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Implants Nusurface Meniscus Implant Provides Articles & Analysis

20 news found

CELLINK and Ossiform Enter a Strategic Partnership to launch Ossi Ink, a printable bioink based on Ossiform’s P3D Bone material

CELLINK and Ossiform Enter a Strategic Partnership to launch Ossi Ink, a printable bioink based on Ossiform’s P3D Bone material

CELLINK and Ossiform have entered a strategic partnership to join forces to commercialize a ready-to-print bioink based on Ossiform’s existing biomaterial. Sales of the material will begin in 2024 and will be distributed co-exclusively through CELLINK’s commercial channels. Bone regeneration is one of the fastest growing research disciplines, given the massive impact it can have on ...

ByCELLINK


Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant

Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant

Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced that the NUsurface® Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration. The NUsurface® Meniscus ...

ByActive Implants LLC


3DBio Therapeutics and the Microtia-Congenital Ear Deformity Institute Conduct Human Ear Reconstruction Using 3D-Bioprinted Living Tissue Implant in a First-in-Human Clinical Trial

3DBio Therapeutics and the Microtia-Congenital Ear Deformity Institute Conduct Human Ear Reconstruction Using 3D-Bioprinted Living Tissue Implant in a First-in-Human Clinical Trial

3DBio Therapeutics (3DBio), a clinical-stage regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute announced they have conducted a human ear reconstruction using the AuriNovo™ implant, an investigational, patient-matched, 3D-bioprinted living tissue ear implant. The groundbreaking reconstructive procedure in the first-in-human Phase 1/2a clinical trial is ...

By3DBio Therapeutics


Exsomed Corporation Announces FDA 510(K) Clearance of the Nanophix Cannulated Lag Screw System for Fracture Fragments

Exsomed Corporation Announces FDA 510(K) Clearance of the Nanophix Cannulated Lag Screw System for Fracture Fragments

ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, received 510(k) clearance from the United States Food and Drug Administration (FDA) to commercialize its NanoPhix Cannulated Lag Screw system. The cannulated lag screw provides surgeons with a sterile, surgically efficient solution to optimize outcomes ...

ByExsoMed Corporation


Real-World Evidence Study Demonstrates Intersect ENT’s PROPEL Sinus Implant Reduces Healthcare Resource Utilization

Real-World Evidence Study Demonstrates Intersect ENT’s PROPEL Sinus Implant Reduces Healthcare Resource Utilization

Real-World Evidence Study Demonstrates Intersect ENT’s PROPEL® Sinus Implant Reduces Healthcare Resource Utilization Data from first-of-its-kind study published in Current Medical Research and Opinion Patients receiving PROPEL® following endoscopic sinus surgery had statistically significant lower healthcare resource utilization over a postoperative period of 18 months, ...

ByIntersect ENT, Inc.


Glaukos’ iDose TR Demonstrates Sustained IOP Reduction and Favorable Safety Profile Over 36 Months in Phase 2b Study

Glaukos’ iDose TR Demonstrates Sustained IOP Reduction and Favorable Safety Profile Over 36 Months in Phase 2b Study

Approximately 70% of Subjects were Well-Controlled on iDose TR with the Same or Fewer Topical IOP-Lowering Medications at 36 Months vs. Screening Favorable Safety Profile Through 36 Months . SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal ...

ByGlaukos Corporation


Contraline Secures $10.7M Series A

Contraline Secures $10.7M Series A

Contraline, Inc., a venture-backed medical device company devoted to providing men and couples with long-lasting, safe, and effective male contraception, has closed $10.7 million in its Series A financing. The financing round was led by MBX Capital, a venture capital firm that invests in early-stage healthcare and life sciences companies. Additional investors in Contraline include: Rhia ...

ByContraline, Inc.


Medtronic to Acquire Intersect ENT

Medtronic to Acquire Intersect ENT

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that it has entered into a definitive agreement with Intersect ENT (NASDAQ: XENT), a global ear, nose, and throat (ENT) medical technology leader dedicated to transforming patient care, in which Medtronic will acquire all outstanding shares of Intersect ENT for $28.25 per share in an all-cash transaction implying ...

ByIntersect ENT, Inc.


U.S. Nationwide Commercial Availability of the VenSure Balloon Sinus Dilation System and Cube Navigation System Highlight Intersect ENT’s Continued Commitment to Providing Innovative, Solutions for Patients with Chronic Rhinosinusitis

U.S. Nationwide Commercial Availability of the VenSure Balloon Sinus Dilation System and Cube Navigation System Highlight Intersect ENT’s Continued Commitment to Providing Innovative, Solutions for Patients with Chronic Rhinosinusitis

Intersect ENT®, Inc. (Nasdaq: XENT), a global ear, nose and throat (“ENT”) medical technology leader dedicated to transforming patient care, today announced the U.S. nationwide commercial availability of the VenSure™ Balloon Sinus Dilation System and Cube™4D Navigation System with VirtuEye™ photo registration. The VenSure Balloon and Cube 4D Navigation Systems ...

ByIntersect ENT, Inc.


Active Implants’ NUsurface Meniscus Implant Provides Statistically Superior Pain Relief

Active Implants’ NUsurface Meniscus Implant Provides Statistically Superior Pain Relief

Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced two-year results of the MERCURY study, which showed that the company’s NUsurface® Meniscus Implant provides statistically superior pain relief beginning at six months compared to ...

ByActive Implants LLC


Expand Post-Market Study Evaluating Longer-Term Outcomes of PROPEL Contour Sinus Implant in the Frontal Sinus Ostia Following In-Office Balloon Sinus Dilation

Expand Post-Market Study Evaluating Longer-Term Outcomes of PROPEL Contour Sinus Implant in the Frontal Sinus Ostia Following In-Office Balloon Sinus Dilation

Intersect ENT®, Inc. (Nasdaq: XENT), a global ear, nose and throat (“ENT”) medical technology leader dedicated to transforming patient care, today announced that it began the process of initiating the Company’s EXPAND Clinical Study by successfully registering on ClinicalTrials.gov (NCT04858802). EXPAND is a prospective, randomized, single-blind, intra-patient controlled, ...

ByIntersect ENT, Inc.


CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication

CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication

Intersect ENT®, Inc. (Nasdaq: XENT), a global ear, nose and throat (“ENT”) medical technology leader dedicated to transforming patient care, today announced that the Centers for Medicare and Medicaid Services (CMS) published an average selling price (ASP) for the Company’s SINUVA sinus implant, providing predictability, transparency, and confidence of reimbursement for ...

ByIntersect ENT, Inc.


PolyActiva successfully completes initial clinical trial with Latanoprost FA SR Ocular Implant delivering glaucoma treatment to patients over a six-month period

PolyActiva successfully completes initial clinical trial with Latanoprost FA SR Ocular Implant delivering glaucoma treatment to patients over a six-month period

Melbourne, 5 November 2020 - PolyActiva Pty Ltd, a clinical-stage Australian ophthalmology biopharmaceutical company, today announced it has successfully completed its Phase I clinical study for its lead candidate, the Latanoprost FA SR Ocular Implant. The device was well tolerated in all 8 patients with no significant safety findings. The study also showed that the implant persists for the ...

ByPolyActiva Pty Ltd.


PolyActiva appoints Tracy Valorie, ophthalmic industry expert and former Bausch + Lomb executive, to its Board of Directors

PolyActiva appoints Tracy Valorie, ophthalmic industry expert and former Bausch + Lomb executive, to its Board of Directors

Melbourne, Australia - 30 October 2020: PolyActiva Pty Ltd, a clinical-stage ophthalmology biopharmaceutical company, today announced the appointment of highly experienced ophthalmic industry expert, Tracy Valorie, as a new member to the company's Board of Directors. Ms Valorie is recognized in the industry for her success in building and leading high performing teams and for her ability to lead ...

ByPolyActiva Pty Ltd.


First U.S. Patient Treated in OASIS Clinical Trial of RENOVA iStim System for Overactive Bladder

First U.S. Patient Treated in OASIS Clinical Trial of RENOVA iStim System for Overactive Bladder

Clinical investigators in the OverActive Bladder Stimulation System Study (OASIS) of the RENOVA iStim system, Drs. Becky McCrery and Emily Kean at Adult Pediatric Urology & Urogynecology in Omaha implanted the first U.S. patient in this international clinical study. The RENOVA iStim system is an investigational device designed to reduce urinary urge leakage and improve OAB symptoms. ...

ByBlueWind Medical


Planmeca and Navigate Surgical Technologies Join Forces to Launch Innovative Solutions for Dental Im

Planmeca and Navigate Surgical Technologies Join Forces to Launch Innovative Solutions for Dental Im

Dental manufacturer Planmeca and Navigate Surgical Technologies (NST), a provider of real-time surgical navigation solutions, are pleased to announce their cooperation. This partnership aims to provide dental implant surgeons with technological innovations that will deliver enhanced patient outcomes through improved accuracy and precision, as well as through simplified digital workflows. Dynamic ...

ByNavigate Surgical Technologies Inc.


IlluminOss Medical Receives Clearance to Expand Clinical Indications in the U.S.

IlluminOss Medical Receives Clearance to Expand Clinical Indications in the U.S.

IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that the IlluminOss Photodynamic Bone Stabilization System has received additional clinical clearance and is now indicated by the U.S. Food and Drug Administration (FDA) for use in skeletally mature patients in the treatment of traumatic, ...

ByIlluminOss Medical, Inc.


Centric Medical Announces FDA 510(K) Clearance of the Foot and Ankle Plating System

Centric Medical Announces FDA 510(K) Clearance of the Foot and Ankle Plating System

Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the FDA 510(k) clearance of the new Foot and Ankle Plating System. This clearance offers multiple surgical solutions by Centric Medical, to be used in Foot & Ankle reconstruction procedures. The Centric Medical Foot and Ankle Plating ...

ByCentric Medical, LLC


IlluminOss Medical Granted FDA Marketing Clearance for the IlluminOss Bone Stabilization System

IlluminOss Medical Granted FDA Marketing Clearance for the IlluminOss Bone Stabilization System

IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received U.S. Food and Drug Administration (FDA) de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease. ...

ByIlluminOss Medical, Inc.


IlluminOss Medical Completes Enrollment for U.S. Clinical Trial Using Groundbreaking Photodynamic Bone Stabilization System

IlluminOss Medical Completes Enrollment for U.S. Clinical Trial Using Groundbreaking Photodynamic Bone Stabilization System

IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced it has completed enrollment in its first U.S. clinical trial towards FDA approval of its IlluminOss System, the world’s first and only system of its kind which supports the treatment of fractures using patient-specific intramedullary ...

ByIlluminOss Medical, Inc.

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