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FEBRUARY 28, 2023

RADIANCE II is a randomized, sham-controlled US FDA IDE pivotal trial of the Paradise uRDN System in the treatment of patients with uncontrolled hypertension. Results of the pooled analysis showed a consistent blood pressure lowering effect across a broad range of hypertension, including mild to moderate and resistant hypertension.

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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.

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APRIL 6, 2023

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. Icentia Inc., “This approval marks a key milestone for our company.

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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.

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DECEMBER 8, 2022

Food and Drug Administration (FDA). “FDA clearance is a significant milestone towards the commercialization of Polso CONNECT and towards creating a new model in chronic care management,” said ChroniSense Medical CEO, Bridget Ross. “FDA clearance is an important validation of our technology. Are you hiring?

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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.

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Contrarian Sales Techniques

JANUARY 23, 2024

Craving a career in the lucrative world of pharmaceutical sales? So, strap yourselves in because I'm here to peel back the CNPR curtain, tell you the good, the bad, and the pharmaceutical, and equip you with the intel you need to crack the code to pharmaceutical sales success. Let's dissect the program itself, shall we?

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NOVEMBER 28, 2022

Director of Global Sales and Marketing of NeuroLogica. 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. About NeuroLogica. NeuroLogica Corp., the healthcare subsidiary of Samsung Electronics Co.,

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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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SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. This action is part of the FDA’s ongoing effort to ensure the safe and effective use of blood lancets in the home and health care settings. Tasso, Inc., For more information, please visit www.tassoinc.com. Press Release by: Tasso, Inc.

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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. .

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JANUARY 9, 2023

Lydus Medical is pleased to announce that the Vesseal has received FDA clearance 510(k). “FDA clearance of the Vesseal is a significant milestone both for innovation in microvascular anastomoses, and for Lydus Medical. Lydus Medical’s pipeline includes a diverse product portfolio, all based on patented inventions.

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OCTOBER 10, 2023

Our product development and sales teams are looking forward to being a part of this market transformation that will make a major impact for surgeons and their patients for many years to come. .” President of Intelivation, Amit Sinha, added, “There is nothing on the market today like the Hammerdesis procedure. Are you hiring?

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

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MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. The post Vivasure Medical Announces FDA IDE Approval to Initiate U.S.

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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?

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NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. “We are pleased to receive another FDA clearance that extends our reach into the orthopedic device market with our ever-growing suite of cleared bone-fixation devices,” said Tyber Medical CEO and President Jeff Tyber.

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JULY 25, 2023

Currently, Numares is the only company in the US selling an FDA-cleared NMR test. The FDA clearance also includes the company’s core technology platform, the proprietary AXINON ® System, that incorporates diagnostic testing algorithms into nuclear magnetic resonance (NMR) spectroscopy. Are you hiring?

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DECEMBER 5, 2022

WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), announced the FDA clearance of its WISE Cortical Strip (WCS®) , a single use medical device intended to be used on the brain surface for Intra Operative Neurophysiological Monitoring (IONM).

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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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JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

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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. 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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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 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.

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

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JANUARY 10, 2023

a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. . Food and Drug Administration (FDA). VERO Biotech Inc., VERO Biotech Inc. Press Release by: VERO Biotech.

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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?

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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 solution is not yet approved for sale or distribution in the USA and is limited by USA law to investigational use.

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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.

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OCTOBER 27, 2023

Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers. FDA in April 2023 for use with an implant from a single implant manufacturer. THINK Surgical, Inc., For additional product information, please visit www.thinksurgical.com. Are you hiring?

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SEPTEMBER 11, 2023

Dr. William Gormley, Chief Medical Officer of Zeta Surgical and Harvard Medical School Associate Professor, commented on the clearance: “The FDA’s market clearance of the Zeta Navigation system ushers in the next generation of innovation to neurosurgery. To learn more, visit: www.zetasurgical.com. 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.

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JANUARY 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the Flex-Thread Ulna Intramedullary (IM) Nail System. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

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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 21, 2022

Food and Drug Administration (FDA) for 510(k) clearance. If FDA clearance is obtained, the ALICE device production line will be extended for Low-Rate Initial Production (LWRIP), which is an important operational stage in developing infrastructure to support serial manufacturing, quality control and shipping. Are you hiring?

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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., FemDx Medsystems, Inc.,

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