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As medical devices evolve and become more sophisticated, we are seeing a trend toward specialization. Building customized solutions for specialized disease states creates a nimbleness to respond to new conditions and develop a platform uniquely suited for that condition. It will become commonplace to see devices that break new ground.
To bring cross-agency clinical leaders together, the FDA should establish a Center of Excellence for Rare Diseases. This would bring together specialized staff and resources from multiple review divisions to leverage their expertise about different bodily systems, trial designs, pharmacology, and other specialized fields.
The reality is that physicians, patients, and caregivers are active on platforms like LinkedIn, Twitter (X), Instagram, and even TikTok. First, establish social media SOPs (standard operating procedures) aligned with FDA, EMA, and FTC guidelines. Without it, brands risk warning letters or reputational damage.
Marketers can run sponsored content, InMail campaigns, and text ads to engage physicians, pharmacists, and healthcare executives. Best For: Targeting verified HCPs in a compliant and specialized environment. Follow FDA and Regulatory Guidelines Ensure all PPC ads adhere to FDA, EMA, or MHRA regulations.
Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.
a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., Chief Executive Officer of SpectraWAVE.
The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis.
2 and over a million actively licensed physicians 3 are available to prescribe them? Pharma companies have shifted their focus to specialized conditions such as multiple sclerosis and ulcerative colitis. Of the 50 new drugs approved by the FDA in 2021, a majority treated conditions affecting small patient populations.
This was followed by additional partnerships with Hospital for Special Surgery (HSS) in New York, University Hospitals of Cleveland, and LG Electronics USA.”. “We Lazurite designs medtech devices, and its ArthroFree System is the first wireless camera with FDA clearance for arthroscopy and general endoscopy. About Lazurite.
CMI’s data reveals 61% of physicians from a range of specialities have a somewhat or very favorable view of pharmaceutical companies. An equal number of physicians feel that it helps patients learn about treatments and that branding messages are too broad and may confuse patients.
Members of a multidisciplinary care team may include physicians, nurses, pharmacists, radiologists, dieticians…the list goes on. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. But one key member is often omitted: the patient’s caregiver. What Can Pharma Do? REFERENCES: Gilda’s Club.
The perfect blend of persistent dedication, a heartwarming touch of southern hospitality, and an innate understanding of the needs of both physicians and patients. They lacked those people because we know a lot about the technology and how to interact with physicians so they bring us over. We assist with training the physicians.
With Edouard Saget In this episode, we have another special guest. What makes Edouard special? It’s trying to do all the processing of the physician in their brain as how they would want to do it and telling a digital or software robot to do it on their behalf, and it works. — Listen to the podcast here Will A.I.
In recent years, with the advent of biologics and novel therapeutic targets such as anti-TNF, anti-interleukin, and anti-integrin, there has been a steady increase in the number of agents approved to treat inflammatory bowel diseases (IBD), which has provided physicians with an increasing number of options to treat Crohn’s disease (CD).
Food & Drug Administration (FDA) classifies medical devices. How the FDA Classifies Medical Devices. The FDA classifies medical devices into one of three classes based on their risks and regulatory controls: . They are not obligated to submit data or information to the FDA. . FDA Premarket Requirements .
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Special software that takes DICOM images from CT scanners and creates a treatment plan, defines the distribution of the Alpha DaRT sources within the tumor. The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S. In the first study there was a 78% complete response (no residual cancer).
As per the US Department of Justice, Biogen paid remuneration in the form of training and consulting fees and speaker honoraria, to induce physicians to prescribe the company’s drugs, in violation of the Anti-Kickback Statute. 4 integrins, which play a key role in MS pathology.
A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market.
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In this episode, Samuel Adeyinka interviews Pat Kothe , founder of a company specializing in medical devices for healing abscesses. He went on to be a founder of a company that specializes in a device that helps with the healing of abscesses but I’m not going to say anymore. My partner is an emergency medicine physician.
Compliance-Ready Ad Strategies Pharma PPC campaigns must comply with FDA, HIPAA, and Googles healthcare advertising policies. Platforms like eHealthcare Solutions specialize in pharma-compliant digital advertising , ensuring that ads: Use pre-approved messaging for prescription drugs. Avoid misleading claims or improper targeting.
With Sean Pitts We have with us another special guest, and he goes by the name of Sean Pitts. I s there a specific field that you specialize in when it comes to the type of device that you’re supporting? They understand the American and European requirements of the FDA and the EU. Tune in now! If y ou ask, “W hat is OEM sales ?”
Healthcare Providers: Key Influencers Physicians, nurses, and pharmacists are the gatekeepers of medical advice and treatment recommendations. Specializations: A cardiologist may respond differently to marketing for a heart failure treatment than a general practitioner.
Founded in 1935 by Chiesi’s grandfather of the same name, Chiesi Group focuses on respiratory conditions, special care, and on rare diseases, including lysosomal storage disorders and rare haematological and ophthalmological diseases. “An These groups have also used patient feedback to build digital tools to help facilitate engagement.
The company has ramped up its patient access efforts through a partnership with the Chinese Red Cross Foundation, established in June 2021 and aimed at providing physician education and patient awareness programs for rare diseases. 3] Rare Diseases at FDA [online]. [4] Chinese Journal of Evidence-based Pediatrics. 2011; 6:81-82. [3]
Specialized Certifications Specialized certifications can demonstrate a medical sales representative’s expertise and commitment to the industry. This also requires medical sales representatives to be familiar with clinical data based on research and FDA regulations to ensure compliance.
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In this special episode for Breast Cancer Awareness Month, Veronica Vasek uncovers the challenges, triumphs, and the vital role that diagnostic sales reps play in the healthcare landscape. Veronica discusses a revolutionary technology for testing and how it’s transforming the way physicians and patients approach cancer treatment.
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.
So it’s very much a disruptive technology that is truly changing the paradigm of how physicians are treating prostate cancer which is really exciting. 09:24 – Jaclene Corstorphine (Guest) Yes, so with NanoKnife we are in the procedure with the physician and really highly involved in that procedure.
So it’s very much a disruptive technology that is truly changing the paradigm of how physicians are treating prostate cancer which is really exciting. 09:24 – Jaclene Corstorphine (Guest) Yes, so with NanoKnife we are in the procedure with the physician and really highly involved in that procedure.
After two years of pandemic fatigue, healthcare trust is at an all-time low, according to Edelman’s Trust Barometer Special Report on Trust in Healthcare. Trust, for example, in physicians is still relatively high. Physician trust in the U.S. Physician trust in the U.S. But do doctors trust the system?
I was at Physicians Online at the time. Yeah, I even wanted to wear the shirt to this FDA meeting. You know, in November 2009, the FDA held a public hearing about the promotion of Food and Drug Administrative Related Regulated Medical Products, using the internet and social media tools. You were PharmInfoNet.
Meet the guest: Greg Olson is a senior district service manager specializing in cardiac rhythm management, with over 25 years of experience in the medical sales industry. I’m your host, samuel, and today we have with us another special guest and he goes by the name of Greg Olson. Greg is in. He works for Medtronic, huge company.
And one physician told me that, asking a patient what his pain level is like asking the patient what his blood pressure level. And then we said, 'Let's go and start at the high end in operating rooms, ICUs or also physicians are used to getting the numbers and score indexes; and to treat based out solutions on that.
In the latest advancements of AI and med tech, the Eko DUO stands out as a smart and reliable product with FDA-cleared artificial intelligence (AI) algorithms being used to detect leading indicators of heart disease. The DUO can be used without the earpiece attachment altogether when paired with a mobile device.
This large sample size study gives physicians and patients alike the evidence-based confidence that the impact of Remote Electrical Neuromodulation (REN) with Nerivio is sustainable over a long time. We designed Nerivio with exactly these requirements in mind.”
But before the platform became widely available, patients could only be diagnosed after trained sonographers performed an ultrasound in a hospital or specialized setting – typically after the onset of symptoms. since it received FDA 510(k) clearance in 2020. For more information, visit captionhealth.com.
48:12 What is Uri Gorenseeing that is special in the Israeli Digital Health ecosystem? Basically, I started teaching myself how to get good information outside the internet and see how that empowers us with our discussion with a physician with everything that we did. I think vaccines, in most cases, is a special case.
So it’s very much a disruptive technology that is truly changing the paradigm of how physicians are treating prostate cancer which is really exciting. 09:24 – Jaclene Corstorphine (Guest) Yes, so with NanoKnife we are in the procedure with the physician and really highly involved in that procedure.
based physicians reveals that a majority are concerned and confused about what constitutes a life-threatening emergency that would make an abortion procedure legal in those 11 states where it has been banned. Doctor Docs: Doctors Left Concerned After Roe v. Wade Overturn. A recent Sermo study of 240 U.S.-based Or must it be 100%?”.
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