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.,

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Food and Drug Administration FDA Recruitment Food 98

Legacy MEDSearch

NOVEMBER 15, 2022

Tyber Medical LLC, the global, leading private-label medical device provider for major orthopedic trauma, extremity, and spine companies, has been awarded a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Press Release by: Tyber Medical.

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Medical FDA Food and Drug Administration Engineering 98

Legacy MEDSearch

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.

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FDA Food and Drug Administration Electronics Recruitment 92

Legacy MEDSearch

MARCH 15, 2023

Utilizing the Halo cloud-based platform allowed HeartBeam to meet its schedule for FDA submission of the HeartBeam AIMI software for acute care settings that provides a 3D vector electrogram (VECG) comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack.

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Food and Drug Administration FDA Recruitment Physicians 97

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.,

FDA 98

FDA Food and Drug Administration Recruitment Medical 98

Legacy MEDSearch

DECEMBER 8, 2022

Food and Drug Administration (FDA). ChroniSense Medical, a portfolio company of Rainbow Medical, is continuing its clinical development in collaboration with leading hospitals, partners, and expert practitioners in the U.S., ChroniSense Medical Ltd. and globally. Press Release by: ChroniSense Medical Ltd.

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FDA Patients Food and Drug Administration Medical 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.

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FDA Food and Drug Administration Recruitment Medical 95

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. For more information, please visit www.vivasuremedical.com.

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Medical FDA Food and Drug Administration Recruitment 98

Legacy MEDSearch

DECEMBER 21, 2022

Food and Drug Administration (FDA) for 510(k) clearance. The ALICE device is being contract manufactured by an end-to-end solution provider that offers New Product Introduction (NPI) services to mass production capabilities for leading medical electronic device companies. and Israel.

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Manufacturing FDA Food and Drug Administration Medical 98

Legacy MEDSearch

DECEMBER 6, 2022

Activ Surgical is on the leading edge when it comes to enhancing surgical vision and significantly reducing unintended medical errors, and I am confident that ActivSight will improve surgical outcomes.”. Activ Surgical received 501(k)-clearance for ActivSight by the Food and Drug Administration (FDA) in the United States in 2021.

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Food and Drug Administration Safety Recruitment Medical 98

Legacy MEDSearch

JANUARY 12, 2023

Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel Absorbable Surgical Hemostat. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Medcura, Inc., Press Release by: Medcura.

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Food and Drug Administration FDA Recruitment Medical 97

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. For updates, follow Cytovale on LinkedIn and Twitter. Press Release by: Cytovale.

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Food and Drug Administration FDA Recruitment Medical 98

Pharmaceutical Technology

APRIL 19, 2023

While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.

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Food and Drug Administration Recruitment Prospecting Food 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%

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Pharma Food and Drug Administration Medicine Government 105

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

European Pharmaceutical Review

MARCH 2, 2023

However, a good many companies are not yet well set up for this” In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022. Improvements were also seen in the drug development process itself.

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Food and Drug Administration Government Management Medicine 98

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. Knee OA develops when the joint’s natural shock absorbers, cartilage and meniscus, no longer cushion the joint from daily activities, leading to chronic pain and activity limitation.

Marketing 96

Marketing FDA Food and Drug Administration Recruitment 96

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

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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.

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Food and Drug Administration FDA Recruitment Food 52

Legacy MEDSearch

MAY 24, 2022

Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device intended for endoscopic mucosal resections (EMR) and difficult colonoscopies. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.

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Food and Drug Administration FDA Recruitment Food 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.,

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Food and Drug Administration FDA Recruitment Medical 52

PM360

FEBRUARY 12, 2024

Given that less than 10% of rare diseases currently have an available treatment approved by the United States Food and Drug Administration (FDA) , advocating for the speedy development of novel drugs and therapies is a crucial step in improving the quality of life for those affected. What is a Rare Disease?

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Food and Drug Administration Patients Medical Networking 105

Legacy MEDSearch

JUNE 10, 2022

a leading US developer of next gen endoscope systems announces today the US Food and Drug Administration (FDA) has granted 510(k) clearance of its novel integrated 360° field of view colonoscope. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Saneso Inc.,

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FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

SEPTEMBER 11, 2023

Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. Zeta Surgical was founded by Harvard graduates and faculty and is backed by leading investors. Zeta Surgical, a surgical robotics and mixed reality company, announced today that the U.S.

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

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. For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.

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FDA Food and Drug Administration Transportation Recruitment 52

Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). While the drug is marketed in other countries, it is not registered in the US.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

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. Legacy systems for breathing assistance are causing multiple complications leading to physical damage, infection and possible death.

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

APRIL 27, 2023

Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). However, conventional RF devices are not optimized to treat lumpectomy cavities and can lead to variable treatment depths and incomplete ablations. Contact us to discuss partnering with Legacy MedSearch on your position.

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FDA Food and Drug Administration Recruitment Medical 52

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.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

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FDA Food and Drug Administration Recruitment Management 52

Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). Potential benefits include: Reduction in Radiation: Removing the need for high-radiation intraoperative scans throughout the procedure can lead to a 10x reduction in radiation exposure. ” For more information, visit: www.propriovision.com.

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FDA Food and Drug Administration Recruitment Medical 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.

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Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

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.,

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Food and Drug Administration FDA Medical 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). The post FDA Clears ReddyPort® Non-Invasive Ventilation Device appeared first on Legacy MedSearch | Medical Device Recruiters.

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FDA Food and Drug Administration Recruitment Patients 52

Legacy MEDSearch

JUNE 14, 2023

Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. mm to 6 mm in diameter. About Surmodics, Inc.

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FDA Food and Drug Administration Recruitment Medical 52

pharmaphorum

SEPTEMBER 28, 2022

. “What we’re really trying to do is drive discoveries that can lead to more tailored prevention, diagnosis, and treatment for all individuals. This dual approach will lead to better medical research that will benefit all populations.” In March 2020, when the pandemic hit, we had to pause in-person recruitment.

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Medicine Food and Drug Administration Medical FDA 98

Legacy MEDSearch

SEPTEMBER 21, 2023

Food and Drug Administration (FDA) to market the Blackhawk ® Ti 3D Printed Cervical Spacer System with standalone clearance. The post ChoiceSpine® Announces Standalone Indication for Blackhawk® Ti 3D Printed Cervical Spacer System appeared first on Legacy MedSearch | Medical Device Recruiters.

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