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

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

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

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

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

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.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

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

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

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 Medical 105

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 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. This delay often leads to cognitive impairment, worse health outcomes, and increased costs,” said Dr. .

FDA 52

FDA Food and Drug Administration Patients Recruitment 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. Otsuka Medical Devices Co.,

Medical 52

Medical Food and Drug Administration FDA 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

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

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.

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.

FDA 52

FDA Food and Drug Administration Recruitment Patients 52

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.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Physicians 98

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. . The post KORU Medical Systems, Inc.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

Legacy MEDSearch

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). The post Innoblative Receives U.S.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

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.”

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 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.” OA patients without end-stage disease seek options that preserve their knee, activity level, and quality of life.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

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 Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52

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., ” Other hemostatic agents swell after application.

Food and Drug Administration 97

Food and Drug Administration FDA Recruitment Medical 97

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.

FDA 52

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

Food and Drug Administration 52

Food and Drug Administration FDA Medical Recruitment 52

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 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.

FDA 52

FDA Food and Drug Administration Recruitment Patients 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%

Pharma 105

Pharma Food and Drug Administration Government Medicine 105

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

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

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

JUNE 13, 2023

CorNeat Vision’s EverPatch , a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). This groundbreaking synthetic tissue substitute is designed to address the critical needs of ocular surgeons, providing a sterile and non-degradable solution for patients worldwide.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery.

FDA 52

FDA Food and Drug Administration Recruitment Manufacturing 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.

Food and Drug Administration 84

Food and Drug Administration Government Management Medicine 84

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1. 2] Figure 1.

Food and Drug Administration 52

Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Legacy MEDSearch

FEBRUARY 16, 2023

a developer of medical devices to repair fractures in curved bones, announced the launch of its smaller-diameter, 7.5mm CurvaFix® IM Implant , designed to simplify surgery and provide strong, stable fixation in small-boned patients. patient who sustained a low energy fall two years prior, resulting in pelvic fragility fractures.

Food and Drug Administration 52

Food and Drug Administration Recruitment Patients Medical 52

Legacy MEDSearch

APRIL 6, 2023

With the cost effectiveness and demonstrated ability of our cardiac monitoring solution to provide effective patient care and outcomes, we have no doubts that CardioSTAT will make a meaningful difference in the diagnosis of patients with cardiac disorders in the United States.”, Are you hiring? The post Icentia Receives U.S.

Food and Drug Administration 98

Food and Drug Administration Food FDA Recruitment 98