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.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

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

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

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. and projected to impact 70 million Americans by 2040.

Marketing 96

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.

FDA 52

FDA Food and Drug Administration Physicians 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.

Food and Drug Administration 52

Food and Drug Administration Recruitment Safety Medical 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.,

Food and Drug Administration 52

Food and Drug Administration FDA Medical Recruitment 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. Images seen in “straight-ahead” vision are magnified 2.7x

Food and Drug Administration 52

Food and Drug Administration Recruitment FDA Patients 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. Metabolic disorders have remained the leading therapy area for DCT adoption for over five years, mainly due to the use of wearables, such as glucometers, and other smart devices.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

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.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Food 52

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.

Pharmaceutical 127

Pharmaceutical Food and Drug Administration Manufacturing FDA 127

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.

Pharma 90

Pharma Recruitment Food and Drug Administration Patients 90

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

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52