MedCity News

APRIL 17, 2024

The devices are not currently being removed from the market. The post FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries appeared first on MedCity News. The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp.,

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World of DTC Marketing

JUNE 2, 2021

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. Here are some basics: 1ne: Physicians receive a lot of emails and don’t have time to read every one. 100 percent of U.S.

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Legacy MEDSearch

APRIL 6, 2023

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. Icentia Inc., “This approval marks a key milestone for our company.

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World of DTC Marketing

MARCH 23, 2022

Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. Of course, they should, but in the end, it’s going to come down to trust in their doctor and the FDA. Do patients care? Do patients care?

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Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. We expect this important innovation to be commercially available in the US market by the end of June 2023.”

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MedCity News

MARCH 16, 2023

Physicians face a lot of barriers from insurers in completing studies on drugs in the accelerated approval pathway, declared Dr. Robert Califf, commissioner of food and drugs at the Food and Drug Administration. Insurers need to help, he said during the AHIP Medicare, Medicaid, Duals and Commercial Markets Forum.

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Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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Legacy MEDSearch

MAY 22, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The designation allows a collaborative and streamlined review pathway with FDA so the Orlucent technology can get to the market faster. Orlucent, Inc., president of Orlucent.

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World of DTC Marketing

MARCH 11, 2022

Trust, for example, in physicians is still relatively high. Most patients completely trusted their physicians “to put their needs above all other considerations” (69%). Physician trust in the U.S. Physician trust in the U.S. What does this mean for DTC and HCP marketing? But do doctors trust the system?

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Legacy MEDSearch

SEPTEMBER 12, 2022

a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. Aerin Medical Inc., Aerin Medical is a privately held, venture-backed company, with U.S.

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World of DTC Marketing

AUGUST 25, 2022

Pharma companies have access to some of the best physicians in the country, and they are underutilized when helping patients understand health issues. This also means you must have a content strategy based on listening to patients, nurses, and physicians. DTC marketers need to fight for the information their audience wants.

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LEVO Health

OCTOBER 26, 2022

The medical device market is more saturated than you might think. You need a marketing strategy that sets your medical device apart from the competition. Bringing Your Medical Device to the Market. The first step to understanding medical device marketing is to learn how the U.S. How the FDA Classifies Medical Devices.

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Legacy MEDSearch

OCTOBER 9, 2023

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.

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Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. The NiTy+ One-Shot is the first instrument of its kind in the bone-fixation device market to feature a uniquely designed, single-pass insertion instrument. About Tyber Medical LLC. Press Release by: Tyber Medical.

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Legacy MEDSearch

SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. The clearance allows the company to market and sell the device to more pharmaceutical companies, healthcare organizations, and academic institutions across the country, expanding access to a simple and virtually painless blood collection experience.

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Legacy MEDSearch

OCTOBER 18, 2023

Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. It also provides faster run times, consistent treatment outcomes, and a nearly flat learning curve for physicians, making it an ideal choice for today’s hospitals, ambulatory surgical centers, and office-based labs.

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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., “We are excited to receive 510(k) clearance for our VisAble.IO The BioTrace.IO

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Legacy MEDSearch

JULY 25, 2023

The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test. Are you hiring?

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pharmaphorum

JANUARY 20, 2023

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer’s disease therapy donanemab based on mid-stage clinical results, but says it remains on track to file a traditional submission around the middle of this year. Final results from CLARITY-AD are also due in the first half of this year.

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Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences ’ Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis in pre-menopausal women. The companies will co-market the therapy in the region and will be made available soon.

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World of DTC Marketing

JANUARY 1, 2022

1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. Some of the questions I get from senior marketing people leave me speechless. Here are things I believe are more realistic.

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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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Celeritas

OCTOBER 12, 2022

Due to rigid FDA regulations, however, pharma financial resources are often depleted in generating drugs which fail to pass the approval process. The Problem we Solve: Meetings between physicians and pharma representatives last, on average, less than 6 minutes. The post What are E-Detailers and how can they Benefit Pharma Marketers?

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Nixon Gwilt Law

JULY 15, 2022

to allow behavioral health services to be furnished by clinical staff under the general supervision of a physician or non-physician practitioner (“NPP”), so long as CMS’ “incident to” requirements and state licensure requirements are met.

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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. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

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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. The post FDA grants EUA for Sobi’s Covid-19 treatment appeared first on Pharmaceutical Technology.

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Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

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Legacy MEDSearch

MARCH 1, 2024

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.” Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Are you hiring?

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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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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. Measurement interpretation has been expanded to all physicians with appropriate training. ” Age has been removed as the first selection probe and exam-type step.

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MedCepts

NOVEMBER 7, 2017

Therefore, the first thing to consider when selling to physicians is that your product, device or service is safe. In addition, it needs to be approved either by the FDA or other respective authorizing body. Physicians Seek Evidence based information. When selling to physicians, yours answers should preferably be evidence based.

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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. FemDx Medsystems, Inc.,

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Legacy MEDSearch

JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The novel Reverse HRS is now beginning enrollment in the FDA IDE clinical trial with multiple outcome measures being evaluated.” Press Release by: Hip Innovation Technology.

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Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). Ipsen is also seeking marketing approval from the European Medicines Agency, with a final decision expected in the second half of 2023.

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Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. There are only two marketed treatments for ALS in the US. The FDA’s action plan.

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Legacy MEDSearch

DECEMBER 21, 2022

Food and Drug Administration (FDA) for 510(k) clearance. If FDA clearance is obtained, the ALICE device production line will be extended for Low-Rate Initial Production (LWRIP), which is an important operational stage in developing infrastructure to support serial manufacturing, quality control and shipping. Are you hiring?

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Legacy MEDSearch

AUGUST 22, 2022

Food and Drug Administration (FDA) has granted 510(k) clearance to the MedWand,” shared MedWand CEO and Co-Founder, Robert Rose. “As MedWand Mobile Clinic – Designed for physician or home visits and remote patient monitoring applications. To request a demo today visit www.medwand.com. “I I am happy to share that the U.S.

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