Legacy MEDSearch

NOVEMBER 3, 2023

Food and Drug Administration (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.

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Food and Drug Administration Food Recruitment Medical 52

Pharma Leaders

JUNE 28, 2023

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).

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Food and Drug Administration FDA Safety Food 52

Legacy MEDSearch

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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Food and Drug Administration FDA Recruitment Marketing 52

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.

Marketing 52

Marketing FDA Food and Drug Administration Recruitment 52

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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Marketing Pharma Food and Drug Administration Media 52

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.

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FDA Food and Drug Administration Electronics Recruitment 92

World of DTC Marketing

FEBRUARY 2, 2022

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and Drug Administration on Biogen Inc.’s Top researchers who advised the U.S.

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Food and Drug Administration Physicians Side effects Doctors 239

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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FDA Food and Drug Administration Recruitment Networking 95

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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FDA Food and Drug Administration Recruitment Food 52

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology.

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Legacy MEDSearch

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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FDA Food and Drug Administration Recruitment Medicine 98

Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. The company stated that azithromycin tablets generated annual sales of $20m in the US.

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Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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Food and Drug Administration FDA Food Safety 52

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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Food and Drug Administration FDA Recruitment Food 98

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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FDA Food and Drug Administration Recruitment Medical 98

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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Food and Drug Administration FDA Recruitment Side effects 98

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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FDA Food and Drug Administration Recruitment Medical 52

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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Food and Drug Administration FDA Recruitment Physicians 52

Evolve Your Success

OCTOBER 24, 2023

OEM Sales is about creating solutions to win customers and making an impact, one deal at a time. In this episode, we have Sean Pitts from GCX corporation to uncover the ins and outs of OEM Sales. Sean discusses the critical qualities that make an exceptional OEM sales representative. If y ou ask, “W hat is OEM sales ?”

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Sales Medical Manufacturing Medical sales 64

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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Food and Drug Administration FDA Recruitment Physicians 52

Legacy MEDSearch

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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Legacy MEDSearch

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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FDA Food and Drug Administration Recruitment Medical 95

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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Marketing Pharma Food and Drug Administration Media 40

Pharmaceutical Technology

JULY 28, 2022

The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The frequency of administration associated with a therapy is a critical factor that companies in this space focus on to fine-tune their chances of success in the wAMD market.

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Marketing Food and Drug Administration FDA Doctors 52

Legacy MEDSearch

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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FDA Food and Drug Administration Recruitment Medical 52

World of DTC Marketing

SEPTEMBER 7, 2022

They relied so much on a new drug that they tried to market a product with bad science behind it. Rather than investing more in R&D, most pharma companies feel its more cost-effective to buy small biotech companies developing unique molecules that can find a market niche. oncology therapeutics market has reached $71 billion.

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Pharma Food and Drug Administration Marketing Prescription 210

Legacy MEDSearch

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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Food and Drug Administration FDA Recruitment Food 52

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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Medical FDA Food and Drug Administration Recruitment 52

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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Food and Drug Administration FDA Recruitment Food 98

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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Food and Drug Administration FDA Distribution Recruitment 52

World of DTC Marketing

JANUARY 10, 2022

A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 This study included 63 of 355 new therapeutic drugs and biologic agents approved by the US Food and Drug Administration between 2009 and 2018. million (95% CI, $683.6 million $1228.9

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pharmaphorum

AUGUST 11, 2022

GSK, its consumer health spin-off Haleon and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug pulled from the market in 2020 after it was linked to cases of cancer. Some voluntarily took their products off the market as soon as the NDMA finding was reported by the FDA.

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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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FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

JUNE 6, 2023

Lotus will purchase global rights for NRX-101 and handle the commercialisation activities of the product in markets outside the US. The company will receive a further $5m on gaining US FDA approval for NRX-101, and $330m milestone payments on reaching net sales targets.

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Legacy MEDSearch

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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FDA Food and Drug Administration Recruitment Patients 52

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.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

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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Food and Drug Administration FDA Recruitment Marketing 52