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In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kis | In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients (..)
The FDA is apparently open to new technologies that enable patients to easily participate in clinical research, whether it be from their homes, a nearby clinic, or a provider’s office.
More than 18,000 clinical trials are actively recruiting patients in the U.S. The FDA approved 309 new drugs between 2011 and 2018, 38 per year on average. In 2018, the FDA approved 59 new drugs – an all-time high. We’ve been asked, a lot of times, to give our opinion on using DTC for clinical trial recruitment.
Combined, DTx and DCTs improve patient recruitment, retention, and access, allowing researchers to pull from underserved communities, including rural populations. This strategy eliminates the per-unit sticker price, but at the cost of losing the FDA credibility. The result was more diverse and inclusive data.
The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.
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. For more information, visit potreromed.com .
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.
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.
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.
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. .
About five years ago, I was recruited to be the lead on establishing a digital marketing department at a biotech that had received approval for their drug by the FDA. ” I turned the job offer down and now executives are bailing left and right as the FDA has started to question some of their data.
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. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.
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.
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).
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?
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?
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.
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.,
FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. The Hummingbird® Tympanostomy Tube System (TTS) is FDA 510(k) cleared for use in children 6 months and older. Preceptis Medical, Inc., Press Release by: Preceptis Medical. Are you hiring?
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.
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.,
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?
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.
In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.
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.
Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. Throughout the pandemic, the lack of FDA inspections has created new challenges and heightened existing problems, largely due to delays in upgrading legacy facilities. Upgrading facilities. Ensuring GMP readiness. About the Author.
Food and Drug Administration (FDA) 510(k) clearance for the Flex-Thread Ulna Intramedullary (IM) Nail System. The post Conventus Flower Orthopedics Announces Expansion of its Flex-Thread™ Technology Platform with FDA Clearance of the Ulna Intramedullary Nail System appeared first on Legacy MedSearch | Medical Device Recruiters.
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. See Full Press Release at the Source: ClearPoint Neuro Announces FDA Clearance for ClearPoint Maestro Brain Model. For more information, please visit www.clearpointneuro.com.
Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. Announces FDA Clearance for FreedomFlow® Peripheral Guidewire, plus First Commercial Case Completed in U.S. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.
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.
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.
See Full Press Release at the Source: Candela Introduces the New FDA-Cleared Profound Matrix System Press Release by: Candela Medical Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Are you hiring? Contact us to discuss partnering with Legacy MedSearch on your position.
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.
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.,
On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.
See Full Press Release at the Source: Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for use in CLIA waived settings. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Follow Visby Medical on LinkedIn. Press Release by: Visby Medical.
Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. See Full Press Release at the Source: Aerin Medical Receives FDA Clearance of Next-Generation RhinAer® Stylus for Treatment of Patients with Chronic Rhinitis. Aerin Medical Inc., Press Release by: Aerin Medical.
Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers. The X1 also has a state-of-the-art anatomic modality previously cleared by the FDA for solid tumors located anywhere in the body.
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?
It must convert visitors into leads , provide clear and accurate medical information , and ensure compliance with FDA, HIPAA, and ad platform policies. The Role of Landing Pages in Pharma Marketing HCP Engagement: Used for medical education, clinical trial recruitment, and drug sample requests. Heres how to ensure yours is effective.
Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO ® Vascular Occlusion System. LOBO-3 and LOBO-5, both previously FDA cleared, are intended for use in 1.5 Okami Medical Inc., Okami Medical – LOBO Vascular Occlusion System.
Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The device previously received the FDA’s Breakthrough Designation for its potential to provide significant advantages over currently approved spinal stabilization technologies. Empirical Spine, Inc., About LimiFlex.
We brought together three leaders who are working to change these statistics by bringing recruitment to the patient and leveraging real-world evidence (RWE) to innovate trial design and accelerate recruitment. With real-world data, you can see that pattern clearly and more precisely recruit the right patients into the trial.”.
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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