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JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. See Full Press Release at the Source: ABM RESPIRATORY CARE ANNOUNCES THE FDA CLEARANCE OF THE BIWAZE CLEAR SYSTEM. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Are you hiring?

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DECEMBER 12, 2022

This most recent FDA 510(k) clearance extends the system’s previous FDA clearances and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station. For more information, please visit www.irras.com. Are you hiring?

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NOVEMBER 1, 2022

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. With this latest FDA clearance, we are able to offer surgeons the CurvaFix Implant in two diameters, 7.5mm and 9.5mm, and in lengths ranging from 90mm to 180mm,” said Steve Dimmer , chief executive officer.

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NOVEMBER 28, 2022

BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. See Full Press Release at the Source: NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64. About NeuroLogica. NeuroLogica Corp.,

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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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NOVEMBER 7, 2022

a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Allotrope Medical Inc.,

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OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). It additionally signals that the FDA is already thinking about future pandemic preparedness, something we are keen to partner on with them and the medical community.” “I RAC & Chief Regulatory Officer for ExThera. Are you hiring?

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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. Dagi Ben-Noon , CEO of Inspira, stated that, “We are preparing for global deployments of our INSPIRA ART100 systems once FDA clearance is achieved. Are you hiring?

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JANUARY 31, 2023

See Full Press Release at the Source: Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System Press Release by: Axonics Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. For more information, visit www.axonics.com. Are you hiring?

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OCTOBER 2, 2023

Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. Food and Drug Administration (FDA) Approval appeared first on Legacy MedSearch | Medical Device Recruiters.

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OCTOBER 10, 2023

See Full Press Release at the Source: FDA clears Intelivation Technologies new Hammerdesis Interphalangeal Fusion System Press Release by: Intelivation Technologies Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Are you hiring?

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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. Are you hiring?

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MARCH 1, 2024

Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. The FDA’s approval was largely based on data from the AGENT IDE trial, which compared treatment with the AGENT DCB to traditional balloon angioplasty. Are you hiring?

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NOVEMBER 1, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Paige Lymph Node 1 , an AI application used to detect breast cancer metastases in lymph node tissue. Paige Lymph Node is the first AI application of its kind to receive Breakthrough Device Designation from the FDA. Are you hiring? The post U.S.

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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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DECEMBER 16, 2022

In comparing the overall accuracy of the ring’s data with data from the study’s reference devices, Movano Health’s ring resulted in an approximate 2% margin of error, well below the FDA consensus standard of 4% for SpO 2. Given these positive results, Movano Health expects to file for FDA clearance of these metrics in 2023.

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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.”

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JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. ” said Cresilon CEO and Co-Founder Joe Landolina.

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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.

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MARCH 27, 2023

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. Receives FDA Clearance For Its FalloView™ Falloposcope appeared first on Legacy MedSearch | Medical Device Recruiters. FemDx Medsystems, Inc., Are you hiring?

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FEBRUARY 8, 2023

market with a breakthrough FDA-Class II medical device, TargetCool. Market With TargetCool™, A Breakthrough FDA-Class II Medical Device Offering Unprecedented Precise, Rapid Cooling For Pain Management And Bruise Minimization appeared first on Legacy MedSearch | Medical Device Recruiters. Recens, Inc.

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DECEMBER 1, 2022

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. The FDA clearance of the QStat Cartridge expands the Quantra System’s indications for use to include trauma, and liver transplantation procedures. market today. “Point-of-care data is the answer to PBM-guided patient decisions.

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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?

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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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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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AUGUST 22, 2023

Food and Drug Administration (FDA) clearance for its MARS platform. “With this FDA clearance, we eagerly anticipate making a substantial impact across the value chain.” The post Levita® Magnetics Wins FDA Clearance for Pioneering MARS™ System appeared first on Legacy MedSearch | Medical Device Recruiters.

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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. Moximed is based in Fremont, California. Are you hiring?

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OCTOBER 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. With this FDA 510(k) clearance, Pleural Dynamics will begin real-world clinical use of the ACES System with select hospitals and health systems. Contact us to discuss partnering with Legacy MedSearch on your position.

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JUNE 29, 2023

US Medical Innovations, LLC (USMI) , a Biomedical and Life Science subsidiary of US Patent Innovations, LLC, announced today it has received FDA Approval for its Canady Flex RoboWrist to be used in open and laparoscopic procedures in the United States. The device is already approved and used in the Middle East, Europe, and Asia.

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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. Are you hiring?

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SEPTEMBER 26, 2023

Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. To learn more, including risks & important safety information, visit www.saludamedical.com/us/safety/. Are you hiring?

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

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MAY 22, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The designation allows a collaborative and streamlined review pathway with FDA so the Orlucent technology can get to the market faster. Orlucent, Inc., president of Orlucent. Are you hiring?

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JULY 11, 2023

Invictus Medical announced today that the culmination of their De Novo application to the FDA for its Neoasis ® incubator-based active noise control (ANC) device has resulted in a clearance-for-use declaration by the FDA. For more information about Invictus Medical, please see www.invictusmed.com. Are you hiring?

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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.

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NOVEMBER 14, 2022

Food and Drug Administration (FDA). See Full Press Release at the Source: Xironetic Receives FDA Clearance for Augmented Reality Surgical Software. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Follow our progress at [link] and connect with us on LinkedIn.

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JUNE 24, 2022

The FDA has ordered a clinical hold on Sarepta’s SRP-5051 (vesleteplirsen) drug candidate after one patient in the study developed very low levels of magnesium, a condition known as hypomagnesaemia, that can lead to muscle weakness and tremors, seizures, and irregular heart rhythms.

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