Posts by cstephenson@legacymedsearch.com
Shockwave Medical Announces That CMS Has Created New Codes for Intravascular Lithotripsy
Shockwave Medical, Inc., a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced today that the Centers for Medicare & Medicaid Services (CMS) has issued new codes for IVL procedures performed in peripheral arteries in both the hospital outpatient and inpatient settings. The new Healthcare Common Procedure…
Read More4WEB Medical Announces FDA 510(k) Clearance of Stand-Alone Anterior Lumbar Interbody Fusion Device
4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design that utilizes its proprietary Truss Implant Technology™, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Stand-Alone Anterior Lumbar Interbody Fusion Device (ASTS-SA). The new design allows fixation screws to…
Read MoreOcutrx’s Oculenz Advances from AR Headset to Full Surgery Visualization Theatre
The maker of breakthrough augmented-extended reality (AR/XR) glasses that provide a radically new surgical viewing experience for retinal surgeons and patients alike, is launching new technology that provides the most modern options for surgery visualization and to remove “pain” for surgeons to improve surgeries, Ocutrx Vision Technologies, LLC announced today. The Ocutrx OR-Bot™️ Surgery Visualization Theatre™ will…
Read MoreCMS Approves SINUVA Sinus Implant for Reimbursement with New C-Code and Pass-Through Payment Status
Intersect ENT, Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved SINUVA® (mometasone furoate) Sinus Implant for transitional pass-through payment status for reimbursement under the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center Payment…
Read MoreGTX medical Granted FDA Breakthrough Device Designation for Go-2 Targeted Epidural Spinal Stimulation (TESS) System
GTX medical (GTX), today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its implantable Go-2 system which was designed to promote the recovery of leg motor functions and neurological control in adults with spinal cord injuries (SCI) and paralysis. The Go-2 System provides Targeted Epidural Spinal Stimulation (TESS)…
Read MoreNuvaira Announces FDA Breakthrough Designation for AIRFLOW-3 Pivotal Trial Device
Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, has announced that its Nuvaira® Lung Denervation System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA). This program creates an expedited pathway for prioritized FDA review of devices that have potential to provide more effective treatment…
Read MoreVasQ External Support Awarded Breakthrough Device Designation by the FDA
The FDA has designated Laminate Medical’s VasQ™ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients as a Breakthrough Device. The FDA Breakthrough Device Program is intended to provide patients and doctors timely access to medical devices that are more effective than the current standard of care for life-threatening or irreversibly debilitating…
Read MoreFDA Clears Innovative Angioplasty Scoring and Cutting Platform
Transit Scientific announced the FDA cleared the XO Score® Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic and/or native arteriovenous hemodialysis fistula. Angioplasty is performed with expandable polymer balloon catheters to dilate stenosed, or narrowed, vessels. Calcified, fibrous, and/or resilient stenosis may require special scoring…
Read MoreTitan Medical Announces Development and License Agreements With Medtronic and Senior Secured Loan
Titan Medical Inc. (“Titan” or “Titan Medical”) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of single-port robotic surgical technologies, announces that it has entered into a development and license agreement with Medtronic plc (“Medtronic”) (NYSE: MDT) to further the development of robotic assisted surgical technologies, as well as…
Read MoreNoctrix Health granted FDA Breakthrough Device Designation for wearable Restless Legs Syndrome Therapy
Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its wearable NTX100 Neuromodulation therapy designed for the treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications. RLS is the second most common sleep disorder in…
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