Pharmaceutical Technology

MAY 16, 2023

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

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Legacy MEDSearch

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., and Adel Malek, M.D.,

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PM360

FEBRUARY 12, 2024

Created by The European Organization for Rare Diseases (EURORDIS) , this globally coordinated event brings together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers, and their families.

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. appeared first on Pharma Marketing Network.

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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.

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Legacy MEDSearch

NOVEMBER 14, 2022

Xironetic, an early-stage healthcare technology company, today announced its IntraOpVSP augmented reality (AR) visualization software for complex surgeries has received clearance from the U.S. Food and Drug Administration (FDA). Food and Drug Administration cleared the software for use in 2022.

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Legacy MEDSearch

OCTOBER 24, 2023

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. “Our unique stenting technology is designed to simplify procedures, improve patient outcomes, and reduce angioplasty times, marking a significant advancement in coronary treatments.”

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FDA Food and Drug Administration Recruitment Food 52

Legacy MEDSearch

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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FDA Patients Food and Drug Administration Recruitment 52

Clarivate

SEPTEMBER 26, 2023

One of the critical factors determining the success of a clinical trial is the selection of appropriate clinical sites that have evidenced access to specific patient populations. Patient recruitment accounts for 32% of all trial costs and patient drop out averages 18%, according to Deloitte figures. Food and Drug Administration.

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Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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European Pharmaceutical Review

JANUARY 19, 2023

The contribution will enable the programme to reach additional physicians and medical students, further expanding the initiative that aims to extend the reach of clinical trials in underserved patient populations in US communities. The Winn Award Program has so far trained 114 early-stage investigator physicians.

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Pharma Marketing Network

MAY 11, 2023

However, recent advancements in research have resulted in new drugs that show promising results in slowing the progression of the disease. One of the most notable breakthroughs in Alzheimer’s treatment is the approval of Aduhelm, a new drug developed by Biogen, by the U.S. Food and Drug Administration (FDA) in June 2021.

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Legacy MEDSearch

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., The Lumicell DVS is not commercially available.

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Food and Drug Administration FDA Recruitment Medical 52

Legacy MEDSearch

MARCH 15, 2023

LIVMOR’s technology was commercially deployed within the VA Healthcare System in Dallas, Texas. In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. HeartBeam CEO and Founder.

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Food and Drug Administration FDA Recruitment Physicians 97

Legacy MEDSearch

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. the healthcare subsidiary of Samsung Electronics Co., the healthcare subsidiary of Samsung Electronics Co., About NeuroLogica.

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Legacy MEDSearch

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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Legacy MEDSearch

OCTOBER 17, 2023

Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. FloBio’s test determines blood clotting status and whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs).

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Legacy MEDSearch

MARCH 16, 2023

The DeltaScan Brain State Monitor provides a quick and objective measurement of acute brain failure even before symptoms appear, enabling clinicians to provide immediate treatment and help patients regain cognitive well-being. It’s clear from the evidence that minimizing the duration of acute brain failure can improve outcomes.”

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FDA Food and Drug Administration Patients Recruitment 52

Legacy MEDSearch

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. Otsuka Medical Devices Co.,

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Medical Food and Drug Administration FDA Recruitment 52

Legacy MEDSearch

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).

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European Pharmaceutical Review

SEPTEMBER 2, 2022

An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). How is the efficacy of RMMs assessed? These guidelines have been updated recently.

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Food and Drug Administration Medicine Safety Food 70

Legacy MEDSearch

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). per eligible Medicare patient case. ClarityPro is now the only FDA-indicated device for the diagnosis of ESE in adult patients over the age of 18. Ceribell, Inc. NTAP reimbursement of up to $913.90

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FDA Food and Drug Administration Healthcare Provider Recruitment 52

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. This allows for a cyber?

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Legacy MEDSearch

JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. Early detection of sepsis is an invaluable capability for healthcare professionals.

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Nixon Gwilt Law

DECEMBER 16, 2021

What can Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022? We asked our team five direct questions about innovations in healthcare, life sciences, and digital health in the coming year: What healthcare trends or opportunities are you most excited about?

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Legacy MEDSearch

MARCH 29, 2023

a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. It is indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding. Advamedica Inc.,

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Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

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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.

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Legacy MEDSearch

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. 3 Based on an investigational clinical study conducted by Paige involving 3 pathologists and data from 148 patients. Klimstra, M.D.,

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FDA Food and Drug Administration Recruitment Management 52

Legacy MEDSearch

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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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. .

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Legacy MEDSearch

AUGUST 29, 2022

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt ® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). . Located in Massachusetts’ healthcare hub, CereVasc, Inc.,

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FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc.

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FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Ancora Heart , Inc., An estimated 6.5 million U.S. An estimated 6.5

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Food and Drug Administration FDA Medical Recruitment 52

Legacy MEDSearch

MAY 22, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. president of Orlucent.

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FDA Food and Drug Administration Physicians Recruitment 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

However, as with any emerging area of healthcare innovation, new legal and regulatory considerations arise that must be thoughtfully addressed. Some restrict or prohibit certain disclosures of drug and alcohol treatment records for minors, for example. does not currently have centralized insurance coverage for pediatric healthcare.

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Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). The InTandem name reflects both the synchronization inherent in the device’s mechanism of action and the partnership formed between patient and device. The burden on patient functioning is also profound. MedRhythms also unveiled the brand name for MR-001: InTandem.

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