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.

Food and Drug Administration 97

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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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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

MARCH 1, 2024

Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. Initial findings from AGENT IDE, presented by interventional cardiologist Robert W. Are you hiring?

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Food and Drug Administration FDA Recruitment Physicians 52

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 97

European Pharmaceutical Review

APRIL 21, 2023

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs.

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Pharma Food and Drug Administration Medicine Pharmaceutical 98

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. Lythgoe, and Vinay Prasad.

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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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European Pharmaceutical Review

DECEMBER 30, 2024

A 2023 report by the Alliance for Regenerative Medicine identified skills gaps in analytical development and testing, quality control, and manufacturing of cell and gene therapies 3 a gap which is expected to widen in the coming years. 2023; 29:SP4278. 2023; 30 761773. UK Cell and Gene Therapy Skills Demand Report 2023.

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Legacy MEDSearch

MARCH 7, 2023

Food and Drug Administration (FDA). X-Bolt is actively seeking distribution partners and preparing its commercial launch ahead of the Orthopaedic Trauma Association (OTA) meeting in October 2023. Pro-X1 will be X-Bolt’s flagship launch in the United States.

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

Specialization 52

Specialization FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

APRIL 27, 2023

Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). Data supporting the breakthrough device designation will be presented at the 24th Annual Meeting for The American Society of Breast Surgeons in Boston, MA on April 26-30, 2023.

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

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.

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FDA Food and Drug Administration Recruitment Medical 52

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

Legacy MEDSearch

JUNE 13, 2023

CorNeat Vision’s EverPatch , a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). in Q3 2023, expanding nationwide later in the year. The CorNeat EverPatch is the first synthetic, non-degradable tissue-integrating matrix for use in ophthalmic surgeries.

FDA 52

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.

Patients 52

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Legacy MEDSearch

JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

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FDA Food and Drug Administration Recruitment Medical 52

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

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).

FDA 52

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Legacy MEDSearch

FEBRUARY 3, 2023

The advantages of rebreathing anesthesia have made this method the standard of care for anesthesia administration in the OR setting. VERO Biotech is currently in the process of conducting similar validations and expect to have the data available Q1-2023. Food and Drug Administration (FDA).

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FDA Food and Drug Administration Recruitment Patients 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. J National Comprehensive Cancer Network. To advance equity in clinical research, the U.S. 2019;17(11):1309-1316.

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Legacy MEDSearch

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). including 108,000 geriatric fractures.

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Food and Drug Administration Patients Recruitment Medical 52

Legacy MEDSearch

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). for eligible Medicare patient cases will become available on October 1, 2023. Ceribell, Inc. ® announced that its new software ClarityPro has received 510(k) clearance from the U.S. ” said Jane Chao, Ph.D.

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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. . Demonstrations will be available at booth #527. About Eyenuk, Inc.

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Legacy MEDSearch

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. . We know that going wireless will have the greatest impact for our littlest patients.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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. Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns from patients. We believe HFX iQ represents the future of SCS therapy.” In addition to the U.S.

FDA 52

FDA Food and Drug Administration Recruitment Patients 52

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. ,

Medical 52

Medical FDA Food and Drug Administration Recruitment 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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Legacy MEDSearch

JUNE 16, 2023

Food and Drug Administration. “The continued adoption of this cervical total disc replacement technology at one-level propelled Centinel Spine to record revenues and a top market position in the first quarter of 2023. The study includes 431 Subjects at 29 sites throughout the U.S. and with oversight from the U.S.

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Food and Drug Administration Recruitment Medical Safety 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

Some restrict or prohibit certain disclosures of drug and alcohol treatment records for minors, for example. For example, according to the 2023 Texas Medicaid Telecommunications Services Handbook, Texas Medicaid covers “telemonitoring” (a.k.a. The Family Educational Rights and Privacy Act (“FERPA”), is a U.S.

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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., Are you ready for 2022?

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

Legacy MEDSearch

AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. The first products for Activit-E will launch in the beginning of Q3 2023 for select U.S. Global expansion will begin in 2024.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

Legacy MEDSearch

APRIL 26, 2023

Food and Drug Administration (FDA). The CONNEQT products, to begin launching in 2023, will incorporate the same FDA-cleared and patented SphygmoCor® arterial health technology that has been used in medical devices for more than 20 years by CardieX subsidiary, ATCOR.

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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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