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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. . Are you hiring?

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SEPTEMBER 18, 2023

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites. CereVasc, Inc., Carl Heilman, M.D., and Adel Malek, M.D.,

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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. About Potrero Medical. Potrero Medical, Inc.

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JUNE 9, 2023

Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). At present, patients with long blockages of the superficial femoral artery (SFA) have limited treatment options. million Americans are affected by PAD.

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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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NOVEMBER 1, 2022

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. The new 7.5mm device is designed to simplify surgery and to provide strong, stable, curved fixation in smaller patients. CurvaFix, Inc., every year. About CurvaFix, Inc. CurvaFix, Inc.

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APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR metal resection guides sit noticeably better on the bone and offer greater saw control compared to the historically polymer patient-specific instruments.

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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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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. With more than 8 million patients admitted to U.S. In addition, approximately 30 million heart disease patients in the U.S.

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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. “Enable’s purpose is to redefine drug delivery for the benefit of patients.

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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). 1 The ReddyPort elbow also enables patients and clinicians to use the ReddyPort microphone.

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OCTOBER 10, 2023

Hammerdesis allows surgeons to correct hammertoe deformities and degenerative issues in patients by simply affixing a distinctively designed implant on the patient’s toe joint. Dr. David Murphy, DPM FACFAS remarked, “ Hammerdesis provides patients with a more reliable, and a more consistent option to fix hammertoe issues.

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JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung Expansion (OLE) therapy. We are proud to introduce this innovative OLE therapy system.” Are you hiring?

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JANUARY 31, 2023

The newly approved Axonics R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour. This compares to the third-generation’s recharge interval of once a month for one hour.

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JANUARY 13, 2023

Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics.

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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. Klimstra, M.D.,

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OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). The Seraph 100 is a patented blood filter containing a biomimetic surface, similar to that found in the human circulatory system that removes pathogens that could otherwise overwhelm a patient; a common source of severe/critical illness.

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DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today.

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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. This system fills that void for both surgeons and patients.” For these patients, total knee replacement is a reluctant option, as it is an end-stage treatment for end-stage disease.

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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. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.

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NOVEMBER 28, 2022

The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. 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. Press Release by: NeuroLogica. Are you hiring?

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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 2, 2023

Xēnix Medical, a surgical implant company focused on the development of novel science-based solutions for patients requiring spinal fusion surgery, today announced that it has received 510(k) clearance from the U.S.

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AUGUST 22, 2023

Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration (FDA) clearance for its MARS platform. “Today marks a significant milestone in Levita’s mission to provide more patients access to state-of-the-art surgical technology.

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JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

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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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FEBRUARY 8, 2023

market with a breakthrough FDA-Class II medical device, TargetCool. This allows providers to combine TargetCool with other needle-based procedures to minimize patient pain, bruising, inflammation and hematoma that may occur post-procedure. Reviews from early-adopters and their patients have been immensely positive. Recens, Inc.

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AUGUST 15, 2022

This first-generation anatomical segment analysis tool emerged over 10 years ago from research aimed at detecting subtle volumetric and shape abnormalities in patients with mild traumatic brain injury. More importantly, it provides point-based correspondence longitudinally and across patients. About ClearPoint Neuro.

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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. The approval provides patients implanted with the Evoke ® System the ability to undergo 1.5 head and extremity and 1.5T

Medical 52

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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.

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Pharma Marketing Network

MAY 3, 2023

However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

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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 “We are excited to receive 510(k) clearance for our VisAble.IO The BioTrace.IO

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MARCH 16, 2023

The DeltaScan Brain State Monitor provides a quick and objective measurement of acute brain failure even before symptoms appear, enabling clinicians to provide immediate treatment and help patients regain cognitive well-being. It’s clear from the evidence that minimizing the duration of acute brain failure can improve outcomes.”

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OCTOBER 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. ACES focuses on patient-centered outcomes, potentially eliminating the need for a long hospital stay and chronic drainage at home. This is a potentially perfect solution,” said David Feller-Kopman, M.D.,

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AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. per eligible Medicare patient case.

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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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DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The LimiFlex DST is the first-of-its-kind minimally invasive, outpatient surgical option for this specific patient population. The study, which enrolled 299 patients across 27 U.S. Empirical Spine, Inc., About LimiFlex.

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