FDA Events for Tactile Systems Technology (TCMD)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Tactile Systems Technology (TCMD).
Over the past two years, Tactile Systems Technology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Nimbl. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Nimbl - FDA Regulatory Timeline and Events
Nimbl is a drug developed by Tactile Systems Technology for the following indication: Pneumatic compression platform.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Nimbl
- Announced Date:
- February 4, 2025
- Indication:
- Pneumatic compression platform
Announcement
Tactile Systems Technology announced that Nimbl, its next-generation pneumatic compression platform, is now commercially available throughout the United States (U.S.) for the treatment of both upper and lower extremity lymphedema.
AI Summary
Tactile Systems Technology has announced that its next-generation pneumatic compression platform, Nimbl, is now commercially available across the United States for treating lymphedema in both the upper and lower extremities. Initially launched in October 2024 for upper extremity lymphedema, Nimbl now addresses the needs of an estimated 16 million Americans who experience chronic swelling in the lower extremities.
The device is designed with patient convenience in mind. It is notably the smallest PCD of its kind, featuring a controller that is 68% lighter and 40% smaller than previous models and uses 94% less hosing. Additionally, Nimbl is the only basic pneumatic compression device with Bluetooth® connectivity, enabling patients to track their treatments and symptom progress through the free Kylee™ digital application.
Read Announcement- Drug:
- Nimbl
- Announced Date:
- September 16, 2024
- Indication:
- Pneumatic compression platform
Announcement
Tactile Systems Technology, announced that the Pricing, Data Analysis, and Coding (PDAC) contractor for the Centers for Medicare & Medicaid Services (CMS) has approved the use of Healthcare Common Procedure Coding System (HCPCS) code E0651 for billing the Durable Medical Equipment Medicare Administrative Contractors for Nimbl™, the Company's next-generation pneumatic compression platform.
AI Summary
Tactile Systems Technology announced that the Pricing, Data Analysis, and Coding (PDAC) contractor for CMS has approved the use of Healthcare Common Procedure Coding System (HCPCS) code E0651 for billing Durable Medical Equipment Medicare Administrative Contractors. This approval allows the company to bill for Nimbl™, its next-generation pneumatic compression platform designed to treat lymphedema, chronic edema, venous insufficiency, and to aid in wound healing. Nimbl features a lighter, smaller design that enhances portability and connects with Tactile’s Kylee™ digital application, helping patients track their therapy progress easily. With PDAC approval in hand, the company plans to make Nimbl commercially available in the United States in the coming weeks. This milestone is a significant step in providing Medicare beneficiaries with advanced and efficient treatment options for managing their chronic conditions.
Read Announcement
Tactile Systems Technology FDA Events - Frequently Asked Questions
As of now, Tactile Systems Technology (TCMD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Tactile Systems Technology (TCMD) has reported FDA regulatory activity for Nimbl.
The most recent FDA-related event for Tactile Systems Technology occurred on February 4, 2025, involving Nimbl. The update was categorized as "Provided Update," with the company reporting: "Tactile Systems Technology announced that Nimbl, its next-generation pneumatic compression platform, is now commercially available throughout the United States (U.S.) for the treatment of both upper and lower extremity lymphedema."
Currently, Tactile Systems Technology has one therapy (Nimbl) targeting the following condition: Pneumatic compression platform.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:TCMD) was last updated on 7/11/2025 by MarketBeat.com Staff
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