Legacy MEDSearch

NOVEMBER 3, 2023

Food and Drug Administration (FDA). FOOD AND DRUG ADMINISTRATION FOR STELLAR KNEE Press Release by: POLARISAR Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Food and Drug Administration for Stellar Knee appeared first on Legacy MedSearch | Medical Device Recruiters.

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Legacy MEDSearch

DECEMBER 12, 2022

This most recent FDA 510(k) clearance extends the system’s previous FDA clearances and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station. For more information, please visit www.irras.com. Are you hiring?

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Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. About NeuroOne.

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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Legacy MEDSearch

OCTOBER 24, 2023

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. “The FDA’s Breakthrough Device Designation is a testament to the potential of our technology to address a critical unmet need in interventional cardiology,” said Dr. Mehran Khorsandi, CEO of Advanced Bifurcation Systems.

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SEPTEMBER 27, 2022

Food and Drug Administration (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. See Full Press Release at the Source: Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia.

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OCTOBER 10, 2023

Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced today that it has received clearance from the Food and Drug Administration for its Hammerdesis Interphalangeal Fusion System. This is a truly disruptive technology in a crowded area. Are you hiring?

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Legacy MEDSearch

NOVEMBER 1, 2022

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. Food & Drug Administration (FDA). See Full Press Release at the Source: CurvaFix Receives FDA Clearance for Smaller-diameter, Intramedullary Implant for Pelvic Fracture Fixation.

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Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. Are you hiring?

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Legacy MEDSearch

JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. executive vice president, chief marketing and strategy officer of Axonics. Axonics, Inc., Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. Are you hiring?

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Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

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Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. Inspira aims to revolutionize the medical ventilation and oxygenation market by delivering next-generation superior treatment, that will reduce the reliance on mechanical ventilation. Are you hiring?

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Legacy MEDSearch

MARCH 1, 2024

Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. The FDA’s approval was largely based on data from the AGENT IDE trial, which compared treatment with the AGENT DCB to traditional balloon angioplasty. Are you hiring?

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Legacy MEDSearch

MARCH 27, 2023

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. Receives FDA Clearance For Its FalloView™ Falloposcope appeared first on Legacy MedSearch | Medical Device Recruiters. FemDx Medsystems, Inc., Are you hiring?

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JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. See Full Press Release at the Source: ABM RESPIRATORY CARE ANNOUNCES THE FDA CLEARANCE OF THE BIWAZE CLEAR SYSTEM. For more information visit, www.abmrc.com. . Press Release by: ABM Respiratory Care. Are you hiring?

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DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today. market today.

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Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

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Legacy MEDSearch

NOVEMBER 2, 2023

Food and Drug Administration (FDA) to market the SOLACE Sacroiliac Fixation System with proprietary NANOACTIV surface technology and compatibility with StealthStation ® Navigation. The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.

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NOVEMBER 14, 2022

Food and Drug Administration (FDA). Food and Drug Administration cleared the software for use in 2022. See Full Press Release at the Source: Xironetic Receives FDA Clearance for Augmented Reality Surgical Software. Xironetic is headquartered in Oklahoma City. Follow our progress at [link] and connect with us on LinkedIn.

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JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. Cresilon’s mission is to save lives.

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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Legacy MEDSearch

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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Legacy MEDSearch

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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Legacy MEDSearch

OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). It additionally signals that the FDA is already thinking about future pandemic preparedness, something we are keen to partner on with them and the medical community.” “I RAC & Chief Regulatory Officer for ExThera.

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AUGUST 22, 2023

Food and Drug Administration (FDA) clearance for its MARS platform. The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. “With this FDA clearance, we eagerly anticipate making a substantial impact across the value chain.”

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Legacy MEDSearch

MARCH 2, 2023

Apyx Medical Corporation (NASDAQ:APYX) , the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion ® , today announced it has received 510(k) clearance from the U.S. Renuvion ® and J-Plasma ® offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results.

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MARCH 29, 2023

a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. has raised over $20 million so far from investors such as Accel, University of California – Ratan Tata Fund, Omidyar Network, TrueScale capital and Chiratae Ventures.

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Legacy MEDSearch

AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Headquartered in Gainesville, Fla., Are you hiring?

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European Pharmaceutical Review

FEBRUARY 27, 2024

“As part of Amgen’s global biomanufacturing network, Amgen Ohio will play an important role in helping us address serious disease around the world with our innovative biomedicines.” ” Amgen Ohio is nearly 300,000 ft 2 in size and will employ 400 full-time staff.

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Legacy MEDSearch

JULY 14, 2023

Food and Drug Administration’s 510(K) clearance of AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation. This product reinforces AlloSource’s commitment to providing innovative products to support the overall sports medicine market, including hip arthroscopy. Learn more at allosource.org.

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SEPTEMBER 26, 2023

Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. . IDE study with 300 patients enrolled. Are you hiring?

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MAY 22, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The designation allows a collaborative and streamlined review pathway with FDA so the Orlucent technology can get to the market faster. Orlucent, Inc., president of Orlucent.

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OCTOBER 9, 2023

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States. Are you hiring?

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JULY 18, 2023

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). The ReddyPort elbow safely delivered 45,000 compliant oral care sessions to patients under FDA Emergency Use Authorization (EUA). Are you hiring?

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AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

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AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. The FDA clearance of BAROguard is a major step in providing transplant teams with leading technology to enhance organ transplantation outcomes.”

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OCTOBER 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. With this FDA 510(k) clearance, Pleural Dynamics will begin real-world clinical use of the ACES System with select hospitals and health systems. Are you hiring?

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