Legacy MEDSearch

SEPTEMBER 26, 2023

Saluda Medical, Inc. (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced that the U.S. IDE study with 300 patients enrolled. head and extremity and 1.5T

Medical 52

Medical FDA Food and Drug Administration Safety 52

Pharmaceutical Technology

MAY 1, 2023

Iveric Bio is focused on the discovery as well as development of new therapies for retinal diseases with significant unmet medical needs. We believe that this acquisition will enable us to deliver greater VALUE to patients with ocular diseases at high risk of blindness.”

Food and Drug Administration 111

Food and Drug Administration Pharma Food Networking 111

Legacy MEDSearch

NOVEMBER 2, 2023

Xēnix Medical, a surgical implant company focused on the development of novel science-based solutions for patients requiring spinal fusion surgery, today announced that it has received 510(k) clearance from the U.S.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

European Pharmaceutical Review

FEBRUARY 8, 2024

Regulatory plans for the cystic fibrosis medicine By mid-2024, Vertex declared that it plans to submit a New Drug Application (NDA) to the US Food and Drug Administration and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in patients with cystic fibrosis aged six years and older.

Food and Drug Administration 86

Food and Drug Administration Medicine Medical Consulting 86

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. “We are pleased to bring technologies to the U.S.

Food and Drug Administration 52

Food and Drug Administration FDA Distribution Recruitment 52

PM360

FEBRUARY 12, 2024

Created by The European Organization for Rare Diseases (EURORDIS) , this globally coordinated event brings together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers, and their families. Since rates in children are generally low, every pediatric cancer is deemed rare.

Food and Drug Administration 105

Food and Drug Administration Patients Networking Medical 105

Legacy MEDSearch

NOVEMBER 1, 2022

a developer of medical devices to repair fractures in curved bones, announced it has received 510(k) clearance (K222505) from the U.S. Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. CurvaFix, Inc., every year.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

Legacy MEDSearch

JULY 10, 2023

KORU Medical Systems, Inc. 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.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

Legacy MEDSearch

SEPTEMBER 18, 2023

a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that the U.S. to improve the usability of the system without compromising functionality or patient safety and are looking forward to its use in the study,” he continued. . CereVasc, Inc., Carl Heilman, M.D.,

Food and Drug Administration 52

Food and Drug Administration FDA Patients Recruitment 52

Pharmaceutical Technology

JULY 21, 2022

Pharma and medical device companies are implementing AI to transform supply chains and better manage their operations. AI also speeds up the drug development process, which could translate into cheaper drugs for patients. 3D bioprinting offers an alternative to animal testing in drug development. 3D printing.

Food and Drug Administration 98

Food and Drug Administration Government Pharma Healthcare 98

Pharmaceutical Technology

MAY 16, 2023

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

Pharmaceutical 52

Pharmaceutical Food and Drug Administration Pharmaceutical manufacturing Manufacturing 52

Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. The drug works by blocking an enzyme known as BACE1, which is responsible for producing beta-amyloid.

Food and Drug Administration 52

Food and Drug Administration FDA Consulting Food 52

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects.

Patients 81

Patients Food and Drug Administration Side effects Safety 81

Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration).

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

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. ” About IRRAS. For more information, please visit www.irras.com.

FDA 95

FDA Food and Drug Administration Recruitment Networking 95

Legacy MEDSearch

JUNE 9, 2023

Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD).

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

Legacy MEDSearch

NOVEMBER 14, 2022

Food and Drug Administration (FDA). IntraOpVSP displays patient CT and MRI as three-dimensional holograms in AR headsets, helping surgeons visualize surgical plans, anatomical targets, and cutting guides alongside or overlayed on the patient. Food and Drug Administration cleared the software for use in 2022.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Food 52

Legacy MEDSearch

OCTOBER 17, 2023

FloBio , a medical diagnostics company, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. DOACs can elevate bleeding risk and complicate emergency care.

Food and Drug Administration 52

Food and Drug Administration Recruitment FDA Management 52

Legacy MEDSearch

APRIL 7, 2023

restor3d, a research-driven medical device company, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR is entering an initial release in April with full availability in June 2023.

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

Legacy MEDSearch

MAY 18, 2023

Food and Drug Administration has granted the Connexus DDI “Breakthrough Device Designation”, which offers an expedited review process for transformative medical devices with the potential to treat irreversibly debilitating conditions. In addition to the funding, Paradromics announced that the U.S.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

European Pharmaceutical Review

AUGUST 1, 2022

The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said. The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team.

Food and Drug Administration 106

Food and Drug Administration Medical Medicine Engineering 106

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

Food and Drug Administration 52

Food and Drug Administration Side effects Recruitment Safety 52

Legacy MEDSearch

SEPTEMBER 6, 2022

Magnus Medical, Inc. , a medical device company and developer of brain stimulation technology for treatment of neuropsychiatric disorders, announced it received 510(k) clearance from the U.S. Schatzberg, M.D. , the Kenneth T. Norris, Jr. George, M.D., This is more than just clearance of another device.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

MARCH 27, 2023

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. The LCD screen on the handle of the device allows the physician to visualize internal patient anatomy in line with instrument insertion. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Legacy MEDSearch

DECEMBER 6, 2022

The CE Mark validates that ActivSight meets the requirements of the European Medical Devices Regulation, allowing Activ Surgical to commercialize the enhanced imaging system across the European Union and other CE Mark required regions. To date, multiple major hospital networks across the U.S. About Activ Surgical.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment Medical 98

Legacy MEDSearch

OCTOBER 24, 2023

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. “Our unique stenting technology is designed to simplify procedures, improve patient outcomes, and reduce angioplasty times, marking a significant advancement in coronary treatments.”

FDA 52

FDA Food and Drug Administration Recruitment Food 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.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

Legacy MEDSearch

SEPTEMBER 12, 2023

Food and Drug Administration (FDA) has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation. At LimFlow, our vision is to achieve great outcomes for patients suffering from CLTI.

FDA 52

FDA Patients Food and Drug Administration Recruitment 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.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

Legacy MEDSearch

JANUARY 31, 2023

a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. Axonics, Inc., 1 ranking in 2021.

FDA 98

FDA Food and Drug Administration Recruitment Medical 98

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. appeared first on Pharma Marketing Network.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

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. 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

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.,

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Medical 52

Legacy MEDSearch

JANUARY 4, 2023

ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. ” About ABM Respiratory Care.

FDA 95

FDA Food and Drug Administration Recruitment Management 95

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

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.

FDA 95

FDA Food and Drug Administration Recruitment Medical 95

Legacy MEDSearch

OCTOBER 19, 2023

Pleural Dynamics, a medical device company that is building solutions for chronic, recurrent fluid collections in the body, today announced that the Company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. Added Kevin Henseler, M.D.,

FDA 52

FDA Food and Drug Administration Recruitment Medical 52