News

October 12, 2023

MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device

Attune Medical’s ensoETM is a single use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for proactive controlled temperature management.

SEPTEMBER 26, 2023

Study Finds Significant Reduction in Esophageal Injury Rate When Using ensoETM™ During Cardiac Radiofrequency Ablation Procedures

The study, Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation, set out to compare the rate of AEFs before and after the adoption of proactive esophageal cooling. [Business Wire]

SEPTEMBER 14, 2023

Attune Medical’s ensoETM™ Granted FDA De Novo Marketing Authorization to Reduce the Likelihood of Ablation-related Esophageal Injury Resulting from Radiofrequency Cardiac Ablation Procedures

The FDA based its decision on pre-clinical studies, computer models, three randomized controlled studies, and data on tens of thousands of patients treated in real-world uses. [Business Wire]

AUGUST 30, 2023

Attune Medical Announces Non-Exclusive Distribution Agreement with Gentherm to Provide Blanketrol® III Heat Exchangers to ensoETM Users

Adopters of Attune’s ensoETM thermal regulating device will be provided the opportunity to use a bundled disposable purchase option to acquire Gentherm’s Blanketrol III directly from Attune.

MAY 09, 2023

Attune Medical to Attend Heart Rhythm Society May 19 to 21 in New Orleans

The company will show the latest proactive esophageal cooling technology at Booth 521 and host an evening meet-and-greet. [Business Wire]

APRIL 11, 2023

Attune Medical and Heart Rhythm Clinical Research Solutions (HRCRS) Collaborate With Real World Evidence Consortium Members to Evaluate ensoETM™ in High Volume Centers

The RWE consortium consists of approximately 50 US high-volume electrophysiology centers that perform procedures such as cardiac radiofrequency ablation for the treatment of atrial fibrillation. [HMP Global]

September 08, 2022

FDA Grants IDE Approval to Evaluate Attune Medical’s ensoETM in Radiofrequency Ablation Procedures

The US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to Attune Medical to evaluate the company’s ensoETM in the reduction of esophageal thermal injury during cardiac radiofrequency ablation procedures. [Business Wire]

MAY 24, 2022

First Patients Enrolled in IMPACT II Study to Evaluate Attune Medical’s ensoETM for Radiofrequency Ablation Procedures Attune Medical, a pioneering medical device company with a technology platform based on temperature management using the esophagus, announced today that the first patients have been enrolled in the Improving Oesophageal Protection During Catheter Ablation for Atrial Fibrillation (IMPACT II) Study evaluating the use of the ensoETM in cardiac radiofrequency ablation procedures. [Business Wire]

OCTOBER 28, 2021

Industry Veteran Ty Miller Joins Attune Medical as National Sales Director Attune Medical, a pioneering medical device company with a technology platform based on temperature management using the esophageal space, has added Ty Miller to the management team as National Sales Director. [Business Wire]

DECEMBER 3, 2020

Significant Milestones in Clinical Development and Continued Fundraising Support Attune Medical’s Aggressive Growth Strategy Attune Medical, a breakthrough medical device company with a technology platform based on targeted temperature management using the esophageal space, has achieved significant corporate milestones as part of the company’s aggressive growth plan. [Business Wire]

OCTOBER 27, 2020

Could a fever help the sickest COVID-19 patients? The thought of developing a fever — one of the most common symptoms of COVID-19 — is terrifying for many of us these days. For Dr. David Willms, fevers could be a way to save more lives. [SHARP]

APRIL 28, 2020

Chicago Is Uniting For The Greater Good. Housed in the University’s Tech Park, Attune Medical is a medical device company that is now aiming to help patients who suffer from respiratory failure caused by COVID-19. The company is currently working with world experts to evaluate efficacy in treating infections. [Forbes]

NOVEMBER 21, 2019

Ongoing Clinical Studies Investigate Esophageal Injury Prevention During Cardiac Ablation Procedures Using Attune Medical’s ensoETM Chicago-based medical device firm Attune Medical’s ensoETM is being evaluated in numerous ongoing clinical studies to investigate device efficacy in reducing thermal injury to the esophagus during cardiac ablation procedures, a common treatment for atrial fibrillation. [Business Wire]

SEPTEMBER 24, 2019

Attune Medical Expands IP Portfolio with Issuance of Additional Patent from USPTO and Acquisition of License from Stanford University. Chicago-based medical device firm Attune Medical has expanded its pioneering patent portfolio with two major advancement

SEPTEMBER 5, 2018

Atune’s Oversubscribed Round Shows It Resonates with Investors The Chicago-based company said it has raised $15M in a series C round and the financing would go toward supporting the adoption of its Esophageal Temperature Management technology. [MD+DI]

JANUARY 9, 2018

Attune Medical’s ensoETM featured in Anesthesiology News The new ensoETM was featured on the Anesthesiology News website. Anesthesiology News, now in its 43rd year, has been the best-read publication for the specialty for the last 20 years. [Anesthesiology News]

JANUARY 8, 2018

Breakthrough Start-up Attune Medical Receives 510(k) Clearance from FDA: New Device for Feeding and Medication Administration Using Standardized Connector and EnsoETM Attune Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for a new ensoETM model capable of administering tube feeds and/or medication while simultaneously cooling or warming patients using the esophageal space. [Businesswire]

DECEMBER 19, 2017

Clinical Study Shows Cost Savings and Fewer Interventions with Esophageal Cooling Therapy Using Attune Medical’s ensoETM A new clinical study has demonstrated that Attune Medical’s ensoETM esophageal temperature management device reduced shivering and medication costs when compared to other methods of temperature management to achieve normothermia in patients with non-traumatic brain injury. The study, published in the journal Therapeutic Hypothermia and Temperature Management, compared the EnsoETM to both surface and endovascular temperature modulating devices in a total sample of 32 patients (8 EnsoETM recipients and 24 controls). [Businesswire]

OCTOBER 25, 2017

Patient Temperature Management Start-up Attune Medical’s EnsoETM Cleared by FDA for Extended Duration of Use Chicago-based medical device firm Attune Medical has received notification from the US Food and Drug Administration (FDA) that it has cleared the ensoETM esophageal temperature management device for an extended duration of use for up to 72 hours. [Businesswire]

OCTOBER 5, 2017

Clinical Study Published in Resuscitation Demonstrates Efficacy and Safety of Attune Medical’s EnsoETM for Cooling and Rewarming Patients A clinical study published in the journal Resuscitation has demonstrated the efficacy and safety of Attune Medical’s EnsoETM in cooling and rewarming patients after out-of-hospital cardiac arrest (OHCA). The article, “Targeted Temperature Management Using The Esophageal Cooling Device After Cardiac Arrest (The COOL Study)”, assessed the performance and safety of the EnsoETM (previously named the Esophageal Cooling Device, or ECD) during a Targeted Temperature Management (TTM) protocol. [Businesswire]

JUNE 20, 2017

Breakthrough Medical Device Start-up Attune Medical Names Industry Veteran Keith Warner as COO Attune Medical (formerly Advanced Cooling Therapy), an emerging medical device firm, has hired industry veteran Keith Warner as Chief Operating Officer. Mr. Warner is a seasoned executive in the life science and diagnostic industry with over three decades of experience building high value companies. [BusinessWire] [Fierce Biotech]

JUNE 6, 2017

Breakthrough Start-up Advanced Cooling Therapy Announces Name Change to Attune Medical Advanced Cooling Therapy (ACT), an emerging medical device manufacturer, has announced that it is changing its corporate name to Attune Medical. [BusinessWire]

APRIL 13, 2017

Breakthrough Start-up Advanced Cooling Therapy Receives 510(k) Clearance from FDA for Use with New Control Unit Advanced Cooling Therapy (ACT) has received 510(k) clearance from the US Food and Drug Administration (FDA) for use of its Esophageal Cooling Device (ECD) with the Altrix Precision Temperature Management System by Stryker®. [Businesswire]

FEBRUARY 17, 2017

Advanced Cooling Therapy Receives Innovative Technology Contract from Vizient, Inc. for Novel Patient Temperature Management Product “Due to the number of products and services being released and marketed as ‘innovative’, member hospitals value the thorough innovative technology review process in place at Vizient to help them identify products worth further evaluation at their own facilities,” said Debbie Archer, director of procurement and leader of Vizient’s Innovative Technology program for suppliers. “After a full review of the Esophageal Cooling Device, Vizient’s member council agreed this solution offers unique and incremental benefit over other products available on the market today, and recommended it for an Innovative Technology contract. We are pleased to award this new contract to Advanced Cooling Therapy.” [BusinessWire]

JANUARY 10, 2017

ACT Awarded GPO Agreement for Breakthrough Technology in Patient Temperature Management Products with Premier, Inc. Effective January 1, 2017, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for ACT’s novel Esophageal Cooling Device (ECD). [BusinessWire]

MAY 26, 2016

Advanced Cooling Therapy’s ECD featured in “Start-Up” by Pharma Intelligence Informa Start-Up provides in-depth profiles of leading-edge companies and technologies, including the most important new trends in the biopharma, medtech and diagnostics industries. [Start-Up]

MAY 25, 2016

European Union Expands CE Mark Approval to Advanced Cooling Therapy’s Esophageal Cooling Device for 120 Hours Duration of Use Advanced Cooling Therapy has received CE Mark approval for an expanded indication for use of its Esophageal Cooling Device (ECD). [BusinessWire]

APRIL 29, 2016

Advanced Cooling Therapy featured as a “Start Up to Watch” in the The MedTech Strategist The MedTech Strategist, the medical device news and analysis publication from Innovation in MedTech, covers Advanced Cooling Therapy’s next-generation of therapeutic hypothermia and warming technologies. [Innovation in Medtech]

MARCH 2, 2016

New Data Show Success with Advanced Cooling Therapy’s Esophageal Cooling Device to Manage Care of Burn Patients An article published in Case Reports in Anesthesiology has demonstrated the successful use of Advanced Cooling Therapy (ACT)’s Esophageal Cooling Device (ECD) in managing the temperature of patients with extreme burn injuries. [BusinessWire]

JANUARY 19, 2016

Medical Device Firm Advanced Cooling Therapy Receives 510(k) Clearance from FDA for Second Esophageal Cooling Device to Cool and Warm Patients Emerging medical device firm Advanced Cooling Therapy (ACT) has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its second product, the Esophageal Cooling Device (ECD-02), in the United States. [BusinessWire]

NOVEMBER 18, 2015

Medical Device Firm Advanced Cooling Therapy Expands Team, Hits Growth Milestones with Commercial Launch of Esophageal Cooling Device Medical device firm Advanced Cooling Therapy (ACT) has expanded its team and achieved several strategic milestones in the commercial launch of its first product, the Esophageal Cooling Device (ECD). [BusinessWire]

JUNE 25, 2015

Advanced Cooling Therapy Snags FDA De Novo Clearance for Esophageal Cooling Device Advanced Cooling Therapy’s first product, the Esophageal Cooling Device, has secured FDA de novo clearance. The Chicago, Ill.-based devicemaker says the product is the only temperature modulation device on the market that uses the esophageal space to cool or warm patients. [FDANews]

JUNE 24, 2015

5 Game-Changing Medical Devices from the Last 10 Days The ECD is used to cool patient body temperature via the oesophagus. It is a disposable, single use device that has three channels, two of which are for running fluids and the third one for drainage and decompression. It has just been FDA-approved. [Medical Plastics News]

JUNE 24, 2015

Advanced Cooling Therapy Wins FDA Nod Advanced Cooling Therapy said it won de novo clearance from the FDA for its esophageal cooling device, claiming it as the sole temperature modulation device to use the esophagus. The ECD, which won CE Mark approval in the European Union last year and is on the market in Canada and Australia, is slated to hit the U.S. market within 30 to 45 days, Advanced Cooling Therapy said. [Mass Device]

JUNE 24, 2015

June 24, 2015

Esophageal Cooling Device First to Control Body Temp from Within Advanced Cooling Therapy, a company based in Chicago, IL, received de novo FDA clearance for its Esophageal Cooling Device (ECD), in effect creating a new category of regulated medical devices.The ECD is used to cool patient body temperature via the esophagus. It is a disposable, single use device that has three channels, two of which are for running fluids and the third one for drainage and decompression. [medGadget]

JUNE 24, 2015

Medical Device Firm Advanced Cooling Therapy Receives FDA De Novo Clearance for Esophageal Cooling Device to Cool and Warm Patients Emerging medical device firm Advanced Cooling Therapy has received a de novo clearance from the US Food and Drug Administration (FDA) to market its first product, the Esophageal Cooling Device (ECD), in the United States. The ECD is the only temperature modulation device available today that uses the esophageal space to cool or warm patients. It received its CE Mark in Europe in 2014, is licensed for sale in Canada and Australia, and will be available to medical professionals in the US within 30 to 45 days. [BusinessWire]

JUNE 24, 2015

The Esophageal Cooling Device Gets FDA’s Rare De Novo Clearance for Innovative Devices Advanced Cooling Therapy’s Esophageal Cooling Device has just received the FDA’s de novo clearance. That’s a strong sign that it’s an innovative technology, for the de novo clearance is reserved for low- to moderate-risk devices that don’t have a “substantially equivalent” predecessor on the market. The device controls patients’ whole-body temperature using temperature modulation equipment that’s inserted into the esophagus. [FierceMedicalDevices]

JUNE 24, 2015

Advanced Cooling Therapy Receives FDA Clearance for Esophageal Cooling Device to Cool and Warm Patients Emerging medical device firm Advanced Cooling Therapy has received a de novo clearance from the US Food and Drug Administration (FDA) to market its first product, the Esophageal Cooling Device (ECD), in the United States. The ECD is the only temperature modulation device available today that uses the esophageal space to cool or warm patients. It received its CE Mark in Europe in 2014, is licensed for sale in Canada and Australia, and will be available to medical professionals in the US within 30 to 45 days. [Biological Quarterly]

JUNE 10, 2015

Advanced Cooling Therapy’s Esophageal Cooling Device Shows Benefits in Heat Conduction to Warm Patients Advanced Cooling Therapy’s first product, the Esophageal Cooling Device (ECD), is showing benefits in the conduction of heat for warming of patients in a controlled manner in new clinical settings. A site in the European Union has used the ECD to keep challenging patients, such as burn patients, warm while undergoing complex skin procedures in the operating room, which allows clinicians to accomplish more in one setting than they ordinarily could without the ECD. Clinical studies reporting these results are in progress. [BusinessWire]