European Pharmaceutical Review

FEBRUARY 27, 2024

The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen. ” Amgen Ohio is nearly 300,000 ft 2 in size and will employ 400 full-time staff.

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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.

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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.

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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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European Pharmaceutical Review

JULY 17, 2023

billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. million publications describing basic or applied research related to 386 of 387 drugs approved 2010-2019 with $8.1 million per approved drug. billion (3.3 Average NIH spending was $33.8

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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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. ” About IRRAS.

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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. About Pulse Biosciences®. in the United States and other countries. Press Release by: Pulse Biosciences.

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MARCH 27, 2023

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. The LCD screen on the handle of the device allows the physician to visualize internal patient anatomy in line with instrument insertion. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device.

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NOVEMBER 14, 2022

Food and Drug Administration (FDA). IntraOpVSP displays patient CT and MRI as three-dimensional holograms in AR headsets, helping surgeons visualize surgical plans, anatomical targets, and cutting guides alongside or overlayed on the patient. Food and Drug Administration cleared the software for use in 2022.

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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., Are you hiring?

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Pharmaceutical Technology

MAY 1, 2023

In February this year, the US Food and Drug Administration (FDA) accepted for filing the company’s new drug application (NDA) for Avacincaptad Pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

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SEPTEMBER 12, 2023

Food and Drug Administration (FDA) has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation. At LimFlow, our vision is to achieve great outcomes for patients suffering from CLTI. “At

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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.

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OCTOBER 10, 2023

Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced today that it has received clearance from the Food and Drug Administration for its Hammerdesis Interphalangeal Fusion System. This is a truly disruptive technology in a crowded area. Are you hiring?

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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.”

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JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc., 1 ranking in 2021.

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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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Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. The drug works by blocking an enzyme known as BACE1, which is responsible for producing beta-amyloid.

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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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Pharmaceutical Technology

MAY 17, 2023

WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients. Last month, the therapy received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to treat hospitalised Covid-19 adult patients.

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NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. See Full Press Release at the Source: NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64. Press Release by: NeuroLogica. Are you hiring?

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MARCH 21, 2023

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc.,

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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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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 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

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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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AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

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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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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 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. “With this FDA clearance, we eagerly anticipate making a substantial impact across the value chain.”

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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

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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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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.” and projected to impact 70 million Americans by 2040.

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JULY 14, 2023

AlloSource ® , one of the largest allograft providers creating innovative cellular and tissue products to help surgeons heal their patients, today announced the U.S. Food and Drug Administration’s 510(K) clearance of AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation.

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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. For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.

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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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