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SEPTEMBER 7, 2023

FDA clearance for distribution in the United States. FDA approval, coupled with strategic partnerships like the one with AstraZeneca, positions alveofit® for broader international expansion, particularly in the U.S. FDA-cleared, portable digital spirometer, alveoair® is part of alveofit’s ecosystem. and emerging economies.

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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. ” About Inspira Technologies OXY BHN Ltd. Are you hiring?

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JANUARY 31, 2023

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. The post Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System appeared first on Legacy MedSearch | Medical Device Recruiters.

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JULY 12, 2023

AccurKardia , a medical technology company delivering clinical-grade ECG interpretation software, announced today that its flagship product, the AccurECG Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance. It is indicated for adults aged 22 and older.

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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 ReddyPort elbow safely delivered 45,000 compliant oral care sessions to patients under FDA Emergency Use Authorization (EUA). Are you hiring?

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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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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.” About Hip Innovation Technology, LLC.

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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.,

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JULY 31, 2023

Axial3D, a leader in medical segmentation and 3D solutions, today announced that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications.

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APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Also, we recognize the dedicated reviewers at FDA for completing their thorough benefit-risk assessment of our breakthrough technology. and projected to impact 70 million Americans by 2040.

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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 The BioTrace.IO Are you hiring? Contact us to discuss partnering with Legacy MedSearch on your position.

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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. “The global emergence of superbugs and rise in antimicrobial resistance is a leading public health concern. and other countries.

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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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AUGUST 15, 2022

The unique shape representation in Maestro will provide reproducible lead placement for deep brain stimulation and micro electrode recording. The ClearPoint® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 60 active sites in the United States, Canada, and Europe. Press Release by: ClearPoint Neuro.

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SEPTEMBER 8, 2023

a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the United States. Aquedeon Medical, Inc.,

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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. ABOUT PROPRIO Proprio is a leading medical technology company creating the new way of seeing in surgery.

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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. For more information, visit Innoblative.com. Are you hiring?

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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 recent FDA clearance of our first device for ophthalmic use advances us toward our ultimate goal of promoting human health and equality.” Click HERE to learn more.

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AUGUST 21, 2023

Muratoglu invented the first crosslinked polyethylene, and the first of multiple generations of vitamin E, antioxidant polyethylene for leading orthopaedic companies. “We The post Exactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene appeared first on Legacy MedSearch | Medical Device Recruiters.

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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.

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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. 1 The risk of death from sepsis increases by as much as 8 percent each hour the condition goes untreated.

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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. “VisAR’s FDA approval in Indonesia is a testament to its innovative design and ability to improve patient outcomes. Are you hiring?

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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. 4 The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA. “At

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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.

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JUNE 6, 2023

FDA 510(k) clearance of FlexBand®, FlexPatch®, and FlexBand Plus® for ligament repair surgery in addition to tendon repairs*. ’s FlexBand®, FlexPatch®, and FlexBand Plus® earn FDA Clearance for Ligament Reinforcement Press Release by: Artelon, Inc. Artelon Inc., announced today U.S. ankle instability market. Are you hiring?

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Pharmaceutical Technology

JUNE 30, 2022

In Germany, pharma companies like Bayer and Merck KGaA are members of the German Network against Neglected Tropical Diseases. In July 2021, the FDA approved the use of Fexinidazole, a once-daily oral treatment for sleeping sickness. For example, Merck & Co. Fraisse considers the product a flagship for DNDi’s efforts.

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JUNE 28, 2023

1 Early treatment of PWS during childhood leads to the best clinical response. 1 Early treatment of PWS during childhood leads to the best clinical response. 5 In fact, the Vbeam 595 nm PDL has been chosen by leading hospitals, 8 out of 10 of the top U.S. ”, states board-certified cosmetic dermatologist, Roy G. .”,

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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.

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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.

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JULY 6, 2023

Food and Drug Administration (FDA). More than half of stroke survivors aged 65 and older experience reduced mobility, and stroke has become a leading cause of long-term disability. InTandem, which is designed to be used independently by a patient in a home setting, received Breakthrough Device Designation from the FDA in 2020.

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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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DECEMBER 12, 2022

Highmark), one of America’s leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, will conduct a targeted Coverage with Evidence program with the goal of providing its members with affordable treatment for episodic and chronic migraine. Press Release by: Theranica.

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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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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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Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

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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. At Sandoz, we are determined to continue leading the way in driving access to these critical medicines.

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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.

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