innovative medical device News
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Bionix Development Co. Appoints Dorian Drake International Inc. as Export Sales Representative
Bionix Development Corporation, a leader in the development, manufacturing and marketing of innovative medical devices and equipment, has appointed Dorian Drake International Inc. as its export sales representative for its Medical Technologies products division in select Latin American and Caribbean markets. Dorian Drake will act as Bionix’s sales and marketing arm in its sales ...
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The Oplight™ In The Times
This week, Clear Surgical and its innovative medical device, the OpLight™ were featured in a special article to commemorate 70 years of the NHS in Scotland. On the 5th of July 2018, the National Health Service (NHS) celebrated its 70th anniversary with events up and down the length and breadth of the UK. This milestone was the perfect opportunity to celebrate and give thanks to all that ...
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Mundomedis Portfolio Company Tennessee Medical Innovations INC, USA, Announces Acquisition of the Assets of Insightra Medical INC.
Mundomedis announced it has closed on the acquisition by its wholly-owned portfolio company, Tennessee Medical Innovations INC. (TNMI), of substantially all assets of Insightra Medical Inc., as a US-based medical device manufacturer. Insightra Medical was founded in 2001 and develops, manufactures and markets innovative medical devices for orthopedic, cardiovascular and hernia related medical ...
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EMOSIS reinforces its Intellectual Property and scientific expertise
The French innovative Medical Device start-up Emosis, specializing in cytomolecular diagnostics of thrombosis and hemostasis disorders, is reinforcing its intellectual property on HIT Confirm®, Emosis first test kit which was recently launched in Europe (CE Mark). The company was granted a US patent “Platelet Analysis System” (US10, 012,658 B2), and the PCT of the patent ...
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The Centers for Medicare and Medicaid (CMS) announced the MCIT pathway to provide national Medicare coverage for FDA Breakthrough Devices and Diagnostic
The Centers for Medicaid and Medicare (CMS) announced the establishment of the MCIT (Medicare Coverage of Innovative Technology) pathway, which is designed to provide coverage and access to new, innovative medical devices and diagnostics which have received FDA Breakthrough Device Designation to Medicare beneficiaries nationwide. Through this pathway, Breakthrough devices will automatically be ...
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Proa Medical, Inc. Receives China and Russia Patent Grants for its First Device for Women’s Health
Proa Medical, Inc., developer of innovative and practical medical devices for women’s health, today announced that it has been granted patents in China and Russia covering the company’s first product, the Brella Vaginal Retractor. (Proa Medical was granted a United States patent covering the Brella Vaginal Retractor from the United States Patent and Trademark Office on June 9, 2015.) ...
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Injectsense adds experts to Medical advisory board
Injectsense, Inc. an innovative medical device firm that develops sensor-enabled digital health systems to measure therapy effectiveness, announced today additional members of its medical advisory board. The board, which includes world renowned specialists and surgeons in the ophthalmic field, provides valuable feedback on device requirements, procedures, risk mitigation, and regulatory issues. ...
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TriMedika Growth Ahead of US Market Entry
Pioneers of innovative medical devices, including a leading non-contact thermometer, TriMedika has delivered 100% year-on-year growth since launching in 2016. TriMedika has also seen significant uplift in 2020/2021, increasing staff from four to 14. New hires include a five strong dedicated Digital Marketing Team, a Training and Quality Projects Manager, Office Manager, Sales Coordinator and ...
By TriMedika
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Lumendi Introduces EZ Glide Hydrophilic Coating for Its DiLumen Endoluminal Interventional Platform (EIP)
Connecticut-based medical device innovator Lumendi, LLC (www.lumendi.com) has launched EZ Glide, a proprietary hydrophilic coating applied to the inner sheath of its DiLumen EIP, a double-balloon endoluminal device that aims to safely improve the navigation of the endoscope through the bowel, create a stabilizing therapeutic zone inside the colon during endoluminal interventions, ...
By Lumendi Ltd.
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Proa Medical and Pelv-Ice to Merge
Proa Medical, Inc., the creator of the Brella® Vaginal Retractor, a single-use retractor with a built-in light source designed to provide optimal visualization and access during repair of the vaginal walls and perineum, and other innovative, high potential medical devices for women’s pelvic health, has entered into a Merger Agreement with Pelv-Ice, LLC, the first company formed to ...
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KiOmed Pharma appoints seasoned industry executives and expands its board of directors
KiOmed Pharma announces the appointment of two seasoned biotech executives: Dr Pierre Rigaux, MD, PhD is joining its Board of Directors, and Dr Mathias Schifflers, MD is appointed Chief Medical Officer and joins its executive management team “We are absolutely delighted to announce the appointment of Dr Pierre Rigaux to our Board of Directors. Pierre is an extremely well-regarded executive ...
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BioVentrix Receives 2021 NUB Status 1 Reimbursement Renewal in Germany for the Revivent TC TransCatheter Ventricular Enhancement System
BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter based Ventricular Restoration (TCVR), today announced that the German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 reimbursement designation in Germany for the Revivent TC™ TransCatheter Ventricular Enhancement System used in LIVE™ ...
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CoNextions Inc. Announces FDA 510(k) Clearance of Coronet System, a Revolutionary Tenodesis Product
CoNextions Inc. (www.conextionsmed.com) announced today that it received a 510(k) clearance (K200028) from the U.S. Food and Drug Administration (FDA) for CoronetTM System, a tenodesis product intended for the fixation of tissue to bone and tissue to tissue. The Coronet’s novel design improves the soft tissue fixation strength of these repairs compared to conventional suture repairs. A ...
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Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology
Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) who remain ...
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Regenerative Medicine Made In Italy
Fortunately, not all brains are fleeing Italy. And when they come together the result is very often of excellence. A striking example is the TMR (registered trademark and acronym of Magnetic Resonance Therapeutic), an innovative medical device that provides great benefits for our health and well-being. The TMR is a 100% Made in Italy device, made by the Thereson company, the result of a long ...
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FDA Approves Expanded Sterilization and Disinfectant Methods for the LUMINELLE® DTx System
UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the Company's expanded reprocessing procedures for use with the LUMINELLE DTx System. This expansion will allow the LUMINELLE DTx System to be more fully utilized in broader settings such as Hospital Systems and Outpatient Surgical Centers. It will also support ...
By LUMINELLE
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With Policy Support, the Market for Surgical Robots Grows
Recently, the Ministry of Industry and Information Technology, the National Health Commission and other 17 departments jointly issued the "robot" application action implementation plan to encourage the development of surgery, auxiliary examination, auxiliary rounds, intensive care, rehabilitation and other medical robot products, "robot The "robot" has ushered in a new round of development ...
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AventaMed selected as Test Case for RWE by NESTcc
The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announces twelve new Test-Cases which leverage Real-World Evidence (RWE) and address key priorities for medical device stakeholders. These Test-Cases are intended to accelerate NESTcc’s progress and provide proof of concept for NESTcc’s ...
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Second Heart Assist to Present Clinical Data at American Society for Artificial Internal Organs 66th Annual Conference
Salt Lake City, UT (April 30th, 2020) – Following blind peer review, Second Heart Assist’s clinical data presentation has been selected for oral presentation at the American Society of Artificial Organs (ASAIO) 66th annual conference, scheduled to be held entirely virtual by video June 10th-13th, 2020. The Second Heart Assist abstract will be published in the ASAIO Journal and will ...
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Flosonics Medical receives $500,000 in federal funding to accelerate the integration of FloPatch in hospitals across North America
The Government of Canada investment will help Flosonics Medical develop the IT infrastructure required for commercialization and create five new jobs in Greater Sudbury Flosonics Medical is pleased to announce that it has received a $500,000 investment from the Government of Canada to accelerate the integration of FloPatch in hospitals across North America. The repayable investment will help ...
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