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. The Cedars-Sinai Board of Governors Regenerative Medicine Institute and the Smidt Heart Institute will lead the project. Scientific and operational teams.

Food and Drug Administration 79

Food and Drug Administration Medicine Training Electronics 79

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.

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Food and Drug Administration FDA Recruitment Food 98

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.

Patients 79

Patients Food and Drug Administration Side effects Safety 79

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. This delay often leads to cognitive impairment, worse health outcomes, and increased costs,” said Dr. .

FDA 52

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Legacy MEDSearch

MARCH 15, 2023

In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

Food and Drug Administration 97

Food and Drug Administration FDA Recruitment Physicians 97

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

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.

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Food and Drug Administration Safety Recruitment Medical 98

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.

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Food and Drug Administration Patients Food Networking 82

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

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

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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. The EndoStim System consists of an implantable neurostimulation device and lead placed via a quick, minimally-invasive laparoscopic procedure.

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Food and Drug Administration FDA Side effects Recruitment 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. The post Why Is FDA Issuing Fewer Marketing Violation Letters?

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NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite. For more information, please visit: www.NeuroLogica.com.

FDA 92

FDA Food and Drug Administration Electronics Recruitment 92

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

Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.

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FDA Food and Drug Administration Recruitment Medical 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.

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AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. The FDA clearance of BAROguard is a major step in providing transplant teams with leading technology to enhance organ transplantation outcomes.”

FDA 52

FDA Food and Drug Administration Transportation Recruitment 52

Legacy MEDSearch

JULY 18, 2023

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). 1 The ReddyPort elbow also enables patients and clinicians to use the ReddyPort microphone.

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FDA Food and Drug Administration Recruitment Patients 52

Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. We are committed to continuous improvement to optimize the clinical utility of the Swoop® system while driving commercial adoption across leading institutions globally. Hyperfine, Inc., About Hyperfine, Inc.

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Food and Drug Administration FDA Recruitment 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 73

Food and Drug Administration Manufacturing Safety Transportation 73

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. Otsuka Medical Devices Co.,

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

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APRIL 27, 2023

(Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced that it received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA).

FDA 52

FDA Food and Drug Administration Recruitment Medical 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. This system fills that void for both surgeons and patients.” For these patients, total knee replacement is a reluctant option, as it is an end-stage treatment for end-stage disease.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

Legacy MEDSearch

JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. IntelliSep will be available in the United States in the coming weeks.

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Food and Drug Administration FDA Recruitment Physicians 98

European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Blockchain technology creates a decentralised and unalterable ledger that records all transactions across a network of computers.

Government 83

Government Pharma Ethics Training 83

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AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. It is the next generation of highly crosslinked polyethylene with vitamin E antioxidant that is intended to further our primary goal of providing immense benefits to our patients.” customers.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

Legacy MEDSearch

JULY 10, 2023

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

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. This approval marks a major milestone in the fight against Alzheimer’s, which is the sixth leading cause of death in the United States and affects over 5 million people.

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Food and Drug Administration FDA Consulting Food 52

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 Techsomed Ltd., VisAble.IO “We are excited to receive 510(k) clearance for our VisAble.IO The BioTrace.IO

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52

Legacy MEDSearch

AUGUST 10, 2023

The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure. The designation is a testament to Acorai’s commitment to driving innovation in patient care.

Food and Drug Administration 52

Food and Drug Administration Management Recruitment Medical 52

Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). Paradigm utilizes an advanced approach to replace traditional surgical navigation technologies that pull attention away from the patient and disrupt workflows in the process. ABOUT PROPRIO Proprio is a leading medical technology company creating the new way of seeing in surgery.

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

JUNE 16, 2023

Food and Drug Administration. The study permits surgeons to select the investigational device—the pro disc C Vivo and/or pro disc C SK —based on the patient’s anatomy, as well as other surgical factors. This study will help advance and improve cervical disc replacement surgery for the benefit of our patients.”

Food and Drug Administration 52

Food and Drug Administration Recruitment Safety Medical 52

Pharmaceutical Technology

JUNE 29, 2022

For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. Continuing advancements within this field deliver new hope to doctors and patients, transforming disease outcomes for previously incurable indications.

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Specialization Biopharma B2B Sales Manufacturing 118

European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Going forward, it is imperative for companies to invest in constructing more resilient supply networks.

Pharmaceutical 91

Pharmaceutical Food and Drug Administration Transportation Manufacturing 91

Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). The InTandem name reflects both the synchronization inherent in the device’s mechanism of action and the partnership formed between patient and device. The burden on patient functioning is also profound. MedRhythms also unveiled the brand name for MR-001: InTandem.

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Ancora Heart , Inc., An estimated 6.5 million U.S. An estimated 6.5 million U.S.

Food and Drug Administration 52

Food and Drug Administration FDA Medical Recruitment 52

Legacy MEDSearch

JANUARY 11, 2023

Micronoma , the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, announced that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA). Early detection of lung cancer can lead to a higher survival rate. In the U.S.,

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FDA Food and Drug Administration Recruitment Patients 52