HemoSonics Quantra QStat Cartridge
Device Digest

FDA Grants HemoSonics Expanded Use of its Critical Bleeding Management System with Special 510(k) Clearance

HemoSonics, a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of arterial blood samples with its Quantra QStat® Cartridge. HemoSonics’ QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the U.S. […]

NEOS Surgery Cranial LOOP™ Fixation System
Device Digest

NEOS Cranial LOOP™ Receives FDA Clearance for CustomizedBone™ Use

Kelyniam Global (OTC:KLYG) and Fin-ceramica, Faenza S.p.a., makers of custom cranial implants, announced today that the NEOS Surgery Cranial LOOP™ fixation system has received 510(k) clearance from the FDA for use with Finceramica’s CustomizedBone™ hydroxyapatite cranial implant. The Cranial LOOP™ family of cranial fixation devices is a smart system made of PEEK-OPTIMA™, a biocompatible polymer, for […]

ExactechGPS Guided Knee Surgery
Device Digest

New Knee Research Finds Exactech Technologies Improve Patient Outcomes

Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced new research that reports surgeons using ExactechGPS® guided personalized surgery and its Newton® ligament-driven balancing technique experience clinically significant improvements on postoperative Knee Society Knee and Function scores when compared to traditional navigated gap balancing methods, according to a […]

Mediwave's innovative emergency response suite showcased at Global Mobile Awards
Device Digest

Mediwave Wins Global Recognition at GLOMO Awards 2024 for Health Technologies for Emergency Response

Mediwave, a leading health technology company, has been recognized as a finalist in the prestigious Global Mobile Awards (GLOMO), part of the Mobile World Congress (MWC) hosted by the GSMA in Barcelona, Spain. This recognition highlights Mediwave’s outstanding contributions in this field, particularly its innovative and integrated use of AI, the Internet of Medical Things […]

"Nexalin Gen-2 Neurostimulation Device"
Device Digest

Nexalin Technology Commences Sales of Gen-2 Neurostimulation Device to New Mental Health Center in Oman Dedicated to Nexalin’s Technology

Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today announced that it has commenced sales of its second generation (Gen-2), 15 milliamp (mA) neurostimulation device into a new mental health center in Oman, dedicated to the use of Nexalin’s neurostimulation device for the treatment of patients with substance abuse disorder (SUD). The new […]

"Ocugen OCU410 Clinical Trial"
Device Digest

Ocugen, Inc. Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 1 of Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410

Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced […]

"Beckman Coulter Fujirebio Neurodegenerative Assays"
Device Digest

Beckman Coulter and Fujirebio Expand Partnership to Develop Patient-friendly, Blood-based Neurodegenerative Disease Diagnostics

Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced an expansion of their partnership focused on development, manufacturing and clinical adoption of neurodegenerative disease assays. In 2023, Beckman Coulter and Fujirebio entered into a collaboration agreement focused on new biomarkers aligned with […]

Surgeon reviewing 3D printed model of a foot joint implant.
Device Digest

OrthoVentions Invests in Motio[OV] to Develop 3D Printed Implant and Instruments to Treat Joint Arthritis of the Big Toe

OrthoVentions LLC today announced its investment in MotioOV, an early-stage company created in partnership with the Hospital for Special Surgery (HSS). MotioOV is developing a novel 3D printed implant and custom instruments to address stiffness and pain associated with arthritis of the first metatarsophalangeal (MTP) joint. Under the terms of the investment, the company will be […]

Duchenne Muscular Dystrophy Clinical Trial
Device Digest

PepGen Announces Clearance of CTA by UK Medicines & Healthcare Products Regulatory Agency to Begin CONNECT2-EDO51, a Phase 2 Clinical Trial designed to support potential accelerated approval of PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has authorized its Clinical Trial Application (CTA) to initiate the CONNECT2-EDO51 Phase 2 clinical trial […]

"Illustration depicting ankle replacement surgery"
Device Digest

Father of Exactech Employee Receives First Ankle Replacement Using Activit-E™ Polyethylene

Exactech Quality Control Manager Wesley Garrett experienced a full circle moment in both his professional and personal life when his father received an Activit-E™ polyethylene insert after following the company’s polyethylene initiatives for six years.  In 2018, Garrett was hired as an intern to perform wear-testing for the company’s hip product line. Specifically, he tested results between vitamin E-infused […]