Legacy MEDSearch

JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. The FREEDOM Infusion System currently includes the FREEDOM60 ® and FreedomEdge ® Syringe Infusion Drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

Legacy MEDSearch

JUNE 16, 2023

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

Food and Drug Administration 52

Food and Drug Administration Recruitment Safety Medical 52

Legacy MEDSearch

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

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. I’m excited that the study met its superiority composite endpoint, which included effectiveness and safety components. and projected to impact 70 million Americans by 2040.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

Pharmaceutical Technology

JUNE 15, 2023

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Food and Drug Administration approval. Pharma companies need tools like AI that can reliably improve this percentage without jeopardizing safety.

Food and Drug Administration 52

Food and Drug Administration Side effects Recruitment Safety 52

Legacy MEDSearch

MARCH 21, 2023

Food and Drug Administration (FDA). The safety and efficacy of the Lumicell DVS in detecting residual cancer left behind by standard of care surgical procedures has been evaluated in two studies: INSITE and a feasibility study of 234 patients at 16 sites, results of which were published in JAMA Surgery. Lumicell, Inc.,

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Medical 52

Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. Food and Drug Administration. Ancora Heart , Inc., a company developing a novel device-based therapy to address heart failure, announced that the U.S. ClinicalTrials.gov Identifier: NCT04331769 ).

Food and Drug Administration 52

Food and Drug Administration FDA Medical Recruitment 52

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. However, we observed dose-dependent colonisation across Phase I studies and in Phase II.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Medicine Pharma 98

Nixon Gwilt Law

SEPTEMBER 7, 2023

A long and expensive path to market The Food & Drug Administration (“FDA”) clearance process for new medical devices for adults, including Software as a Medical Device (“SaMD”) , already requires extensive time and resources to prove to the FDA that the device in question is safe and effective for patients.

Food and Drug Administration 52

Food and Drug Administration Education Insurance Healthcare 52

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. Secondary endpoints will include response rate, overall survival, pharmacokinetics, safety and tolerability. Benefits of daily oral chemotherapy over IV. Oncotarget.

Patients 84

Patients Food and Drug Administration Side effects Safety 84

Legacy MEDSearch

JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. Age-related macular degeneration (AMD) is a leading cause of permanent vision loss for people age 50 and older, and the number one cause of blindness in people age 65 years and older.

Food and Drug Administration 52

Food and Drug Administration Recruitment FDA Patients 52

European Pharmaceutical Review

MARCH 1, 2023

The honeycomb-like pore structure, which can be seen in elegant cakes, fades into an irregular network with rod-like structures, which are partially collapsed and have drop-shaped ends. As a result, rejected product vials can be reduced and the safety of the application is guaranteed. J Food Science 2005; 70(7): e437-e442 [[link] 5.

Distribution 83

Distribution Electronics Pharmaceutical Food 83

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. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

Food and Drug Administration 98

Food and Drug Administration Food Networking Safety 98

Legacy MEDSearch

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

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 78

Food and Drug Administration Safety Patients Leads 78

European Pharmaceutical Review

FEBRUARY 14, 2023

Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”

Food and Drug Administration 91

Food and Drug Administration Medicine Safety Consulting 91

Pharmaceutical Technology

JANUARY 10, 2023

The international T1D network TrialNet’s research was instrumental in the FDA’s approval of the first drug to delay T1D in at-risk people. The TOPPLE Study , for example, is testing the safety of a plasmid therapy being developed by Novo Nordisk in adults diagnosed with T1D in the past 48 months.

Patients 98

Patients FDA Medicine Education 98

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The safety and efficacy of mRNA vaccines should be a game changer and is the likely solution to antibiotic-resistant microorganisms and emerging viral pathogens.”

Pharmaceutical 126

Pharmaceutical Food and Drug Administration Manufacturing FDA 126

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

Celeritas

DECEMBER 30, 2022

The procedure of on-site generation of hydrogen using steam methane reforming involves: livestock manure, food waste, and crop residue is collected for centralized recycling, mixture, and ultrasonic treatment. A study by the National Institute of Renewable Energy in 2013 discovered the cost of a digester for food waste was USD 561.00

Engineering 52

Engineering Distribution Transportation Safety 52

Legacy MEDSearch

SEPTEMBER 11, 2023

Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. ” About Zeta Surgical Zeta Surgical is a digital surgery company focused on improving the accuracy, safety, and accessibility of image guided procedures. To learn more, visit: www.zetasurgical.com.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52