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Diagnostics & Healthcare News

Invictus Announces FDA Clearance of Ground-Breaking Neoasis® ANC Device

Invictus Medical announced today that the culmination of their De Novo application to the FDA for its Neoasis® incubator-based active noise control (ANC) device has resulted in a clearance-for-use declaration by the FDA. “With this clearance for use, Invictus has made a huge...

July 11, 2023

Diagnostics & Healthcare News

KORU Medical Systems, Inc. Announces 510(K) Submission for Freedom60® Infusion System With Hizentra® 50 Ml Prefilled Syringes

KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty subcutaneous infusion solutions that improve quality of life for patients, today announced...

July 10, 2023

Biologics, Wound Care, Infection Prevention

Coloplast Announces Agreement to Acquire Kerecis and Raises Long-term Growth Expectations

Coloplast has signed an agreement to acquire Kerecis, an innovative, fast-growing company in the biologics wound care segment, for up to USD 1.3 billion (around DKK 8.9 billion), of which USD 1.2 billion (around DKK 8.2 billion) is an upfront...

July 7, 2023

Biologics, Wound Care, Infection Prevention

MedRhythms Announces FDA Listing of InTandem™ (MR-001) to Improve Walking and Ambulation in Adults with Chronic Stroke

MedRhythms announced that MR-001, the company’s evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device with the U.S. Food and Drug Administration (FDA). The system...

July 6, 2023

Biologics, Wound Care, Infection Prevention

Cresilon Receives First FDA Clearance For Human Use of Hemostatic Gel Technology

Cresilon, Inc. (“Cresilon”), a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel™ (“CHG™”). This marks Cresilon’s first FDA clearance...

June 30, 2023

Surgery and Surgical Robotics

USMI Receives FDA Approval for New Robotic Surgery Device – The Canady Flex RoboWrist™

US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC, announced today it has received FDA Approval for its Canady Flex RoboWrist™ to be used in open and laparoscopic procedures in the United States....

June 29, 2023

Biologics, Wound Care, Infection Prevention

Candela Medical Receives FDA Clearance for Vbeam 595 nm Pulsed Dye Laser, a Treatment for Port Wine Stains and Hemangiomas in Pediatric Cases

Candela Corporation (Candela), a leading global medical aesthetic device company headquartered in Marlborough, MA, today announced that the Vbeam Family of Pulsed Dye Lasers (PDL) has expanded its FDA cleared indications for use of the 595 nm wavelength to include the pediatric...

June 28, 2023

Orthopedics and Spine

PathKeeper Surgical Commercializes Spine Navigation System with First U.S. Cases

PathKeeper Surgical, a privately-held, Israel-based, medical technology company, dedicated to improving the health of individuals around the world suffering from all spinal issues requiring surgery, while making navigation-guided surgery available to any patient in all operating rooms, announces the first commercial use...

June 27, 2023

Orthopedics and Spine

Conformis Announces Definitive Agreement to be Acquired by restor3d for a Purchase Price of $2.27 Per Share in Cash

restor3d, Inc. and Conformis, Inc. (NASDAQ: CFMS) announced today that they have entered into a definitive merger agreement under which restor3d, a leading personalized 3D-printed orthopedic company, will acquire all outstanding shares of common stock of Conformis at $2.27 per...

June 26, 2023