Medical Monitoring News
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Hologic Expands Ultrasound Portfolio to Address Full Spectrum of Imaging Needs
MARLBOROUGH, Mass. January 28, 2021 – Hologic, Inc. (Nasdaq: HOLX) announced today the expansion of its ultrasound portfolio with the launch of the new SuperSonic™ MACH™ 20 ultrasound system. Hologic now offers three tiers of ultrasound technology, ensuring more facilities have access to customized ultrasound solutions to address their unique imaging needs. Each of the systems ...
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Orion presented the Results of our Successful Phase 1 Clinical Trial at the HIV Research for Prevention Conference
Orion Biotechnology Canada Ltd., a clinical stage pharmaceutical company focused on precision engineering small protein therapeutics, today announced that they will be presenting the results of their Phase 1 study of OB-002H at the HIVR4P virtual meeting (https://www.hivr4p.org/). The OB-002H-101 Phase 1 study was a first-in-man trial designed to evaluate the safety, acceptability, and ...
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BenevolentAI and AstraZeneca achieve collaboration milestone with novel AI-generated chronic kidney disease target
BenevolentAI today announced that the biopharmaceutical company AstraZeneca has selected a novel chronic kidney disease (CKD) target to advance to its drug development portfolio, making it the first AI-generated target from the collaboration to enter the Company’s portfolio. Novel chronic kidney disease (CKD) target from the partnership enters AstraZeneca’s portfolio AI-generated ...
By Benevolent
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Valcare Medical Announces First-in-Human Transseptal Implant of the AMEND Annuloplasty Ring for Mitral Valve Repair
Valcare Medical Ltd. developer of transcatheter mitral and tricuspid valve repair and replacement solutions, announces that it has successfully completed its first-in-human transseptal delivery of the AMEND™ annuloplasty ring. The transseptal AMEND procedure was performed at the Schulich Heart Centre at Sunnybrook Health Sciences Centre in Toronto, under the Health Canada Special Access ...
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ELIXIR MEDICAL ANNOUNCES OUTSTANDING 24-MONTH DATA FOR DYNAMX CORONARY BIOADAPTOR SYSTEM, DEMONSTRATING STRONG SAFETY WITH NO TARGET LESION REVASCULARIZATION, MYOCARDIAL INFARCTION OR THROMBOSIS THROUGH 24 MONTHS
MILPITAS, Calif. – January 27, 2020 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced the 24-month clinical results for the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology. The results were presented at the 30th Annual Live Interventions in Vascular Endotherapy ...
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Gesynta Pharma initiates Phase II study of its first-in-class drug candidate GS-248 in patients with systemic sclerosis
Gesynta Pharma AB today announced that the first patients have been dosed in a Phase II study of its oral drug candidate GS-248 in patients with systemic sclerosis - a debilitating autoimmune disease that causes serious damage to the microvasculature. This proof-of-concept study will investigate the safety of GS-248 and its efficacy on Raynaud's phenomenon and peripheral blood flow in this ...
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SoundBite Medical Solutions Announces First Use of its Novel 0.014” Active Wire to Successfully Treat Calcified Below-The-Knee CTOs
Soundbite Medical Solutions Inc. (SBMS) announced today the first use of its novel Active Wire 0.014” platform in the successful treatment of patients suffering from critical limb ischemia (CLI) with heavily calcified below-the-knee (BTK) chronic total occlusions (CTO). The procedures were performed by Professor Marianne Brodmann, Head of the Clinical Division of Angiology, Department of ...
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Kardium announces $115M in new financing for innovative atrial fibrillation treatment
VANCOUVER, British Columbia – Kardium Inc., developer of the Globe® Mapping and Ablation System for the treatment of atrial fibrillation, has raised US $115 million in a new financing round. The round is led by Fidelity Management & Research Company LLC., together with follow-on participation by funds and accounts advised by T. Rowe Price Associates, Inc. The new financing will be ...
By Kardium Inc.
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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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FDA Approves Theranica`s Nerivio® for Acute Treatment of Migraine in Adolescents
Theranica, a prescribed digital therapeutics (PDT) company developing advanced electroceuticals for migraine and other pain conditions, today announced that its Nerivio® therapeutic device has received the Food and Drug Administration clearance to market for an expanded indication for acute treatment of episodic or chronic migraine in people 12 years and older. The use of the device in the ...
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Fameco is hiring!
Fameco is looking for a Flexible Endoscopy Service Engineer for joining our Technical Team. You have a significant experience in maintenance and repair of flexible endoscopes of the major brands (Fujinon, Olympus, Pentax)? You are interested in the second-hand field and wish to take part in the great adventure of refurbishing? You are a problem solver and able to work autonomously? Do not ...
By Fameco
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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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Lyra Therapeutics Provides Corporate Update and Anticipated Milestones for 2021
Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases, today provided a corporate update and anticipated milestones for 2021. Corporate Update & Anticipated Milestones for 2021 LYR-210: ...
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NeuroSigma Successfully Obtains HCPCS Codes from CMS for the Monarch eTNS System
NeuroSigma, Inc., a Los Angeles-based bioelectronics company that is commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders, announces that the Centers for Medicare & Medicaid Services ("CMS") is establishing two new Level II Healthcare Common Procedure Coding System ("HCPCS") codes for the Monarch eTNS System®, effective ...
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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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Ncardia and BlueRock Therapeutics Announce Collaboration Agreement and Licensing of Process Development Technologies for the Manufacture of iPSC-derived Cardiomyocytes
Ncardia and BlueRock Therapeutics today announced an agreement covering process development technologies for the manufacture of induced pluripotent stem cell (iPSC)-derived cardiomyocytes. Under the terms of the agreement, Bluerock gains access to Ncardia’s large-scale production processes and intellectual property for the production of iPSC-derived cardiomyocytes for therapeutic use. ...
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Meissa Announces 1st Dosing in Phase 2 Study of Intranasal Live Attenuated Vaccine Candidate for RSV
- The randomized, double-blind, placebo-controlled challenge study is designed to evaluate safety and prophylactic efficacy of MV-012-968 against symptomatic respiratory syncytial virus (RSV) - Previous clinical data shows MV-012-968 is well-tolerated, heavily attenuated, and induces an RSV-specific mucosal IgA response in healthy seropositive adults and pediatric participants REDWOOD ...
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Saluda Medical Announces Highlights from 2021 North American Neuromodulation Society (NANS) Meeting
Saluda Medical Pty Limited (“Saluda Medical”), the market leader in the development of closed-loop spinal cord stimulation for the treatment of chronic pain, announced scientific highlights from the 2021 North American Neuromodulation Society (NANS 2021) Virtual Meeting, including real-world European commercial results and sub-analyses of 24-month and 12-month clinical data from the ...
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TeraRecon CEO Jeff Sorenson To Depart, Dr. Romesh Wadhwani To Serve As Interim CEO
TeraRecon announced today that Jeff Sorenson is stepping down from his role as chief executive officer. SymphonyAI Chairman, Dr. Romesh Wadhwani will assume the role of interim CEO while a search for a replacement CEO is underway. During his nearly 15-year tenure at TeraRecon, Sorenson was the driving force behind the company’s accelerated growth and innovation and firmly established ...
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Neurent Medical Closes $25 Million Series B Funding to Advance Innovative Chronic Rhinitis Treatment
GALWAY, Ireland–(BUSINESS WIRE)–Neurent Medical, a company pioneering innovative treatments for chronic inflammatory sino-nasal diseases, today announced it has closed a $25 million Series B financing. The round was led by new investor LSP, from its LSP HEF-2 fund, and co-led by Atlantic Bridge, investing from its Growth Fund IV. Fountain Healthcare Partners also participated as a ...
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