Legacy MEDSearch

JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. mm to 6 mm in diameter.

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

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.

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FDA Food and Drug Administration Healthcare Provider Recruitment 52

European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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MAY 10, 2023

Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape Town, South Africa. ” Pediatric medical innovation remains a challenge.

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FDA Food and Drug Administration Recruitment Medical 52

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 is entering an initial release in April with full availability in June 2023. restor3d, a research-driven medical device company, announced that the U.S.

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FDA Patients Food and Drug Administration Recruitment 52

European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Globalisation and supply chain complexity are a factor.

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Legacy MEDSearch

FEBRUARY 3, 2023

a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating room setting. Food and Drug Administration (FDA).

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Legacy MEDSearch

SEPTEMBER 6, 2022

Food & Drug Administration (FDA) for the SAINT TM Neuromodulation System for the treatment of major depressive disorder (MDD) in adults who have failed to achieve satisfactory improvement from prior antidepressant medications in the current episode. Magnus Medical, Inc. , George, M.D., Magnus Medical, Inc. ,

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Medical FDA Food and Drug Administration Recruitment 52

European Pharmaceutical Review

JUNE 27, 2023

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023.

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Legacy MEDSearch

OCTOBER 13, 2022

Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. market launch planned for early 2023. See Full Press Release at the Source: Nevro Announces FDA Approval of HFX iQ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain. Are you hiring?

FDA 52

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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. “Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM Infusion System as compared to vials.

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.

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Food and Drug Administration Manufacturing Engineering Pharmacology 76

Legacy MEDSearch

OCTOBER 18, 2023

Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. In fact, the Amputation Reduction and Compassion (ARC) Act, introduced in Congress in June 2023, seeks to reduce the high rates of amputation in the U.S. Cardio Flow, Inc. , Announces U.S.

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Food and Drug Administration Food FDA Physicians 52

PM360

OCTOBER 25, 2023

Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. 1 Between 2022 and 2023, 47% of Phase III oncology trials involved combination therapies, a number that continues to grow over time (see Figure 1). JAMA Network Open 5 , no. References: 1. 3 (2022): e222265.

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Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

Nixon Gwilt Law

SEPTEMBER 7, 2023

Some restrict or prohibit certain disclosures of drug and alcohol treatment records for minors, for example. While VR holds significant promise, the long-term effects on pediatric populations are not yet fully understood and it can be hard to quantify long-term benefits or risks to the FDA.

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Food and Drug Administration Education Insurance Healthcare 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.

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Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Legacy MEDSearch

SEPTEMBER 20, 2023

Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue Imaging System. SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced U.S.

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Food and Drug Administration Recruitment Physicians Patients 52

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FEBRUARY 16, 2023

The company will showcase the new 7.5mm intramedullary device, of which over two dozen have already been implanted in patients, at the American Academy of Orthopedic Surgeons (AAOS) 2023 Annual Meeting in Las Vegas, March 7-11 (booth 1223). Food & Drug Administration (FDA).

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Legacy MEDSearch

JUNE 16, 2023

Food and Drug Administration. According to Pierce Nunley, orthopedic spine surgeon at Specialists Hospital of Shreveport, Shreveport, Louisiana, “In 25 years of research this was the only FDA study I have ever been in where I got to choose intraoperatively between two different study devices.

Food and Drug Administration 52

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Legacy MEDSearch

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. Press Release by: Inspira Technologies.

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Pharmaceutical Technology

JUNE 5, 2023

The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023. The company’s commercial strategy for the therapy includes an extensive patient support programme named RYZUP, which supports and educates those for whom the drug is prescribed and assists with access to the medicine.

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Legacy MEDSearch

JANUARY 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the Flex-Thread Ulna Intramedullary (IM) Nail System. Expected to launch in February 2023, the Flex-Thread Ulna IM Nail is intended for use in the fixation of fractures and osteotomies of the ulna.

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Food and Drug Administration FDA Recruitment Medical 97

Nixon Gwilt Law

DECEMBER 16, 2021

We also speak, network, and learn at various conferences throughout the year. Rounding it all out is our podcast on the Slice of Healthcare network called Decoding Healthcare Innovation. So much so that we’ve recently welcomed 20-year Food and Drug Law veteran and FDA expert Mark Mansour, Esq., Don’t wait!

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Legacy MEDSearch

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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Legacy MEDSearch

AUGUST 3, 2023

Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use hemodialysis device, for two modalities of continuous renal replacement therapy (CRRT): continuous venovenous hemodialysis (CVVHD) and slow continuous ultrafiltration (SCUF).

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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 confident that they will be a great partner for us as we bring our treatment for Parkinson’s disease to the clinic in 2023.”.

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FEBRUARY 10, 2023

Food and Drug Administration (FDA) to market its fully convertible stemmed total shoulder arthroplasty system with an ellipsoid anatomic head. release in the second quarter of 2023 followed by a larger commercial launch later in 2023. Catalyst OrthoScience Inc. Catalyst expects to begin the limited U.S.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

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. ” This latest FDA clearance for the EyeArt v2.2.0

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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. The research also identified other challenges for mRNA therapeutics’ delivery , including their high cost, susceptibility to degradation by ribonucleases and limitations with drug delivery systems.

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Food and Drug Administration Medicine Safety Consulting 90

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau. 2023 AD/PD Conference.

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Legacy MEDSearch

APRIL 26, 2023

Food and Drug Administration (FDA). Pulse’s FDA clearance means the company’s SphygmoCor technology can now be expanded to be used in decentralized clinical trials, remote patient monitoring, and for self-monitoring at home. Are you hiring?

FDA 52

FDA Food and Drug Administration Management Recruitment 52

Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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