Medical Device Industry

Found 13,357 articles

• Asensus Surgical, Inc. to Present at the 42nd Annual J.P. Morgan Healthcare Conference

  1/3/2024

  Asensus Surgical, Inc. announced that the management team will participate and present at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024 at 3:00pm EST.

• LumiThera Provides Update on FDA Review of Valeda Treatment for Dry AMD Patients

  1/3/2024

  LumiThera Inc. announced an update on the regulatory status of the Valeda® Light Delivery System.

• Rehabtronics Receives Certification for Medical Device Single Audit Program (MDSAP), Expediting Global Commercialization of its Upper Limb Rehabilitation Devices

  1/3/2024

  Rehabtronics Inc announces it has successfully upgraded its ISO13485:2016 quality certification to include the internationally-recognized Medical Device Single Audit Program standard.

• Sofwave Medical Receives 510(k) Marketing Clearance for Pure Impact™ Strength and Muscle Toning Body Module Utilizing PlyoPulse™ EMS Technology

  1/3/2024

  Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, announced clearance by the U.S. Food and Drug Administration (FDA) for the Company’s 510(k) premarket notification submission to market Pure Impact™ utilizing PlyoPulse™ EMS (“electromagnetic stimulation”) technology in the United States.

• Cardionomic Announces Enrollment Completion in the STIM-ADHF and STOP-ADHF Pilot Studies

  1/3/2024

  Cardionomic, Inc., a Minneapolis medical device company, is pleased to announce the completion of enrollment in both their STIM-ADHF and STOP-ADHF pilot studies.

• Cinesteam® Uses Cinnamon to Manage Wound Malodors

  1/3/2024

  One of the quiet struggles that many medical patients face is the need to manage unpleasant smells created by wounds.

• Sequana Medical granted US CPT® III reimbursement codes for alfapump® system

  1/3/2024

  Sequana Medical NV announces that the American Medical Association has issued six new Category III Current Procedural Terminology codes for the alfapump system, an important step in facilitating reimbursement for the Company’s innovative medical device for the treatment of recurrent or refractory ascites due to liver cirrhosis.

• Catheter Precision, Inc. (VTAK) Receives Additional Patents for LockeT in Great Britain and the European Market

  1/2/2024

  Catheter Precision, Inc. announced that Great Britain and the European Market have allowed two new patents, further strengthening the company's IP position for its LockeT product line.

• CardioMech Raises $13m in Heavily Oversubscribed Round for Its Transcatheter Mitral Chordal Repair Technology

  1/2/2024

  Norway-based CardioMech AS, a medical device company developing a transfemoral, transseptally delivered mitral valve chordal repair technology in Fridley, MN, announced it has closed on $13M in fresh capital.

• GLUCOTRACK ANNOUNCES EARLY ACCURACY DATA FOR ITS IMPLANTABLE CONTINUOUS GLUCOSE MONITOR

  1/2/2024

  GlucoTrack, Inc. (Nasdaq: GCTK) (“GlucoTrack” or the “Company”), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, provides, updates on initial and long-term preclinical testing for the implantable Continuous Blood Glucose Monitor™ (CBGM).

• Pulnovo Medical Announces PADN Receives FDA HUD Designation and US CMS Medicare Coverage Code and NMPA Approval

  1/2/2024

  Pulnovo Medical Limited recently announced that it has successfully obtained Humanitarian Use Device (HUD) designation from the US FDA and approval from China's National Drug Administration (NMPA) for the PADN Catheter and Generator.

• Senseonics Holdings, Inc. Announces Business Updates - Jan 02, 2024

  1/2/2024

  Senseonics Holdings, Inc., a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring systems for people with diabetes, announced operational and financial business updates.

• SeaStar Medical Updates Subject Enrollment in its Pivotal Trial with the Selective Cytopheretic Device in Adults with Acute Kidney Injury

  12/28/2023

  SeaStar Medical Holding Corporation announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device extracorporeal therapy in critically ill adults with acute kidney injury requiring continuous kidney replacement therapy.

• Inspira™ Technologies Closes on $3.88 Million Registered Direct Offering

  12/28/2023

  Inspira Technologies OXY BHN Ltd. announces the closing of its previously announced registered direct offering of 3,031,250 ordinary shares, at a purchase price of $1.28 per ordinary share.

• Sight Sciences Announces Withdrawal of Final LCDs on Micro-Invasive Glaucoma Surgery from Five Medicare Administrative Contractors

  12/28/2023

  Sight Sciences, Inc. announced by five Medicare Administrative Contractors to withdraw their final local coverage determinations for Micro-Invasive Glaucoma Surgery that were scheduled to take effect on January 29, 2024.

• HR Pharmaceuticals, Inc. receives exclusive commercialization rights to Poiesis Medical's Dual Balloon Catheter technology in North America

  12/28/2023

  HR Pharmaceuticals, Inc. announced that they have entered into an Exclusive Commercial Agreement with Poiesis Medical LLC, under which HRP will license Poiesis's Dual Balloon Catheter.

• Neurolief Announces Strategic Equity Investment by Sawai Group Holdings

  12/28/2023

  Neurolief, a global leader in medical devices delivering groundbreaking neurotechnology innovations for the treatment of Neurological and Neuropsychiatric disorders, is pleased to announce a strategic equity investment from Sawai Group Holdings Co., Ltd.

• Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis

  12/28/2023

  Sequana Medical NV announces that it has submitted a Premarket Approval application to the US Food and Drug Administration for alfapump, the Company’s fully implantable, wirelessly charged device for patients with recurrent or refractory ascites due to liver cirrhosis.

• RxSight, Inc. to Present at the 42nd Annual J.P. Morgan Healthcare Conference

  12/27/2023

  RxSight, Inc., an ophthalmic medical device company dedicated to providing high-quality customized vision to patients following cataract surgery, announced plans to participate in the upcoming J.P. Morgan Healthcare Conference.

• Beyond Cancer™ Phase 1 Study Clears Cohort 1 in Patients with Advanced Relapsed or Refractory Unresectable Primary or Metastatic Cutaneous or Subcutaneous Solid Tumors

  12/27/2023

  Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. and a clinical stage biotechnology company developing ultra-high concentration nitric oxide as an immunotherapeutic for solid tumors, announced that the Phase 1 Study evaluating UNO in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors has cleared the first cohort of 25,000 ppm single dose UNO by the Safety Review Committee with no reported dose limiting toxicities.