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THE TAPE

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

Launch

Emboline runs its first US commercial Emboliner cases at Columbia

MedDevice Startups Staff · 1 day ago · 2 min read · Via Emboline press release

Emboline said on October 2 that the first commercial Emboliner procedures in the US were performed at NewYork-Presbyterian/Columbia University Irving Medical Center by Tamim Nazif, co-director of the Structural Heart and Valve Center. FDA cleared the embolic protection system through a 510(k) in September 2026.

Emboliner captures debris during transcatheter aortic valve replacement. The study that supported clearance ran it head to head against Boston Scientific's Sentinel, the only other embolic protection device on the US market. Emboline is privately held and based in Santa Cruz, California.

Three weeks from clearance to first commercial case is fast for a structural heart device, and it usually means the account was built during the trial. Picking the enrolling site as the launch site is the cheapest commercial move available to a single-product company.

Questions & Answers

Where were the first US commercial Emboline Emboliner procedures performed?

The first US commercial Emboliner cases were done at NewYork-Presbyterian/Columbia University Irving Medical Center by Dr. Tamim Nazif, co-director of the Structural Heart and Valve Center. Emboline announced them on October 2, 2026.

What is the Emboline Emboliner Embolic Protection System?

Emboliner is a catheter-based system from Emboline that captures embolic debris during transcatheter aortic valve replacement. FDA cleared it through a 510(k) in September 2026.

Where is Emboline based?

Emboline is a privately held company based in Santa Cruz, California.

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