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Tactile Medical lifts 2026 EBITDA guidance as LymphaTech scanner gains wider FDA clearance

🇺🇸 Tactile Systems Technology Inc (TCMD) · Mon 02 Nov 2026

The lymphedema device maker reported third-quarter revenue of $91.9 million, announced an expanded 510(k) clearance and filed a new 510(k) for Flexitouch Pro.

Tactile Systems Technology, trading as Tactile Medical (Nasdaq: TCMD), published its results for the quarter ended 30 September 2026 on 2 November. Revenue rose 7% to $91.9 million, while net income fell to $7.2 million.

The company's headline title also points to a 13% rise in lymphedema sales. No further breakdown of segments or product lines was available to VigiEye at the time of writing.

On the regulatory side, Tactile said the US Food and Drug Administration has cleared a 510(k) that widens the indication for its LymphaTech 3D Scanner in lymphedema assessment. The company also said it has submitted a 510(k) for Flexitouch Pro. The filing's scope and any expected decision timeline were not stated in the material reviewed.

Tactile raised its 2026 Adjusted EBITDA guidance to a range of $50 million to $52 million. The previous range was not given in the material available.

What it means for your team

  • Regulatory teams tracking lymphedema devices should note the expanded LymphaTech 3D Scanner indication and the pending Flexitouch Pro 510(k). A 510(k) is a US premarket notification in which a manufacturer shows a device is substantially equivalent to a legally marketed predicate.
  • The Flexitouch Pro submission has no stated decision date, so any commercial or labelling impact remains unconfirmed until the FDA acts.
  • Market-access teams may want to read the full results release for details on the lymphedema growth drivers, which the material reviewed did not provide.

Company's press release (SEC filing): Tactile Systems Technology Inc ↗

Article written by VigiEye from the official source (Tactile Systems Technology Inc). Claims are the company's own. AI-assisted; check the source before acting.

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