI-Home readmissions program Edwards wins FDA approval for a pulmonary valve that expands from 13 mm to 22 mm

Japan

Japan approves Novocure's Optune Pax for locally advanced pancreatic cancer

MedDevice Startups Staff · 2 days ago · 2 min read · Via Novocure Form 8-K

Japan's Ministry of Health, Labour and Welfare approved Optune Pax on October 1 for adults with unresectable locally advanced pancreatic adenocarcinoma, used with gemcitabine and nab-paclitaxel as first-line treatment. Novocure disclosed the decision in a Form 8-K.

The file rests on the Phase 3 PANOVA-3 trial, which hit a statistically significant improvement in median overall survival. Device-related skin events reached 76.3 percent of treated patients, nearly all Grade 1 or 2, and serious adverse events were comparable between arms.

A 76 percent device-related adverse event rate reads badly on a slide and fine in an unresectable pancreatic cancer file, because the comparison is the survival curve and not a healthy-volunteer baseline. Sponsors building a tolerability argument for a wearable in oncology should look at how this one was framed.

Questions & Answers

What did Japan approve for Novocure's Optune Pax?

Japan's Ministry of Health, Labour and Welfare approved Novocure's Optune Pax on October 1, 2026 for adults with unresectable locally advanced pancreatic cancer, used together with gemcitabine and nab-paclitaxel as first-line treatment.

What did the Novocure PANOVA-3 trial show?

The Phase 3 PANOVA-3 trial showed a statistically significant improvement in median overall survival. Device-related skin adverse events occurred in 76.3 percent of treated patients, mostly Grade 1 or 2, and serious adverse events were comparable between arms.

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