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. physicians the opportunity to treat their patients with this novel device.”

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European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today? Prefilled syringes bring a range of benefits.

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European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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Legacy MEDSearch

DECEMBER 7, 2022

Medical device and technology company Lazurite has received recognition from Medical Device Network Excellence Awards & Rankings, one of the largest, most prestigious, and widely recognized programs in the industry. All Commended companies will be entered into the Medical Device Network Awards at the end of the year.

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Networking Medical Food and Drug Administration Recruitment 98

Legacy MEDSearch

OCTOBER 30, 2023

Medinol today announced United States Food and Drug Administration (FDA) approval for the EluNIR-PERL drug-eluting stent (DES) for the treatment of coronary artery disease. EluNIR-PERL builds upon the proven performance and clinical data of the EluNIR DES system. “We are pleased to bring technologies to the U.S.

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Food and Drug Administration FDA Distribution Recruitment 52

Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.

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Food and Drug Administration Physicians Prescription Medical 111

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SEPTEMBER 18, 2023

a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that the U.S. to improve the usability of the system without compromising functionality or patient safety and are looking forward to its use in the study,” he continued. . CereVasc, Inc., Carl Heilman, M.D.,

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Food and Drug Administration FDA Patients Recruitment 52

Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration).

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Food and Drug Administration Patients Safety Recruitment 52

Legacy MEDSearch

MARCH 27, 2023

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. The LCD screen on the handle of the device allows the physician to visualize internal patient anatomy in line with instrument insertion. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device.

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Food and Drug Administration FDA Recruitment Physicians 52

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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Food and Drug Administration Pharmacology Side effects Physicians 141

Pharmaceutical Technology

NOVEMBER 10, 2022

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Swedish Orphan Biovitrum AB ’s (Sobi) Kineret (anakinra) to treat Covid-19 in adult patients who are hospitalised with pneumonia. Additionally, the benefits offered by Kineret were found to last long.

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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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Pharmaceutical Technology

JANUARY 12, 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. Previously known as PT027, Airsupra is a pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication.

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Food and Drug Administration FDA Physicians Food 52

Legacy MEDSearch

NOVEMBER 14, 2022

Food and Drug Administration (FDA). IntraOpVSP displays patient CT and MRI as three-dimensional holograms in AR headsets, helping surgeons visualize surgical plans, anatomical targets, and cutting guides alongside or overlayed on the patient. Food and Drug Administration cleared the software for use in 2022.

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Legacy MEDSearch

JUNE 9, 2023

Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD).

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Legacy MEDSearch

OCTOBER 17, 2023

FloBio , a medical diagnostics company, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. DOACs can elevate bleeding risk and complicate emergency care.

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Food and Drug Administration Recruitment FDA Management 52

European Pharmaceutical Review

AUGUST 30, 2022

The European Commission has granted conditional marketing authorization to BioMarin’s ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe haemophilia A in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5).

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Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software.

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Pharmaceutical Technology

FEBRUARY 9, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat the retinopathy of prematurity (ROP) in preterm infants. A VEGF inhibitor, Eylea is jointly developed by Bayer and Regeneron Pharmaceuticals.

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Pharmaceutical Technology

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

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Food and Drug Administration FDA Physicians Food 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 “We are excited to receive 510(k) clearance for our VisAble.IO

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Legacy MEDSearch

MARCH 15, 2023

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 AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

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Food and Drug Administration FDA Recruitment Physicians 97

pharmaphorum

SEPTEMBER 29, 2022

In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Food and Drug Administration (FDA) regulation as a medical device. not a medical device, ii. a medical device subject to FDA oversight and enforcement.

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European Pharmaceutical Review

AUGUST 14, 2023

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study.

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Evolve Your Success

MAY 17, 2022

In part two of our interview with Antra Boyd and Karen DiMarco, we get more of their perspective of the medical sales industry, specifically the role they believe a medical sales rep plays and its importance to their role as nurses. To listen to the first part, check it out at The Medical Sales Podcast. Sales can be pushy.

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Medical sales Medical Sales Patients 52

Legacy MEDSearch

MARCH 22, 2023

Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan® , the non-invasive liver management technology by Echosens. The patient population has been expanded from “patients with liver disease” to “patients with confirmed or suspected liver disease.”

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Management FDA Food and Drug Administration Physicians 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. About Orlucent Orlucent, Inc.

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Legacy MEDSearch

JANUARY 18, 2023

Cytovale ® , a medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced today that its IntelliSep ® test has received U.S. IntelliSep will be available in the United States in the coming weeks.

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Food and Drug Administration FDA Recruitment Physicians 98

Pharmaceutical Representative Training

DECEMBER 28, 2021

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines.

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Legacy MEDSearch

AUGUST 29, 2022

a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced that the U.S. “Reports in the literature document that chronic hydrocephalus occurs in 9% to 48% of patients with paSAH. CereVasc, Inc., About CereVasc, Inc.

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FDA Food and Drug Administration Recruitment Physicians 52

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.

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Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

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Patients Food and Drug Administration Marketing Pharma 52

Legacy MEDSearch

APRIL 27, 2023

(Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced that it received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA).

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FDA Food and Drug Administration Recruitment Medical 52

Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. This type of advertising is often used to raise awareness of a new drug or to promote a new indication for an existing drug.

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Healthcare Healthcare Marketing Pharma 40

Legacy MEDSearch

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. was achieved indicating that physicians can precisely target and destroy liver tissue and unresectable liver tumors.

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Legacy MEDSearch

AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. It is the next generation of highly crosslinked polyethylene with vitamin E antioxidant that is intended to further our primary goal of providing immense benefits to our patients.”

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Food and Drug Administration FDA Recruitment Marketing 52

Legacy MEDSearch

JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of its Zoom RDL Radial Access System, the company’s latest innovation in elevating stroke care and the first radial access platform developed specifically for ischemic stroke treatment. Imperative Care, Inc., announced U.S. Justin Singer, M.D., The Zoom RDL provided.088”

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