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. See Full Press Release at the Source: POLARIS AR RECEIVES CLEARANCE FROM THE U.S.

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Food and Drug Administration Food Recruitment Medical 52

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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). CurvaFix, Inc., The company is focusing on Fragility Fractures of the Pelvis and high-impact pelvic fractures.

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Food and Drug Administration FDA Recruitment Food 98

European Pharmaceutical Review

JULY 17, 2023

billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. million publications describing basic or applied research related to 386 of 387 drugs approved 2010-2019 with $8.1 million per approved drug. billion (3.3 Average NIH spending was $33.8

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Food and Drug Administration Training Pharmaceutical Food 98

Pharmaceutical Technology

JUNE 5, 2023

The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023. The company’s commercial strategy for the therapy includes an extensive patient support programme named RYZUP, which supports and educates those for whom the drug is prescribed and assists with access to the medicine.

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Food and Drug Administration Pharmaceutical Specialization Food 98

Pharmaceutical Technology

MAY 1, 2023

In February this year, the US Food and Drug Administration (FDA) accepted for filing the company’s new drug application (NDA) for Avacincaptad Pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

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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. These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm and 5.0mm treatment tip sizes.

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FDA Food and Drug Administration Recruitment Medicine 98

Legacy MEDSearch

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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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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DECEMBER 8, 2022

Food and Drug Administration (FDA). “FDA clearance is a significant milestone towards the commercialization of Polso CONNECT and towards creating a new model in chronic care management,” said ChroniSense Medical CEO, Bridget Ross. “FDA clearance is an important validation of our technology.

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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.

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Food and Drug Administration FDA Recruitment Medical 98

European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Another benefit is that fewer patients are required in clinical trials using HCs, thereby reducing time to trial completion and speeding drug approval. Patel et al.

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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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FDA Food and Drug Administration Recruitment Management 95

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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Manufacturing Food and Drug Administration Food Networking 105

Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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Safety Food and Drug Administration FDA Side effects 59

Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Tyber Medical is committed to providing rapid access to FDA-cleared and CE-marked private label, orthopedic device technology that advance patient care and healing outcomes. About Tyber Medical LLC.

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JANUARY 3, 2023

Food and Drug Administration for its Respiratory Health point of care test. See Full Press Release at the Source: Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for use in CLIA waived settings. About Visby Medical. For more information, visit www.visby.com. Are you hiring?

Medical 98

Medical Food and Drug Administration FDA Recruitment 98

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JANUARY 19, 2023

Food and Drug Administration (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.

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JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The post Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System appeared first on Legacy MedSearch | Medical Device Recruiters. Axonics, Inc., Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 98

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JANUARY 10, 2023

a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. . Food and Drug Administration (FDA). VERO Biotech Inc., VERO Biotech Inc. Are you hiring?

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FDA Food and Drug Administration Recruitment Management 98

Pharmaceutical Technology

NOVEMBER 7, 2022

The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

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Food and Drug Administration Food Networking Safety 98

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NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. 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. About NeuroLogica. NeuroLogica Corp., Are you hiring?

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MARCH 13, 2023

Food and Drug Administration (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. and Europe. Are you hiring?

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Medical FDA Food and Drug Administration Recruitment 98

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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.

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Manufacturing FDA Food and Drug Administration Medical 98

European Pharmaceutical Review

MAY 22, 2024

WHO confirmed that the newly approved WLAs include: The European Medicines Regulatory Network (EMRN), which is made up of the European Commission (EC), the European Medicines Agency (EMA) and the medicines regulatory authorities of 30 countries.

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Medicine Leads Food and Drug Administration Safety 93

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JUNE 7, 2022

Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. Announces FDA Clearance for FreedomFlow® Peripheral Guidewire, plus First Commercial Case Completed in U.S. Cardio Flow, Inc., For further information, visit www.acvcenters.com. Press Release by: Cardio Flow, Inc.

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Food and Drug Administration FDA Recruitment Medical 98

European Pharmaceutical Review

AUGUST 1, 2022

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. The US Food and Drug Administration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations. .

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Food and Drug Administration Medical Medicine Engineering 122

Pharmaceutical Technology

JULY 21, 2022

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. 3D printing.

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Food and Drug Administration Government Pharma Healthcare 98

European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. Cedars-Sinai’s Institutional Review Board (IRB) will monitor the studies for Alpha network sites. Scientific and operational teams.

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Food and Drug Administration Medicine Training Electronics 98

Legacy MEDSearch

DECEMBER 1, 2022

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. The FDA clearance of the QStat Cartridge expands the Quantra System’s indications for use to include trauma, and liver transplantation procedures. market today. Press Release by: HemoSonics, LLC. Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 95

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SEPTEMBER 12, 2022

Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. See Full Press Release at the Source: Aerin Medical Receives FDA Clearance of Next-Generation RhinAer® Stylus for Treatment of Patients with Chronic Rhinitis. Aerin Medical Inc., Press Release by: Aerin Medical.

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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., ” About Okami Medical, Inc.

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Medical FDA Food and Drug Administration Recruitment 90

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APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Also, we recognize the dedicated reviewers at FDA for completing their thorough benefit-risk assessment of our breakthrough technology. Are you hiring?

Marketing 96

Marketing FDA Food and Drug Administration Recruitment 96

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FEBRUARY 3, 2023

Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers. The X1 also has a state-of-the-art anatomic modality previously cleared by the FDA for solid tumors located anywhere in the body.

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FDA Food and Drug Administration Medical Recruitment 97

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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. Are you hiring? Contact us to discuss partnering with Legacy MedSearch on your position.

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Food and Drug Administration FDA Recruitment Medical 98

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MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. The post FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor appeared first on Legacy MEDSearch. On March 5, the U.S.

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MARCH 1, 2024

Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (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?

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DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The device previously received the FDA’s Breakthrough Designation for its potential to provide significant advantages over currently approved spinal stabilization technologies. Empirical Spine, Inc.,

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