Tactile Medical Receives FDA 510(k) Clearance for

New Post Public Reply Private Reply Replies (0) Message Board
News Desk 2018
465
Tactile Medical Receives FDA 510(k) Clearance for Flexitouch® Plus, with Improved Therapy for At-Home Lymphedema Treatment

MINNEAPOLIS, June 01, 2017 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (“Tactile Medical”) (Nasdaq: TCMD ), a medical technology company focused on developing medical devices for the treatment of chronic diseases at home, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Flexitouch Plus, the third-generation version of its Flexitouch system.

“We have listened to our customers’ suggestions on how we could make our Flexitouch system easier to use and have incorporated this important feedback into a new design to meet our patients’ needs and enhance their at-home treatment,” said Gerald R. Mattys, Chief Executive Officer of Tactile Medical. “In the Flexitouch Plus, we modified the Flexitouch controller and garments to improve the patient experience. We believe the result is an easier to use system that should drive even higher patient satisfaction with the same proven clinical outcomes of our Flexitouch system.”

Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. Lymphedema affects an estimated five million people in the United States. While there is no cure, Tactile Medical focuses on effectively relieving the condition’s symptoms, preventing symptoms from worsening and reducing the risk of skin damage and infection.

Tactile Medical intends to launch a limited market release of the Flexitouch Plus in late 2017, with a full market release expected in 2018.

About Tactile Medical

Tactile Medical is a leader in developing and marketing at-home therapy devices that treat lymphedema and chronic venous insufficiency. Our unique offering includes advanced, clinically proven pneumatic compression devices, as well as continuity of care services provided by a national network of product specialists and trainers, reimbursement experts, patient advocates, and clinical staff. This combination of products and services ensures that tens of thousands of patients annually receive the at-home treatment necessary to better manage their chronic conditions. Tactile Medical takes pride in the fact that our solutions help increase clinical efficacy, reduce overall healthcare costs and improve the quality of life for patients with chronic conditions.

Legal Notice Regarding Forward-Looking Statements:

This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of the Company’s control that can make such statements untrue, including, but not limited to, the adequacy of the Company’s liquidity to pursue its complete business objectives; the Company’s ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives; adverse economic conditions or intense competition; loss of a key supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Company’s products; technical problems with the Company’s research and products; the Company’s ability to expand its business through strategic acquisitions; the Company’s ability to integrate acquisitions and related businesses; price increases for supplies and components; and the inability to carry out research, development and commercialization plans. In addition, other factors that could cause actual results to differ materially are discussed in the Company’s filings with the SEC, including the final prospectus for the Company’s initial public offering. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Scroll down for more posts ▼

Top 10 Most Recent News Articles

AI Stocks Surge Despite Boardroom Woes and Security Probe

Updated Category News Views 31

The Boardroom Drama Versus Business Reality Who knew that board stuff could stir up as much interest as a blockbuster earnings report? But here we are, with NVIDIA Corporation (NASDAQ: NVDA) at the center of a boardroom spectacle that's enough to make some investors sweat bullets. Turns out, CEO Jensen Huang is reportedly tangled up in a foreign intelligence effort...

Continue Reading
Olympus Gains U.S. Reimbursement for GI Procedure

Updated Category News Views 64

Olympus Secures Reimbursement for Vital GI Procedure When it comes to navigating the health sector, you learn to spot the plays that set the stage for long-term change. Olympus Corporation just announced something worth your attention if you're eyeing the med-tech world. The Centers for Medicare & Medicaid Services (CMS) have greenlit reimbursement rates for the...

Continue Reading
Hollyland Powers APEC 2026 with Wireless Solutions

Updated Category News Views 56

APEC 2026 Finds a Partner in Hollyland Here's a nugget for ya: Hollyland, the pride of Shenzhen in wireless audio and video solutions, is stepping into the big leagues by becoming an official sponsor for the APEC 2026 meetings. Now that's quite the homecoming parade! Given the bustling vibes of a global conference, Hollyland’s gear will play a starring role in keeping...

Continue Reading
SupplyHouse Expands to Atlanta: Faster Delivery Insights

Updated Category News Views 100

Revving Up in Atlanta: SupplyHouse's Bold Move Folks, this isn’t just another blip on the logistical radar. SupplyHouse, a key player in the plumbing, HVAC, and electrical supply scene, is laying down roots in Atlanta. Yeah, just outside the bustling heart of the Southeast, they’re throwing up a fulfillment center as big as a small city block—715,000 square feet to...

Continue Reading
Vijit Chao Phraya 2026: Transforming Bangkok with Light

Updated Category News Views 51

Bangkok's Night Sky Turns into an Artistic Canvas You think light shows are done and dusted? Think again. The Vijit Chao Phraya 2026 kicks off yet another spellbinding spectacle along the beloved river, turning Bangkok's waterline into an electrifying canvas of color and culture. For a month, from November 13 to December 13, this unique event unfolds across 19 different...

Continue Reading
Genesis One Rolls Out Telehealth Wellness Platform

Updated Category News Views 15

Genesis One Enters the Fray with Home-Based Wellness In a health industry where everyone's screaming for transparency and flexibility, Genesis One is finding a sweet spot. They're throwing their hat in the ring with a new telehealth wellness pitch. Now, this isn't your everyday launch—it's a prelude to a January 2027 rollout, with co-founders Brent Messer and Dr. Alex...

Continue Reading
Lucas Bols Wins Spirit Brand of the Year 2026

Updated Category News Views 111

Lucas Bols: A Legacy Crowned A 450-year-old legacy finally gets its due with the Lucas Bols Company snagging the "Spirit Brand of the Year" title from Wine Enthusiast. This ain’t just another pat on the back; it's a serious nod to a brand that’s been laying down the cocktail foundation long before some countries even existed. Across the past five centuries, they've...

Continue Reading
Chicken Salad Chick Expands in PA with Collegeville Launch

Updated Category News Views 56

Chicken Salad Chick Expands Further into Pennsylvania Hot off the grill! If you're in Pennsylvania, especially around Collegeville, you might want to perk up. Chicken Salad Chick, that quirky Southern-style restaurant chain that's all about—you guessed it—chicken salad, is doubling down on its presence in the state. Come November 18, chicken enthusiasts can graze on...

Continue Reading
Keurig Dr Pepper's Bold $2B Offering: Strategic Shift

Updated Category News Views 132

Strategic Moves Behind KDP's $2 Billion Offering Walking through all this, Keurig Dr Pepper (NASDAQ:KDP) has set the stage for something big. Yeah, I'm talking about a hefty $2 billion underwritten public offering. It's one of those moves where you're either shaking your head in confusion or nodding in cautious approval. With the coffee behemoth taking this step, let's...

Continue Reading
BlackRock's New Twist on Pension-Like 401(k) Benefits

Updated Category News Views 97

Rethinking Retirement: BlackRock's Pension-Style 401(k) Plans Everyone and their grandma knows the traditional pension is on life support in America's workforce. BlackRock's latest moves might just be that little jolt the market needs to reinject a bit of certainty for retirees. Nick Nefouse, steering the ship at BlackRock's Retirement Solutions, hopped on the Retirement...

Continue Reading

Top 5 Most Recently Viewed Articles

Market Insights: Evaluating Labor Data's Impact on Fed Decisions

Updated Category News Views 95

Understanding the Nonfarm Payroll Report The U.S. Bureau of Labor Statistics has released important findings in the latest nonfarm payroll report, showing an increase of 142,000 jobs over the past month. This number fell short of the anticipated 161,000 jobs, prompting a reevaluation of the labor market's strength. Additionally, the report noted a slight dip in the...

Continue Reading
Insights into Jyske Bank's Recent Share Repurchase Activity

Updated Category News Views 204

Understanding Jyske Bank's Share Repurchase Programme In the dynamic world of finance, share repurchase programmes play a vital role in a company's strategy, and Jyske Bank is no exception. This intriguing initiative commenced on an important date, aiming to enhance shareholder value while demonstrating confidence in the bank's fundamentals. With a commitment to buy back...

Continue Reading
Agile Consulting Group Partners with LeadingAge Washington to Enhance Financial Care

Updated Category News Views 181

Agile Consulting Group Teams Up with LeadingAge Washington Recently, Agile Consulting Group, a firm specializing in sales tax exemption and compliance, has formed a new partnership with LeadingAge Washington. This association aims to provide essential sales tax services to member organizations dedicated to improving the quality of life for older adults and their families....

Continue Reading
BENF Earnings Preview: Will They Bounce Back or Sink Deeper?

Updated Category News Views 263

Beneficient (NASDAQ:BENF) is gearing up to drop its latest quarterly earnings report on February 17, 2026, and traders are already sizing up their positions. Analysts are bracing for an earnings per share (EPS) of $-0.15. Sure, that’s a slight improvement over prior estimates, but given last quarter's staggering miss—where they fell short by $3.92—you’ve got to...

Continue Reading
Understanding Riksbank's Government Bonds Auction Process

Updated Category News Views 242

Overview of Riksbank Government Bonds Auctions The Riksbank plays a crucial role in managing Sweden's monetary policy, and a part of this function includes conducting government bonds auctions. This system enables the government to raise funds efficiently while providing investors a secure means of investing in Swedish debt. Understanding how these auctions operate can...

Continue Reading