medical device guru

Biologics, Wound Care, Infection Prevention

Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® to Coagulate and Contract Soft Tissues

Apyx Medical Corporation (NASDAQ:APYX), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the use of the Renuvion...

March 2, 2023

Biologics, Wound Care, Infection Prevention

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...

February 8, 2023

Biologics, Wound Care, Infection Prevention

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...

September 26, 2022

Biologics, Wound Care, Infection Prevention

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,...

May 11, 2022

Biologics, Wound Care, Infection Prevention

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,...

December 16, 2020

Biologics, Wound Care, Infection Prevention

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...

June 26, 2020

Biologics, Wound Care, Infection Prevention

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....

May 28, 2020

Biologics, Wound Care, Infection Prevention

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...

May 26, 2020

Biologics, Wound Care, Infection Prevention

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

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...

May 11, 2020