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THE TAPE

FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel CraniUS clears a patient-specific cranial plate under K261058 Ropca clears its arthritis ultrasound robot for the US after four years in Europe Petal Surgical shows its histotripsy robot and says first-in-human is close FDA says it has never authorized a clear aligner sold without a prescription LUMA Vision clears a second VERAFEYE 510(k), adding catheter tracking and ablation marking FDA approves Abbott's TactiFlex Duo, one catheter that switches between pulsed field and RF Boston Scientific tells the SEC it will miss 2026 guidance after the August cyberattack Bioretec clears a headless bioabsorbable compression screw for hand and foot fixation FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel CraniUS clears a patient-specific cranial plate under K261058 Ropca clears its arthritis ultrasound robot for the US after four years in Europe Petal Surgical shows its histotripsy robot and says first-in-human is close FDA says it has never authorized a clear aligner sold without a prescription LUMA Vision clears a second VERAFEYE 510(k), adding catheter tracking and ablation marking FDA approves Abbott's TactiFlex Duo, one catheter that switches between pulsed field and RF Boston Scientific tells the SEC it will miss 2026 guidance after the August cyberattack Bioretec clears a headless bioabsorbable compression screw for hand and foot fixation

Commercial launch

Zenflow says four US centers have run the first commercial Spring cases

MedDevice Startups Staff · 3 days ago · 2 min read · Via Zenflow release (GlobeNewswire)

Zenflow said four US centers have now completed commercial procedures with the Spring implant. Sijo Parekattil did the first on July 29, 2026 at Avant Concierge Urology in Winter Garden, Florida. FDA approved the South San Francisco company's PMA in December 2025.

The other three: Bilal Chughtai at the Smith Institute of Urology at Northwell Health's Plainview Hospital, Mohamed Bidair at Alvarado La Mesa Urology, and Austen Slade at Dr. Slade Urology in Boise. The Spring goes in through a single-use flexible cystoscope, comes in three sizes, needs no catheter afterward and can be removed.

Seven months from approval to first commercial case is a deliberate pace, and four sites in six weeks after that is a controlled launch rather than a ramp. For a first-line BPH device that has to win office urologists, which four proctors go first will matter more than the count does.

Questions & Answers

How many centers have implanted the Zenflow Spring commercially?

Zenflow said on September 8, 2026 that four US centers had completed commercial procedures with the Zenflow Spring implant and delivery system. The first was performed July 29, 2026 by Sijo Parekattil at Avant Concierge Urology in Winter Garden, Florida.

What is the Zenflow Spring implant?

The Zenflow Spring is a minimally invasive first-line interventional therapy for benign prostatic hyperplasia from Zenflow of South San Francisco. It is delivered through a single-use flexible cystoscope, comes in three sizes, is removable and requires no catheter after the procedure.

When did FDA approve the Zenflow Spring?

FDA approved the Zenflow Spring implant and delivery system in December 2025 as a first-line interventional therapy for benign prostatic hyperplasia. The first commercial case followed on July 29, 2026.

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