CoolHealth Enters U.S. Market With TargetCool™, A Breakthrough FDA-Class II Medical Device Offering Unprecedented Precise, Rapid Cooling For Pain Management And Bruise Minimization

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…

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Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia

Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. This…

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X-Therma Receives FDA Breakthrough Device Designation for XT-ViVo® Preservation Solution and TimeSeal® Organ Transport Device

X-Therma Inc., a biotechnology company developing breakthrough technology for regenerative medicine and organ preservation – announced today that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has granted its proprietary organ preservation solution, XT-ViVo®, and TimeSeal® Organ Transport Device, Breakthrough Device status. This designation is granted to products that have…

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Integra LifeSciences to Acquire ACell for $300M

Integra LifeSciences Holdings Corporation (NASDAQ:IART) a leading global medical technology company, today announced it has entered into a definitive agreement to acquire ACell, Inc. (“ACell”) for an upfront cash payment of $300 million at closing, subject to customary purchase price adjustments, and cash payments of up to an additional $100 million upon the achievement of certain…

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EO and UVDI Lead Trans-Pacific Fight to Flatten the COVID-19 Curve

EO Medical Pte. Ltd., announced in partnership with UltraViolet Devices, the global leader in UV-C disinfecting robots, that six additional UVDI-360 robots have been deployed in Singapore to curb the spread of coronavirus. UVDI-360 UV-C robots, manufactured in the greater Los Angeles area, are the most widely used disinfecting robot in Singapore’s top hospitals. “Protecting…

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AIROS Medical Launches New Compression Therapy Device and Garment System to Treat Breast Cancer Patients


AIROS® Medical, Inc., a medical technology manufacturer specializing in compression therapy products that treat cancer-related lymphedema and venous complications, today announced the launch of its updated AIROS 6 Sequential Compression Therapy device and Arm Plus garments following multiple regulatory approvals. AIROS received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its updated AIROS…

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STERIS Announces Second On-site Decontamination Solution for Respiratory Masks


STERIS plc announced that the U.S. Food and Drug Administration (FDA) has issued another Emergency Use Authorization (EUA) for respirator decontamination.  The EUA enables healthcare providers to decontaminate surgical N95 respirators by utilizing certain AMSCO Steam Sterilizers that have been upgraded with STERIS’s new “Decon” cycle. This EUA is the second authorization for STERIS to…

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Cleanbox Technology to Help Combat COVID-19 PPE Shortage by Allowing Safe Reuse of N95 Masks

Cleanbox UVC device

Smart tech hygiene company Cleanbox Technology, Inc. has announced a new product, the CleanDefense™, a point-of-use mask decontamination product in response to SARS CoV-2 (COVID-19). Cleanbox’s patented technology uses UVC light in an LED to decontaminate hard-to-clean products worn on the face or head. With a focus on high risk contagion transfer points, its core products were designed…

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HealthySole HOME Approved to Keep Your Home Safe From COVID-19


Researchers have proven a device using ultraviolet light technology can neutralize the COVID-19 virus and other infectious diseases on the soles of shoes by more than 99.5 percent, according to a new study. The device, called HealthySole® PLUS, is being introduced in hospitals and other settings where infection control is urgent. A home version of the…

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Sterilucent Granted Emergency Use Authorization to Reprocess Respirators


The U.S. Food and Drug Administration has granted Sterilucent, Inc. (Minneapolis, MN), an Emergency Use Authorization to allow the emergency use of the Sterilucent™ HC 80TT Vaporized Hydrogen Peroxide Sterilizer for decontaminating single-use compatible N95 and N95-equivalent respirators. Test results have demonstrated that filtering facepiece respirators may be reprocessed for use during the COVID-19 pandemic…

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