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The CardioSTAT solution differentiates itself by being the most flexible solution available: physicians have a choice of multiple monitoring durations ranging from 24 hours to 14 days. Food and DrugAdministration (FDA) Clearance for CardioSTAT® appeared first on Legacy MedSearch | Medical Device Recruiters.
Food and DrugAdministration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. CEO of Cardio Flow, stated: “Cardio Flow is committed to providing meaningful solutions that directly address the needs of physicians and their PAD patients through innovative product development.
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.
In June this year, it was announced that the US Food and DrugAdministration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.
a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and DrugAdministration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. Aerin Medical Inc., offices in California and Texas.
Food and DrugAdministration for its Respiratory Health point of care test. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Visby Medical announced that it has received Emergency Use Authorization (EUA) from the U.S. About Visby Medical.
Food and DrugAdministration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Healthcare systems and physicians will also be able to use the Tasso+ device with compatible collection tubes to make determinations on blood chemistries for their patients and expand care access. Tasso, Inc.,
Food and DrugAdministration. The adoption of the Early Bird system is a testimony to physicians embracing the benefits of early bleed detection for their patients and practice.”. “We Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.
Food and DrugAdministration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Hyperfine, Inc., The Swoop® system received initial U.S.
a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and DrugAdministration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., Chief Executive Officer of SpectraWAVE.
In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and DrugAdministration (FDA) for marketing in the USA or other geographies.
Food and DrugAdministration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO ® Vascular Occlusion System. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Okami Medical Inc.,
Food and DrugAdministration (FDA) for 510(k) clearance. Inspira plans for the ALICE to be the first device to Integrate the HYLA Blood Sensor designed to be non-invasive, perform continuous measurements and alert physicians at real time of sudden changes in a patient’s specific key blood indicators.
Food and DrugAdministration market clearance for the ArthroFree System. 2015), and has raised more than $25M from institutional investors, family offices, and more than 70 physician champions. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.
Food and DrugAdministration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. According to Tyber Medical’s Senior Project Engineer Abe Perryman, physicians have responded favorably to the company’s new staple system. Press Release by: Tyber Medical.
Food and DrugAdministration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. For updates, follow Cytovale on LinkedIn and Twitter. Press Release by: Cytovale.
Food and DrugAdministration (FDA) 510(k) clearance for its FalloView device. The LCD screen on the handle of the device allows the physician to visualize internal patient anatomy in line with instrument insertion. Food and DrugAdministration (FDA) 510(k) clearance for its FalloView device.
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). Current and planned use cases for IntraOpVSP are expected to align to the needs of physicians across general, craniofacial and maxillofacial, neuro, orthopedic, plastic, thoracic and vascular surgery disciplines. Food and DrugAdministration cleared the software for use in 2022.
Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and DrugAdministration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. physicians the opportunity to treat their patients with this novel device.” Are you hiring?
Food and DrugAdministration (FDA) has cleared expanded Indications for Use for screening with FibroScan® , the non-invasive liver management technology by Echosens. Measurement interpretation has been expanded to all physicians with appropriate training.
Food and DrugAdministration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. “It’s estimated that anywhere from 2% to 53% of U.S.
Food and DrugAdministration (FDA) clearance, allowing users to robotically insert and steer the XACT ACE® Robotic System remotely from the control room. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Press Release by: XACT Robotics.
The US Food and DrugAdministration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test.
Food and DrugAdministration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt ® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). . CereVasc, Inc., Press Release by: CereVasc.
a leading US developer of next gen endoscope systems announces today the US Food and DrugAdministration (FDA) has granted 510(k) clearance of its novel integrated 360° field of view colonoscope. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Saneso Inc.,
a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and DrugAdministration (FDA) for its VisAble.IO Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.
Food and DrugAdministration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. BabySat is a step forward in solving some of these exact challenges by bringing real-time medical grade infant monitoring into the home, while under the supervision of a physician.
Food and DrugAdministration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). ” About Innoblative Innoblative is a medical device company dedicated to innovating advanced-energy solutions that improve the way physicians treat breast cancer and other soft tissue diseases.
Food & DrugAdministration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System. Utilizing expandable technology and robust plating options, TruLift Lateral and Lateral Plate System provide physicians with unique possibilities for their patient care. Press Release by: Life Spine.
Food and DrugAdministration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.
Food and DrugAdministration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites. CereVasc, Inc.,
Food and DrugAdministration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. Today millions of Americans use DOACs, a highly effective and widely used drug for managing atrial fibrillation and deep vein thrombosis. DOACs can elevate bleeding risk and complicate emergency care.
Food and DrugAdministration (FDA) 510(k) clearance of its Zoom RDL Radial Access System, the company’s latest innovation in elevating stroke care and the first radial access platform developed specifically for ischemic stroke treatment. Imperative Care, Inc., announced U.S. The Zoom RDL provided.088”
Food and DrugAdministration (FDA) has granted 510(k) clearance to the MedWand,” shared MedWand CEO and Co-Founder, Robert Rose. “As MedWand Mobile Clinic – Designed for physician or home visits and remote patient monitoring applications. To request a demo today visit www.medwand.com. “I MedWand Solutions, Inc.
“We are addressing the observations by so many physicians that there is a vast unmet need for a better way to definitively treat this female population.” Food and DrugAdministration). Food and DrugAdministration (FDA) for UroActive.
The US Food and DrugAdministration has approved the use of iTFlow® in blood flow analysis. Combining advanced algorithms and image analysis techniques assists physicians and healthcare professionals in diagnosis and treatment planning. appeared first on Legacy MedSearch | Medical Device Recruiters.
Food & DrugAdministration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. OpSens Inc. , Press Release by: OpSens Inc.
Food and DrugAdministration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. was achieved indicating that physicians can precisely target and destroy liver tissue and unresectable liver tumors.
Food and DrugAdministration (FDA) to market the Blackhawk ® Ti 3D Printed Cervical Spacer System with standalone clearance. The post ChoiceSpine® Announces Standalone Indication for Blackhawk® Ti 3D Printed Cervical Spacer System appeared first on Legacy MedSearch | Medical Device Recruiters.
Food and DrugAdministration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). million Americans are affected by PAD. Endovascular treatments are feasible in selected patients but have limited patency.
Food and DrugAdministration (FDA) 510(k) clearance for its Laguna Clot Retriever System and its Malibu Aspiration Catheter System for use in the peripheral vasculature. We are grateful to our physician advisors, who play a key role in shaping these solutions.” Innova Vascular, Inc.
End users of Clarify Trials are typically study team members involved in the design of studies and strategies for recruiting participants, says Drouin. Local efforts emerged where, for example, physicians might interview patients about potential problems getting to medical appointments and, if need be, provide transportation services.
Food and DrugAdministration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. With HFX iQ, our goal is to provide physicians and patients the personalization needed to achieve and maintain the best possible long-term outcomes. We believe HFX iQ represents the future of SCS therapy.”
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