medical device guru

Biologics, Wound Care, Infection Prevention
Critical Innovations Receives Breakthrough Device Designation for FOAM Device
Critical Innovations announced earlier this week that the FDA has granted breakthrough device designation for its “Fast Onset Abdominal Management™ (F.O.A.M.™) device, which is designed to deliver a quickly-expanding foam to tamponade severe internal bleeding in trauma patients. F.O.A.M.™ research...
July 3, 2019
Biologics, Wound Care, Infection Prevention
Smith & Nephew to Buy Osiris Therapeutics for $660 Million
Smith & Nephew said today that it agreed to put $660 million on the table to acquire Osiris Therapeutics and its regenerative medicine portfolio. The British orthopedics and wound care giant said the $19-per-share deal is a 37% premium on the 90-day volume-weighted...
March 12, 2019
Biologics, Wound Care, Infection Prevention
Fish-Skin Wound Care Company Gets Swiss Approval, Makes Acquisition
Kerecis, the company pioneering the use of fish skin in tissue regeneration, today received a notice from Swiss healthcare authorities that the company’s lead product, Kerecis Omega3 Wound, will be reimbursed in Switzerland. The company will also acquire the Swiss life-science...
February 11, 2019
Biologics, Wound Care, Infection Prevention
FDA Grants De Novo Authorization to Pressure Ulcer Risk Assessment Device
Bruin Biometrics, LLC has been granted U.S. Food and Drug Administration marketing authorization for the SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the standard of care when assessing patients who are at...
January 7, 2019
Biologics, Wound Care, Infection Prevention
AVITA Medical’s “Spray-On Skin” Approved to Treat Serious Burns
AVITA Medical, a Valencia, California firm, won FDA approval for its remarkable RECELL Autologous Cell Harvesting Device for serious burns in adult patients. In preparation for treatment, a small healthy piece of the patient’s skin sample is taken, from which...
September 25, 2018
Biologics, Wound Care, Infection Prevention
Avista to acquire Organogenesis
Avista Healthcare Public Acquisition Corp., a publicly traded special purpose acquisition company, and Organogenesis Inc., a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care, Surgical and Sports Medicine markets,...
August 20, 2018
Biologics, Wound Care, Infection Prevention
MolecuLight’s First-of-its-kind Handheld Wound Imaging Device Receives FDA De Novo Clearance
MolecuLight Inc. achieved a major regulatory milestone permitting expansion into the United States market. FDA has granted De Novo clearance for the ground-breaking wound fluorescence imaging device, the MolecuLight i:X. The device digitally captures and documents fluorescence information from wounds and surrounding tissue...
August 16, 2018
Biologics, Wound Care, Infection Prevention
Innovative Bedside Biologic Maker RedDress Receives 510(k) for RD1 System
RedDress Ltd announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RD1 system. RD1 is an innovative wound care product which enables health care providers to produce in real time, in vitro whole...
July 16, 2018
Biologics, Wound Care, Infection Prevention
Implantable Organ Developer Miromatrix Raises Additional $15.7M in Series B Funding
July 12, 2018 – Press Release by Miromatrix Medical Miromatrix Medical Inc. is excited to announce it recently raised $15.7 million in Series B-2 funding, surpassing its goal of $10 million. As part of the round, Miromatrix also welcomed its...
July 12, 2018
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