Legacy MEDSearch

OCTOBER 24, 2023

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. “The FDA’s Breakthrough Device Designation is a testament to the potential of our technology to address a critical unmet need in interventional cardiology,” said Dr. Mehran Khorsandi, CEO of Advanced Bifurcation Systems.

FDA 52

FDA Food and Drug Administration Recruitment Food 52

Legacy MEDSearch

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?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Legacy MEDSearch

SEPTEMBER 13, 2022

Potrero Medical announced that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients. Potrero Medical is headquartered in Hayward, CA.

Medical 98

Medical FDA Recruitment Management 98

Legacy MEDSearch

SEPTEMBER 27, 2022

Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. See Full Press Release at the Source: Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia.

FDA 98

FDA Food and Drug Administration Recruitment Medicine 98

Legacy MEDSearch

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

Food and Drug Administration FDA Side effects Recruitment 98

Legacy MEDSearch

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. For more information visit, www.abmrc.com. . Press Release by: ABM Respiratory Care. Are you hiring?

FDA 95

FDA Food and Drug Administration Recruitment Management 95

Legacy MEDSearch

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.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

Legacy MEDSearch

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.

FDA 52

FDA Recruitment Distribution Healthcare 52

Legacy MEDSearch

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.,

FDA 92

FDA Food and Drug Administration Electronics Recruitment 92

Legacy MEDSearch

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

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. Allotrope Medical Inc., For the past year, StimSite has been used by surgeons to help locate and identify ureters through electrical stimulation.

Medical 95

Medical FDA Safety Recruitment 95

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. 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?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

MARCH 29, 2023

a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. has raised over $20 million so far from investors such as Accel, University of California – Ratan Tata Fund, Omidyar Network, TrueScale capital and Chiratae Ventures.

FDA 52

FDA Food and Drug Administration Recruitment Networking 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

Safety Food and Drug Administration FDA Side effects 59

Legacy MEDSearch

JULY 27, 2023

UltraSight , a digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced that it has been granted FDA clearance for its AI-powered ultrasound guidance technology. ” Additionally, the company was awarded a patent for its real-time guidance solution for ultrasound devices.

FDA 52

FDA Recruitment Medical Patients 52

Legacy MEDSearch

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.

FDA 52

FDA Recruitment Medical Healthcare Provider 52

Legacy MEDSearch

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.

Food and Drug Administration 52

Food and Drug Administration Food FDA Recruitment 52

Legacy MEDSearch

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.

FDA 52

FDA Food and Drug Administration Recruitment Management 52

Legacy MEDSearch

NOVEMBER 2, 2023

Food and Drug Administration (FDA) to market the SOLACE Sacroiliac Fixation System with proprietary NANOACTIV surface technology and compatibility with StealthStation ® Navigation. The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document. Are you hiring?

Medical 52

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

FDA 52

FDA Food and Drug Administration Recruitment Patients 52

Legacy MEDSearch

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. Reimbursement coverage is well established in the U.S. Are you hiring?

FDA 98

FDA Food and Drug Administration Recruitment Medical 98

Legacy MEDSearch

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?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

Legacy MEDSearch

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

FDA Safety Recruitment Patients 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. The FDA clearance of BAROguard is a major step in providing transplant teams with leading technology to enhance organ transplantation outcomes.”

FDA 52

FDA Food and Drug Administration Transportation Recruitment 52

Legacy MEDSearch

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

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.

FDA 98

FDA Recruitment Medical Healthcare 98

Legacy MEDSearch

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., FemDx Medsystems, Inc.,

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Legacy MEDSearch

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

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.

Medical 52

Medical FDA Healthcare Provider Healthcare 52

Legacy MEDSearch

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

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.

FDA 52

FDA Food and Drug Administration Recruitment Management 52

Legacy MEDSearch

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.

FDA 95

FDA Food and Drug Administration Recruitment Medical 95

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. 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?

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 Techsomed Ltd., The BioTrace.IO Our clients include both blue-chip companies and innovative startups within the MedTech space.

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52

Legacy MEDSearch

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

Food and Drug Administration FDA Distribution Recruitment 52

Legacy MEDSearch

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.

FDA 52

FDA Recruitment Medical Management 52

Legacy MEDSearch

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?

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52