Legacy MEDSearch

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. The approval provides patients implanted with the Evoke ® System the ability to undergo 1.5

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Legacy MEDSearch

MARCH 21, 2023

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc.,

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Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.

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Food and Drug Administration Recruitment Medical Food 98

World of DTC Marketing

FEBRUARY 4, 2021

Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. I am reminded of a business colleague who left a company in the midwest after being recruited heavily by Amgen. prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4

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Pharma Food and Drug Administration Side effects Safety 180

Legacy MEDSearch

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 Co.,

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Medical Food and Drug Administration FDA Recruitment 52

Legacy MEDSearch

JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “This submission is another milestone in KORU Medical’s mission to make subcutaneous therapy radically simpler and easier for patients. . The post KORU Medical Systems, Inc.

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Medical Food and Drug Administration Recruitment Manufacturing 40

PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

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Pharma Food and Drug Administration Government Medicine 105

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. This system fills that void for both surgeons and patients.” I’m excited that the study met its superiority composite endpoint, which included effectiveness and safety components.

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Marketing FDA Food and Drug Administration Specialization 96

Legacy MEDSearch

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. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.

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FDA Food and Drug Administration Physicians Safety 52

Legacy MEDSearch

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., About CereVasc, Inc. Press Release by: CereVasc.

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FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

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 Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.

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FDA Food and Drug Administration Physicians Recruitment 52

Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Ancora Heart , Inc., An estimated 6.5 million U.S. An estimated 6.5

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Food and Drug Administration FDA Medical Recruitment 52

Legacy MEDSearch

JUNE 16, 2023

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

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Food and Drug Administration Recruitment Safety Medical 52

Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care. appeared first on Legacy MedSearch | Medical Device Recruiters. Itatani, MD, Ph.D.,

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FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

JULY 11, 2022

Samsara Vision , a company focused on bringing vision and freedom back to patients with late-stage, age-related macular degeneration (AMD) through advanced visual prosthetic devices, announced the completion of the first U.S. It is implanted during typical, out-patient cataract surgery with a corneal incision range between 6.5

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Food and Drug Administration Recruitment FDA Patients 52

Legacy MEDSearch

MAY 23, 2022

Surgeons are tethered to the surgical tower by a power cable and by a light cord that is often implicated in OR fires and patient burns. The expected benefits include ease of use, improved OR efficiency, reduction in costs, and better patient outcomes. But we are at the dawn of a new era. Press Release by: Lazurite .

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Food and Drug Administration Medicine Recruitment Physicians 52

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. However, there is still some use of remote patient monitoring technologies.

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Food and Drug Administration Electronics Healthcare Healthcare 52

European Pharmaceutical Review

JUNE 29, 2023

The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Phase II clinical trials in the US and China are now underway for INS018_055, Insilico Medicine’s potentially first-in-class oral drug candidate. Patients will be divided into four parallel cohorts.

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Food and Drug Administration Safety Recruitment FDA 93

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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Legacy MEDSearch

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.

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Medical FDA Food and Drug Administration Recruitment 98

Pharmaceutical Technology

FEBRUARY 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The dual FLT-3 and Aurora kinase inhibitor EP0042 is being developed to treat AML patients who have developed FLT3 inhibitor resistance.

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Food and Drug Administration FDA Recruitment Food 52

Legacy MEDSearch

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 FDA cleared SCINTIX biology-guided radiotherapy to treat patients with lung and bone tumors.

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FDA Food and Drug Administration Recruitment Medical 97

Pharmaceutical Technology

APRIL 25, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1044 to treat people with Duchenne muscular dystrophy (DMD) mutations amenable to exon 44 skipping (DMD44). The company intends to reveal data from the trial’s healthy volunteer portion in the second half of 2023.

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Food and Drug Administration FDA Recruitment Food 52

Legacy MEDSearch

SEPTEMBER 29, 2023

Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. When conservative care fails, these patients have limited treatment options. ReGelTec, Inc. announced that the U.S. Vapotherm (NYSE:VAPO), and National Sleep Technologies.

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FDA Food and Drug Administration Recruitment Medical 52

Impetus Digital

NOVEMBER 14, 2022

We know from real-world evidence that drug efficacy and safety can differ based on age, sex, race, and ethnicity; these discrepancies may jeopardize treatment outcomes in undertested groups. Many clinical trials are struggling to recruit diverse participants, particularly from rural or remote areas far from large academic hospitals.

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Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. But are they doing enough to make a significant impact and accurately reflect the diverse patient population? Current FDA guidance. In April 2022, the U.S.

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Pharma Food and Drug Administration Medicine Patients 40

Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. But are they doing enough to make a significant impact and accurately reflect the diverse patient population? Current FDA guidance In April 2022, the U.S.

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Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

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Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations. Leveraging real-world data to develop the clinical trials diversity plan.

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FDA Food and Drug Administration Recruitment Transportation 52

Legacy MEDSearch

SEPTEMBER 11, 2023

Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement.

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