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

FDA 98

FDA Food and Drug Administration Recruitment Medicine 98

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.

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Food 98

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.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

Legacy MEDSearch

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., Carl Heilman, M.D., and Adel Malek, M.D.,

Food and Drug Administration 52

Food and Drug Administration FDA Patients Recruitment 52

Legacy MEDSearch

JULY 21, 2023

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. Aurélien Beaugerie and Dr. Christophe Vaessen.

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). For additional important safety information, please see the CHG Instructions For Use. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM Infusion System as compared to vials. The post KORU Medical Systems, Inc.

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Medical Food and Drug Administration Recruitment Manufacturing 40

Legacy MEDSearch

MARCH 2, 2023

Food and Drug Administration (“FDA”) for the use of the Renuvion APR Handpiece “for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. “We Our clients include both blue-chip companies and innovative startups within the MedTech space.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

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.

FDA 52

FDA Food and Drug Administration Physicians Safety 52

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%

Pharma 105

Pharma Food and Drug Administration Government Medicine 105

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., Press Release by: CereVasc.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

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. 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

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

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. appeared first on Legacy MedSearch | Medical Device Recruiters.

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FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. Food and Drug Administration. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Ancora Heart , Inc.,

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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

JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Press Release by: Samsara Vision.

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Food and Drug Administration Recruitment FDA Patients 52

Legacy MEDSearch

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. 2015) designs devices to set new operating-room standards for efficiency and patient safety.

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Food and Drug Administration Medicine Recruitment Physicians 52

Pharmaceutical Technology

APRIL 13, 2023

Lower DCT usage for Phase I studies may be accounted for due to the heavier focus on safety and efficacy, and increased monitoring of trial participants in-person. In the US, the FDA (Food and Drug Administration) granted accelerated approvals of medical devices with AI in 2022 [8] , and growing use is expected throughout 2023.

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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 95

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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Food and Drug Administration Prescription Media FDA 88

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.

Medical 98

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). This will enable the addition of US trial sites, as well as the recruitment of eligible patients in the country to the trial.

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Food and Drug Administration FDA Recruitment Food 52

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. ReGelTec, Inc. announced that the U.S. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process.

FDA 52

FDA Food and Drug Administration Recruitment Medical 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. RefleXion Medical , a therapeutic oncology company, announced the U.S.

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FDA Food and Drug Administration Recruitment Medical 97

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

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Pharmaceutical Food and Drug Administration Manufacturing FDA 128

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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Pharma Recruitment Food and Drug Administration Patients 98

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. Patient-centric approach: Seeking patient input throughout drug development processes can be critical to the success of pharma. Current FDA guidance.

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Pharma Food and Drug Administration Medicine FDA 40

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.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

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.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

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. Patient-centric approach: Seeking patient input throughout drug development processes can be critical to the success of pharma.

Pharma 40

Pharma Food and Drug Administration Patients Medicine 40

Legacy MEDSearch

SEPTEMBER 11, 2023

Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. ” About Zeta Surgical Zeta Surgical is a digital surgery company focused on improving the accuracy, safety, and accessibility of image guided procedures.

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FDA Food and Drug Administration Recruitment Medical 52