European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. What are the top three supply-related challenges facing pharmaceutical manufacturers?

Pharmaceutical 93

Pharmaceutical Food and Drug Administration Transportation Manufacturing 93

Legacy MEDSearch

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.

FDA 52

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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. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography devices. NeuroLogica Corp.,

FDA 92

FDA Food and Drug Administration Electronics Recruitment 92

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. Conversely, in the US, it has always been clear and regulated as a drug.

Food and Drug Administration 96

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Legacy MEDSearch

JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “This submission is another milestone in KORU Medical’s mission to make subcutaneous therapy radically simpler and easier for patients. .

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

Food and Drug Administration 75

Food and Drug Administration Manufacturing Engineering Pharmacology 75

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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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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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.

FDA 95

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DECEMBER 16, 2022

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Manufacturing 52

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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. Our clients include both blue-chip companies and innovative startups within the MedTech space.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

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OCTOBER 3, 2023

ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100).

FDA 52

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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. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process.

FDA 52

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APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery.

FDA 52

FDA Food and Drug Administration Recruitment Manufacturing 52

PM360

AUGUST 9, 2022

Following the annual American Society of Clinical Oncology (ASCO) conference, oncologists were asked how the data presented would impact their care of patients. When asked about driving diversity in clinical trials, 31% of surveyed oncologists felt the best solution is to create a network of clinical trial sites in underserved communities.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

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OCTOBER 25, 2022

NeuroOne Medical Technologies Corporation, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced that it has received U.S. For more information, visit [link].

Marketing 52

Marketing FDA Food and Drug Administration Recruitment 52

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Blockchain technology creates a decentralised and unalterable ledger that records all transactions across a network of computers.

Government 86

Government Pharma Ethics Training 86

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OCTOBER 9, 2023

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process.

FDA 52

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SEPTEMBER 20, 2022

Food & Drug Administration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. The SavvyWire is the first and only Sensor-Guided TAVR solution, designed to support TAVR efficiency and lifetime patient management. OpSens Inc. ,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1. 2] Figure 1.

Food and Drug Administration 52

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AUGUST 10, 2023

Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure.

Food and Drug Administration 52

Food and Drug Administration Management Recruitment Medical 52

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JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. By expanding the treatment range of the Pounce platform we are addressing tibial clots, an important component of treatment in this vulnerable patient population which fills a gap in care.” Surmodics, Inc.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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MAY 18, 2023

Food and Drug Administration has granted the Connexus DDI “Breakthrough Device Designation”, which offers an expedited review process for transformative medical devices with the potential to treat irreversibly debilitating conditions. In addition to the funding, Paradromics announced that the U.S.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

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JULY 11, 2022

Samsara Vision , a company focused on bringing vision and freedom back to patients with late-stage, age-related macular degeneration (AMD) through advanced visual prosthetic devices, announced the completion of the first U.S. It is implanted during typical, out-patient cataract surgery with a corneal incision range between 6.5

Food and Drug Administration 52

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DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel.

Manufacturing 98

Manufacturing FDA Food and Drug Administration Medical 98

Pharmaceutical Technology

NOVEMBER 7, 2022

The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. We are very impressed with the Parkinson’s Foundation’s holistic approach towards improving patient care and supporting cutting-edge research. “We

Food and Drug Administration 98

Food and Drug Administration Food Networking Safety 98

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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., THINK Surgical is committed to an open implant library. ” About THINK Surgical, Inc. THINK Surgical, Inc.,

Specialization 52

Specialization FDA Food and Drug Administration Recruitment 52

European Pharmaceutical Review

FEBRUARY 14, 2023

A key benefit of mRNA therapeutics is that manufacturing time is fast compared to antibodies or protein-based drugs. 2 Yet according to a 2022 report by GlobalData, it is difficult to achieve high quality and highly pure mRNA via scalable manufacturing.

Food and Drug Administration 88

Food and Drug Administration Medicine Safety Consulting 88

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SEPTEMBER 21, 2023

Food and Drug Administration (FDA) to market the Blackhawk ® Ti 3D Printed Cervical Spacer System with standalone clearance. Altus Capital Partners is a private equity firm that controls investments in middle-market manufacturing businesses.

Food and Drug Administration 52

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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. and Europe.

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

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JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. percentage of patients with conclusive reports) without the need for dilation.

FDA 52

FDA Food and Drug Administration Recruitment Marketing 52

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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.

FDA 95

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Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Tyber Medical is committed to providing rapid access to FDA-cleared and CE-marked private label, orthopedic device technology that advance patient care and healing outcomes. About Tyber Medical LLC.

Medical 98

Medical FDA Food and Drug Administration Engineering 98

Pharmaceutical Technology

JUNE 30, 2022

The country also offers timely patient recruitment due to a population of nearly 4 million, many of whom are treatment-naïve. This will put up a barrier to the traditional system where the drugs are shipped on a direct-to-site basis straight away from the manufacturing facilities to a Georgia storage facility within the location.”.

Food and Drug Administration 52

Food and Drug Administration Distribution Recruitment Transportation 52

Pharma Marketing Network

JUNE 11, 2020

You know, in November 2009, the FDA held a public hearing about the promotion of Food and Drug Administrative Related Regulated Medical Products, using the internet and social media tools. They would write up the presentations by physicians about drugs. So, I didn’t look so bad. So, I was actually presenting there.

Media 52

Media Pharma Ethics Consulting 52