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Food and DrugAdministration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. “Enable’s purpose is to redefine drug delivery for the benefit of patients. .
Medical device and technology company Lazurite has received recognition from Medical Device Network Excellence Awards & Rankings, one of the largest, most prestigious, and widely recognized programs in the industry. All Commended companies will be entered into the Medical Device Network Awards at the end of the year. “The
Food and DrugAdministration (FDA). ” Please visit the link below to learn more about POLARIS AR and STELLAR Knee, and to connect with a sales or POLARIS AR team representative: [link] ABOUT POLARIS AR POLARIS AR is a Miami based startup whose mission is to develop a new class of Mixed Reality surgical technology.
Food and DrugAdministration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. Food and DrugAdministration (FDA) 510(k) Clearance for its FreedomFlow® Orbital Atherectomy Peripheral Platform Press Release by: Cardio Flow, Inc. Cardio Flow, Inc. , Announces U.S.
EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and DrugAdministration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.
Food & DrugAdministration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. Food & DrugAdministration (FDA). CurvaFix, Inc., The new 7.5mm device is designed to simplify surgery and to provide strong, stable, curved fixation in smaller patients.
IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.
Food and DrugAdministration for its Respiratory Health point of care test. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.
Food and DrugAdministration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. Scott Kraus, Vice President of Sales & Market for Cardio Flow, commented, “Cardio Flow is encouraged by the initial feedback from Dr. Mustapha, who is a recognized leader in the treatment of PAD and critical limb ischemia (CLI).
MicroPort Navibot has received 510(K) clearance from the Food and DrugAdministration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. Our clients include both blue-chip companies and innovative startups within the MedTech space.
Food and DrugAdministration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. Our clients include both blue-chip companies and innovative startups within the MedTech space.
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Food and DrugAdministration (FDA) 510(k) clearance for the Flex-Thread Ulna Intramedullary (IM) Nail System. Conventus Flower Orthopedics, an innovation-driven medical technology company, announced they have received U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.
Activ Surgical received 501(k)-clearance for ActivSight by the Food and DrugAdministration (FDA) in the United States in 2021. To date, multiple major hospital networks across the U.S. This is a proud day in Activ Surgical’s history.”.
A strong medical sales team is essential for success in the healthcare industry. These teams not only drive product sales but also build lasting relationships with healthcare professionals, helping deliver innovative medical solutions to those who need them most. Let Us Build You A Medical Sales Machine Today!
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Food and DrugAdministration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. announced that its head-to-toe trauma imaging solution, the BodyTom® 64 Point-of-Care Mobile Computed Tomography (CT) Scanner, has received 510(k) clearance from the U.S.
Food and DrugAdministration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. Axonics, Inc., a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, announced that the U.S.
Food and DrugAdministration (FDA). Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs. ChroniSense Medical Ltd.
The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”
The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and DrugAdministration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. De-risking drug launch. This figure represents a 2.4% Insourcing vs outsourcing.
Food and DrugAdministration (FDA) for 510(k) clearance. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.
Food and DrugAdministration (FDA). Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.
Food and DrugAdministration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.
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Medinol today announced United States Food and DrugAdministration (FDA) approval for the EluNIR-PERL drug-eluting stent (DES) for the treatment of coronary artery disease. EluNIR-PERL builds upon the proven performance and clinical data of the EluNIR DES system. “We are pleased to bring technologies to the U.S.
Food and DrugAdministration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. On March 5, the U.S. Following this announcement, Dexcom’s shares experienced a 2.2% increase in extended trading.
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Food and DrugAdministration. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs. Saranas, Inc.
Food and DrugAdministration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System.
Food and DrugAdministration (FDA). Food and DrugAdministration cleared the software for use in 2022. Xironetic, an early-stage healthcare technology company, today announced its IntraOpVSP augmented reality (AR) visualization software for complex surgeries has received clearance from the U.S.
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a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and DrugAdministration (FDA). Lumicell, Inc., Are you hiring?
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Food and DrugAdministration (FDA) has granted the first marketing clearance for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers. RefleXion Medical , a therapeutic oncology company, announced the U.S.
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