News

Breakthrough Medical Device Start-up Attune Medical Names Industry Veteran Keith Warner as COO

June 20, 2017

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] [Medical Device News] [Fierce Biotech]


Breakthrough Start-up Advanced Cooling Therapy Announces Name Change to Attune Medical

June 6, 2017

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


Breakthrough Start-up Advanced Cooling Therapy Receives 510(k) Clearance from FDA for Use with New Control Unit

April 13, 2017

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]


Advanced Cooling Therapy Receives Innovative Technology Contract from Vizient, Inc. for Novel Patient Temperature Management Product

February 17, 2017

“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]


ACT Awarded GPO Agreement for Breakthrough Technology in Patient Temperature Management Products with Premier, Inc.

January 10, 2017

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]


Advanced Cooling Therapy’s ECD featured in “Start-Up” by Pharma Intelligence Informa

 

May 26, 2016

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]


European Union Expands CE Mark Approval to Advanced Cooling Therapy’s Esophageal Cooling Device for 120 Hours Duration of Use

May 25, 2016

Advanced Cooling Therapy has received CE Mark approval for an expanded indication for use of its Esophageal Cooling Device (ECD). [BusinessWire]


Advanced Cooling Therapy featured as a “Start Up to Watch” in the The MedTech Strategist

 

April 29, 2016

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]


New Data Show Success with Advanced Cooling Therapy’s Esophageal Cooling Device to Manage Care of Burn Patients

March 2, 2016

An article published in Case Reports in Anesthesiology (http://www.hindawi.com/journals/cria/2016/7306341/) 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]


Medical Device Firm Advanced Cooling Therapy Receives 510(k) Clearance from FDA for Second Esophageal Cooling Device to Cool and Warm Patients

January 19, 2016

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]


Medical Device Firm Advanced Cooling Therapy Expands Team, Hits Growth Milestones with Commercial Launch of Esophageal Cooling Device

November 18, 2015

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]


Advanced Cooling Therapy Snags FDA De Novo Clearance for Esophageal Cooling Device

June 25, 2015

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]


5 Game-Changing Medical Devices from the Last 10 Days

June 24, 2015

[…]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]

Advanced Cooling Therapy Wins FDA Nod

June 24, 2015

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]


Esophageal Cooling Device First to Control Body Temp from Within

June 24, 2015

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]


Medical Device Firm Advanced Cooling Therapy Receives FDA De Novo Clearance for Esophageal Cooling Device to Cool and Warm Patients

June 24, 2015

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]


The Esophageal Cooling Device Gets FDA’s Rare De Novo Clearance for Innovative Devices

June 24, 2015

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]


Advanced Cooling Therapy Receives FDA Clearance for Esophageal Cooling Device to Cool and Warm Patients

June 24, 2015

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]


Advanced Cooling Therapy’s Esophageal Cooling Device Shows Benefits in Heat Conduction to Warm Patients

June 10, 2015

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]