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OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

Food and Drug Administration 98

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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

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MARCH 22, 2023

Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan® , the non-invasive liver management technology by Echosens. Measurement interpretation has been expanded to all physicians with appropriate training. ” Age has been removed as the first selection probe and exam-type step.

Management 52

Management FDA Food and Drug Administration Physicians 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

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OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.

FDA 52

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JUNE 20, 2023

Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. BabySat is a step forward in solving some of these exact challenges by bringing real-time medical grade infant monitoring into the home, while under the supervision of a physician. Are you hiring?

Prescription 52

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JUNE 19, 2023

The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis.

FDA 52

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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. For more information, see www.medinol.com. Are you hiring?

Food and Drug Administration 52

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Legacy MEDSearch

MARCH 17, 2023

a health technology company equipping primary care physicians (PCPs) with a non-invasive device for use in evaluation of suspicious skin lesions, presented a pooled analysis today from two clinical studies evaluating the performance of the company’s device in detecting skin cancer. DermaSensor Inc. , About DermaSensor DermaSensor Inc.

FDA 52

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NOVEMBER 14, 2022

Food and Drug Administration (FDA). Current and planned use cases for IntraOpVSP are expected to align to the needs of physicians across general, craniofacial and maxillofacial, neuro, orthopedic, plastic, thoracic and vascular surgery disciplines. Food and Drug Administration cleared the software for use in 2022. Are you hiring?

Food and Drug Administration 52

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JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The novel Reverse HRS is now beginning enrollment in the FDA IDE clinical trial with multiple outcome measures being evaluated.” Press Release by: Hip Innovation Technology. Are you hiring?

FDA 98

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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. Hyperfine, Inc.,

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

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JUNE 12, 2023

Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (AST) solutions announced today the submission of its eQUANT TM system for FDA 510(k) clearance. In addition to FDA submission, Avails Medical also announced today an additional $5.4M and other countries. and other countries.

FDA 52

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JULY 27, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. TIGERTRIEVER 17 and 21, COMANECI , and COLUMBUS /DRIVEWIRE are CE marked and FDA cleared.

Medical 52

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AUGUST 29, 2022

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt ® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). . CereVasc, Inc., Press Release by: CereVasc. Are you hiring?

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OCTOBER 4, 2023

Stimdia Medical, a medical device company developing innovative technologies to improve respiratory care, today announced the initiation of its FDA approved pivotal trial to investigate the impact of phrenic nerve stimulation (PNS) on the time to liberate patients from mechanical ventilation. Are you hiring? The post Stimdia Medical Inc.

Medical 52

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APRIL 27, 2023

Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). ” About Innoblative Innoblative is a medical device company dedicated to innovating advanced-energy solutions that improve the way physicians treat breast cancer and other soft tissue diseases. Are you hiring?

FDA 52

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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. Press Release by: Cytovale. Are you hiring?

Food and Drug Administration 98

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JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of its Zoom RDL Radial Access System, the company’s latest innovation in elevating stroke care and the first radial access platform developed specifically for ischemic stroke treatment. Imperative Care, Inc., announced U.S. The Zoom RDL provided.088” Press Release by: Imperative Care.

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AUGUST 21, 2023

About Exactech Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., With Exactech by your side, you’ve got EXACTLY what you need.

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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., Are you hiring?

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MAY 12, 2023

Novarad’s VisAR, a surgical navigation system that uses augmented reality, has received clearance from Indonesia’s FDA for intraoperative use in stereotactic spinal surgery. With VisAR, physicians wear the wireless Microsoft HoloLens 2 visor and have no need for any other navigational equipment. Are you hiring?

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JULY 6, 2022

expects to further accelerate its global market presence and entry into the US market following recent FDA approvals for part of its comprehensive radiology AI product. Earlier this year, Annalise Enterprise CXR received CADt FDA clearance for use in triage and notification of pneumothorax and tension pneumothorax on chest X-rays.

Healthcare 52

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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”) announce the U.S.

Medical 52

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APRIL 19, 2023

Leading the next evolution of clinical decision-making and patient workflow, RapidAI is empowering physicians to make faster decisions for better patient outcomes. RapidAI – where AI meets patient care. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process.

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SEPTEMBER 20, 2022

Food & Drug Administration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. For OpSens, FDA clearance is a key milestone and an achievement, introducing an entirely new category of innovation to the structural heart device market segment. OpSens Inc. ,

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DECEMBER 16, 2022

Food & Drug Administration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System. Utilizing expandable technology and robust plating options, TruLift Lateral and Lateral Plate System provide physicians with unique possibilities for their patient care. Press Release by: Life Spine. Are you hiring?

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JUNE 9, 2023

Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). “We are delighted to receive FDA approval of the DETOUR System,” said Matt Thompson, MD, President, and CEO of Endologix. million Americans are affected by PAD. Are you hiring?

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MARCH 15, 2023

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring.

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FEBRUARY 24, 2023

“During a routine physical exam, patients can now have access to advanced structural murmur detection and arrhythmia assessment by their primary care physician in seconds, making early intervention possible for millions of patients with silent cardiovascular disease. Older adults have a 1 in 10 chance of developing clinically significant VHD.

Physicians 98

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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. Pacifico, Founding President and Chief Executive Officer of Abyrx.

FDA 52

FDA Food and Drug Administration Recruitment Manufacturing 52

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.

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JUNE 28, 2023

Director of the Laser & Skin Surgery Center of New York ® , who provided a recommendation letter to the FDA for clearance of Candela’s Vbeam Family of 595 nm PDLs in the pediatric population. 1 Early treatment of PWS during childhood leads to the best clinical response. ”, states board-certified cosmetic dermatologist, Roy G.

Medical 52

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OCTOBER 13, 2022

Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. With HFX iQ, our goal is to provide physicians and patients the personalization needed to achieve and maintain the best possible long-term outcomes. We believe HFX iQ represents the future of SCS therapy.” this quarter, with a broad U.S.

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APRIL 14, 2023

Northwell Holdings, the venture investment arm of Northwell Health, Topspin Fund, and Long Island Angel Network also participated in the round. This funding will be used by Neuvotion to further expand its team, complete clinical studies, and obtain FDA clearance for its initial product. ” About Neuvotion, Inc.

Engineering 52

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OCTOBER 17, 2023

The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is critical that physicians have tools to rapidly detect DOACs so they definitively know whether to proceed with drug reversal to safely manage patients. Are you hiring?

Food and Drug Administration 52

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PM360

NOVEMBER 12, 2023

Macroeconomic Factors The pandemic really changed the game, driven by several disruptions that changed physician and patient behavior forever. 3 However, research from IQVIA suggests that physicians who are comfortable treating and managing patients online are reluctant to start a new drug online.

Physicians 64

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