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
Flexitouch® and Nimbl. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Flexitouch® Plus FDA Regulatory Events
Flexitouch® Plus is a drug developed by Tactile Systems Technology for the following indication: for treating patients with head and neck cancer-related lymphedema.
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:
- Flexitouch® Plus
- Announced Date:
- October 28, 2025
- Indication:
- for treating patients with head and neck cancer-related lymphedema.
Announcement
Tactile Systems Technology, Inc. announced the presentation of new six-month clinical data during the late-breaking poster session at the American Congress of Rehabilitation Medicine (ACRM) 102nd Annual Fall Conference demonstrating sustained clinical benefits of Flexitouch® Plus as a first-line therapy for treating patients with head and neck cancer-related lymphedema.
AI Summary
Tactile Systems Technology, Inc. announced new six-month clinical data at the American Congress of Rehabilitation Medicine 102nd Annual Fall Conference showing sustained benefits of its Flexitouch® Plus as a first-line therapy for head and neck cancer-related lymphedema. The large randomized controlled trial compared advanced pneumatic compression with usual therapist-guided care.
Results showed reduced internal swelling at 13 of 19 anatomical sites with Flexitouch Plus, including significant improvement at the base of tongue (p=0.008) and arytenoids (p=0.023). Clinician-reported measures of internal and external swelling also favored Flexitouch Plus, while both groups maintained symptom improvement over six months.
Dr. Sheila Ridner of Vanderbilt University highlighted that these are the first long-term data supporting pneumatic compression as an alternative to usual care for a population where up to 90% develop lymphedema within a year of cancer treatment. Tactile Medical’s CEO Sheri Dodd stressed the need to update clinical guidelines and payer policies to improve patient access.
Flexitouch Plus is an FDA-cleared at-home therapy for lymphedema and related chronic conditions.
Read Announcement
Nimbl FDA Regulatory 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
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