Healthcare Industry News: FDA
News Release - February 8, 2023
CoolHealth Enters U.S. Market With TargetCool(TM), A Breakthrough FDA-Class II Medical Device Offering Unprecedented Precise, Rapid Cooling For Pain Management And Bruise Minimization
Groundbreaking Technology Brings New Standard of Cooling to Healthcare IndustryAUSTIN, Texas, Feb. 8, 2023 -- (Healthcare Sales & Marketing Network) -- Recens, Inc. dba CoolHealth ("CoolHealth"), a venture-backed medical device company developing innovative cooling technologies, is entering the U.S. market with a breakthrough FDA-Class II medical device, TargetCool™. Leveraging groundbreaking, tuneable cooling technology, TargetCool rapidly cools the skin allowing providers to specifically set a "target" skin temperature down to the exact degree and second– a first in medical cooling. This allows providers to combine TargetCool™ with other needle-based procedures to minimize patient pain, bruising, inflammation and hematoma that may occur post-procedure. Through this, TargetCool is creating a new standard of care in cooling and opening the door to an array of new treatment possibilities.
TargetCool has been proven to provide temporary analgesia to the skin for needle-based procedures in aesthetics such as Dermal Fillers, Toxin, and PRP injections, thus elevating patient comfort and reducing pain-related anxiety. TargetCool can also reduce bruising, inflammation, and swelling post-procedure. Moreover, TargetCool's rapidity obviates the need for time-consuming traditional methods for numbing treatment areas, such as topical creams, thus reducing patient wait-times and streamlining practice workflows. Reviews from early-adopters and their patients have been immensely positive.
"The TargetCool™ device is an easy-to-use system that has quickly become my go-to for pain management for various cosmetic procedures," said Gary Goldenberg, M.D., a board-certified dermatologist in New York City. "Having the option to minimize post-procedure bruising while increasing patient comfort has elevated the standard of care that I am able to provide patients."
TargetCool was created by award-winning South Korean mechanical engineer, Dr. Gun-Ho Kim, who specializes in thermal engineering. "We truly believe that TargetCool will change the face of cooling," Dr. Kim stated. "This is the first time we have had precise control over cooling temperature and duration. TargetCool is optimizing treatments for a variety of conditions, and creating unique, new treatment possibilities."
TargetCool offers providers a new standard of care with regard to patient comfort and procedure efficiency. For more information on the TargetCool Device please visit https://coolhealth.com/providers/home/
INDICATION
TargetCool™ is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
IMPORTANT SAFETY INFORMATION
Do not use the device for patients with cold urticaria, cryopathies such as cryoglobulinemia or cryofibrinogenemia, or paroxysmal cold hemoglobinuria.
®/TM are trademarks of CoolHealth
Any other product/brand names and/or logos are trademarks of the respective owners.
Source: CoolHealth
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