Legacy MEDSearch

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.”

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

World of DTC Marketing

JANUARY 10, 2022

It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 5 drugs) ranged from $765.9

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Food and Drug Administration Pharma Marketing Food 213

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

Legacy MEDSearch

DECEMBER 7, 2022

Medical device and technology company Lazurite has received recognition from Medical Device Network Excellence Awards & Rankings, one of the largest, most prestigious, and widely recognized programs in the industry. All Commended companies will be entered into the Medical Device Network Awards at the end of the year.

Networking 98

Networking Medical Food and Drug Administration Recruitment 98

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

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

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

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.” US sales of Stelara totalled $6.4

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Food and Drug Administration FDA Side effects Safety 85

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

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

Pharmaceutical Technology

MARCH 14, 2023

The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval. The new investigational treatment CTx-1301 is being developed as a once-daily stimulant medication for the treatment of ADHD.

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Food and Drug Administration Medical FDA Marketing 59

Pharmaceutical Technology

JUNE 19, 2023

It has also been approved for the treatment of moderate to severe PsA in patients aged six years or above and adult patients with moderate to severe active Crohn’s disease. The company stated that the collaboration will use the local presence, sales and marketing capabilities of Biomm in Brazil.

Food and Drug Administration 52

Food and Drug Administration Distribution Food Marketing 52

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

European Pharmaceutical Review

JANUARY 24, 2023

HUTCHMED will receive $400 million upfront as well as up to $730 million on meeting regulatory, development and commercial sales milestones. This is in addition to royalties on net sales. FRESCO-2 showed clinically meaningful improvement in overall survival in patients with metastatic CRC and was generally well tolerated.

Food and Drug Administration 52

Food and Drug Administration Biopharma Medical Sales 52

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

Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.

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Food and Drug Administration Physicians Prescription Medical 111

Pharmaceutical Technology

JANUARY 23, 2023

The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. We look forward to utilising our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China. “We

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Food 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

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. Press Release by: IRRAS.

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FDA Food and Drug Administration Recruitment Networking 95

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

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

Pharma Leaders

MAY 15, 2023

Filed in the US Bankruptcy Court for the Southern District of Texas, the proceedings will allow the company to pursue expedited sales process. Biopharmaceutical company Athenex and some of its subsidiaries voluntarily have filed Chapter 11 proceedings of the US Bankruptcy Code.

Food and Drug Administration 52

Food and Drug Administration Sales process Food Sales 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

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

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

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

Pharmaceutical Technology

JANUARY 31, 2023

As per the terms of the agreement, Daewoong will receive a total consideration of up to $336m, including upfront and development milestone payments of up to $76m, along with royalties on net sales. The Korea Drug Development Fund is supporting the trial by providing funds.

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Food and Drug Administration Food Pharmaceutical Medicine 52

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

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.

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FDA Food and Drug Administration Recruitment Medicine 98

Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. De-risking drug launch. This figure represents a 2.4% Insourcing vs outsourcing.

Food and Drug Administration 52

Food and Drug Administration Pharma Medicine Distribution 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.

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FDA Food and Drug Administration Recruitment Management 95

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.

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FDA Food and Drug Administration Recruitment Medical 95

Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. For more information, please visit: www.NeuroLogica.com. Press Release by: NeuroLogica.

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FDA Food and Drug Administration Electronics Recruitment 92