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SEPTEMBER 5, 2023

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 Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., “We are excited to receive 510(k) clearance for our VisAble.IO The BioTrace.IO

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MARCH 22, 2023

Food and Drug Administration (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.

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NOVEMBER 14, 2022

Food and Drug Administration (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 Drug Administration cleared the software for use in 2022.

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FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc.,

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OCTOBER 30, 2023

Medinol today announced United States Food and Drug Administration (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. For more information, see www.medinol.com. Are you hiring?

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JUNE 20, 2023

Food and Drug Administration (“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.

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OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.

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JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions.

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AUGUST 29, 2022

Food and Drug Administration (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. Are you hiring?

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APRIL 27, 2023

Food and Drug Administration (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. Are you hiring?

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AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement 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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AUGUST 23, 2023

Food and Drug Administration (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. Otsuka Medical Devices”) announce the U.S.

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SEPTEMBER 18, 2023

Food and Drug Administration (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., Are you hiring?

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JANUARY 18, 2023

Food and Drug Administration (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. Press Release by: Cytovale. Are you hiring?

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JANUARY 4, 2023

Food and Drug Administration (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”

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DECEMBER 16, 2022

Food & Drug Administration (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.

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MARCH 15, 2023

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring.

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Food and Drug Administration FDA Recruitment Physicians 97

European Pharmaceutical Review

JANUARY 19, 2023

The contribution will enable the programme to reach additional physicians and medical students, further expanding the initiative that aims to extend the reach of clinical trials in underserved patient populations in US communities. The Winn Award Program has so far trained 114 early-stage investigator physicians.

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JUNE 9, 2023

Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). “We are delighted to receive FDA approval of the DETOUR System,” said Matt Thompson, MD, President, and CEO of Endologix. million Americans are affected by PAD.

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SEPTEMBER 20, 2022

Food & Drug Administration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. For OpSens, FDA clearance is a key milestone and an achievement, introducing an entirely new category of innovation to the structural heart device market segment.

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APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery. Pacifico, Founding President and Chief Executive Officer of Abyrx.

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OCTOBER 13, 2022

Food and Drug Administration (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.” Are you hiring?

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OCTOBER 17, 2023

Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. . Are you hiring?

Food and Drug Administration 52

Food and Drug Administration Recruitment FDA Management 52

PM360

AUGUST 9, 2022

Brand Beat: Juul Fights FDA Ban. Shortly after banning Juul from selling its products, the FDA placed a hold on its decision in order to review the company’s case more closely. however, the company is required to prove to the FDA that their e-cigarettes in fact benefit the public. FDA Update. Drug Approvals.

Healthcare 52

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JULY 21, 2023

“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 Drug Administration). Food and Drug Administration (FDA) for UroActive. STeP participation does not imply product authorization.

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SEPTEMBER 20, 2023

Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue Imaging 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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Pharma Marketing Network

JULY 10, 2023

Direct-to-physician (DTP) advertising: DTP advertising is advertising that is directed to healthcare providers. These challenges include: Regulation: Pharmaceutical marketing is heavily regulated by government agencies, such as the Food and Drug Administration (FDA) in the United States.

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OCTOBER 18, 2023

Food and Drug Administration (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.

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APRIL 6, 2023

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. Icentia Inc., “This approval marks a key milestone for our company.

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MAY 23, 2022

Developed by Cleveland-based Lazurite Holdings LLC, ArthroFree recently became the first wireless camera for arthroscopy and general endoscopy to receive market clearance from the Food and Drug Administration. He is a former assistant team physician to The Cleveland Guardians and Cleveland Cavaliers. The Cleveland-based company (est.

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SEPTEMBER 12, 2022

a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. Aerin Medical Inc., Aerin Medical is a privately held, venture-backed company, with U.S.

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JULY 25, 2023

The US Food and Drug Administration 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. Are you hiring?

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SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. This action is part of the FDA’s ongoing effort to ensure the safe and effective use of blood lancets in the home and health care settings. Tasso, Inc., For more information, please visit www.tassoinc.com.

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AUGUST 22, 2022

Food and Drug Administration (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 I am happy to share that the U.S.

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JUNE 7, 2023

Food and Drug Administration (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. CEO of Innova Vascular. Are you hiring?

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DECEMBER 21, 2022

Food and Drug Administration (FDA) for 510(k) clearance. If FDA clearance is obtained, the ALICE device production line will be extended for Low-Rate Initial Production (LWRIP), which is an important operational stage in developing infrastructure to support serial manufacturing, quality control and shipping. Are you hiring?

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JUNE 17, 2022

Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO ® Vascular Occlusion System. LOBO-3 and LOBO-5, both previously FDA cleared, are intended for use in 1.5 Okami Medical Inc., Okami Medical – LOBO Vascular Occlusion System.

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Medical FDA Food and Drug Administration Recruitment 90