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).

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Food and Drug Administration Patients Safety 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

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.

Food and Drug Administration 105

Food and Drug Administration Patients Networking Transportation 105

Pharmaceutical Technology

MAY 1, 2023

In February this year, the US Food and Drug Administration (FDA) accepted for filing the company’s new drug application (NDA) for Avacincaptad Pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Both the companies’ Boards of Directors have unanimously approved the deal.

Food and Drug Administration 111

Food and Drug Administration Pharma Food Networking 111

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.

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FDA Patients Food and Drug Administration Recruitment 52

Legacy MEDSearch

JUNE 9, 2023

Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). At present, patients with long blockages of the superficial femoral artery (SFA) have limited treatment options. million Americans are affected by PAD.

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FDA Patients Food and Drug Administration Recruitment 52

Pharmaceutical Technology

MAY 17, 2023

WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients. Last month, the therapy received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to treat hospitalised Covid-19 adult patients.

Manufacturing 52

Manufacturing Food and Drug Administration Networking FDA 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. Several non-clinical and clinical studies provide proof of concept for metronomic dosing, including improved patient outcomes. New hope for stomach cancer patients.

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Patients Food and Drug Administration Side effects Safety 82

Legacy MEDSearch

APRIL 7, 2023

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 metal resection guides sit noticeably better on the bone and offer greater saw control compared to the historically polymer patient-specific instruments.

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

Pharmaceutical Technology

MARCH 10, 2023

It represents one of the largest-ever global private-sector investments in the country and strengthens the company’s Europe-wide production network. Sandoz CEO Richard Saynor said: “Biosimilar medicines increase access to cutting-edge biologic therapies for the patients who need them most. “At

Food and Drug Administration 52

Food and Drug Administration Networking Medicine Food 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.

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Food and Drug Administration Medicine Medical Consulting 87

Legacy MEDSearch

NOVEMBER 1, 2022

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. The new 7.5mm device is designed to simplify surgery and to provide strong, stable, curved fixation in smaller patients. CurvaFix, Inc., every year. About CurvaFix, Inc. CurvaFix, Inc.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

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.

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FDA Food and Drug Administration Recruitment Networking 95

pharmaphorum

DECEMBER 22, 2022

In the case of rare diseases, patients get randomised into different arms, and what is needed if every patient is going into a trial is to actually generate some data: there has to be funding for this, Bingham said. Also, food for prevention. Patient engagement and prevention on a plate. Then, head-to-head studies.

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Food Patients Networking Distribution 86

European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. Cedars-Sinai’s Institutional Review Board (IRB) will monitor the studies for Alpha network sites. Scientific and operational teams.

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Food and Drug Administration Medicine Training Electronics 82

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

Legacy MEDSearch

MARCH 16, 2023

The DeltaScan Brain State Monitor provides a quick and objective measurement of acute brain failure even before symptoms appear, enabling clinicians to provide immediate treatment and help patients regain cognitive well-being. It’s clear from the evidence that minimizing the duration of acute brain failure can improve outcomes.”

FDA 52

FDA Food and Drug Administration Patients Recruitment 52

Pharmaceutical Technology

JULY 21, 2022

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Additionally, AI can improve patient wellbeing by automating health records, predicting illness, and enhancing treatment efficiency. Staff must be trained on processes and systems and patients made aware of security best practices.

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Food and Drug Administration Government Pharma Healthcare 98

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment Medical 98

Legacy MEDSearch

MARCH 1, 2024

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.” of balloon angioplasty patients and 17.9% of AGENT DCB patients.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Clarivate

APRIL 24, 2023

Health systems will buy or establish an insurance plan to serve as an extension of their continuum of care, a means of directing referral streams to increase revenue and securing control over clinical and formulary decisions for patients.

Healthcare 89

Healthcare Healthcare Marketing Physicians 89

European Pharmaceutical Review

FEBRUARY 15, 2023

Final analyses of a Phase II trial for resectable non-small cell lung cancer (NSCLC) has concluded that 60 percent of patients treated with neoadjuvant nivolumab remained recurrence-free five years after surgery. In the trial, 20 stage I-III resectable NSCLC patients were treated with two doses of neoadjuvant nivolumab.

Food and Drug Administration 85

Food and Drug Administration Patients Food Networking 85

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

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

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

Safety 59

Safety Food and Drug Administration FDA Side effects 59

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

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. The clearance was based on clinical data from the Company’s IDE approved study for the treatment of sebaceous hyperplasia.

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FDA Food and Drug Administration Recruitment Medicine 98

European Pharmaceutical Review

JULY 17, 2023

billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 This was ~10 percent of reported industry spending.

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Food and Drug Administration Training Pharmaceutical Food 82

Legacy MEDSearch

JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc., Axonics recently ranked No.

FDA 98

FDA Food and Drug Administration Recruitment Medical 98

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. FemDx Medsystems, Inc.,

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. Our goal is to bring this new therapy to patients as quickly as possible. We look forward to working closely with the FDA to expedite the review of the EndoStim System.”. About the EndoStim System. About EndoStim.

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Food and Drug Administration FDA Side effects Recruitment 98

European Pharmaceutical Review

JANUARY 19, 2023

The contribution will enable the programme to reach additional physicians and medical students, further expanding the initiative that aims to extend the reach of clinical trials in underserved patient populations in US communities. The Winn Award Program has so far trained 114 early-stage investigator physicians.

Food and Drug Administration 79

Food and Drug Administration Physicians Medicine Food 79

Legacy MEDSearch

JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung Expansion (OLE) therapy. We are proud to introduce this innovative OLE therapy system.”

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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. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Food and Drug Administration Recruitment Medical Food 98

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 76

Food and Drug Administration Manufacturing Safety Transportation 76

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. Our clients include both blue-chip companies and innovative startups within the MedTech space.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Clarivate

SEPTEMBER 26, 2023

One of the critical factors determining the success of a clinical trial is the selection of appropriate clinical sites that have evidenced access to specific patient populations. Patient recruitment accounts for 32% of all trial costs and patient drop out averages 18%, according to Deloitte figures. Food and Drug Administration.

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Food and Drug Administration Electronics Patients Healthcare 59