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The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.
The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities. Combined, DTx and DCTs improve patient recruitment, retention, and access, allowing researchers to pull from underserved communities, including rural populations.
The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. In addition, Ayvakit is the only treatment approved across the spectrum of indolent and advanced systemic mastocytosis.
IN SUMMARY: American healthcare is failing. Not only has the FDA become a political pawn but almost half the population is now obese. While there are lots of reasons for this the silence of healthcareproviders is a huge reason. We need to do to obesity what we did for smoking.
Understanding Your Audience: Different audiencespatients, healthcare professionals, or payersrequire tailored messages. For instance, while patients prioritize benefits and side effects, healthcareproviders look for clinical evidence and efficacy. How can you ensure your strategy stands out?
As we approach 2025, emerging trends are reshaping how the industry engages with patients and healthcareproviders. With advancements in technology, increasing competition, and changing patient expectations, pharma marketers need to stay ahead of the curve. Patient-Centric Marketing Patients want to feel heard.
These networksspanning healthcare professionals, patients, and digital platformsare the lifeblood of modern pharma marketing. In the pharmaceutical industry, these networks often include healthcareproviders, patient groups, digital channels, and key opinion leaders (KOLs). What Are Marketing Networks?
In a highly regulated industry, choosing the right keywords can determine whether your ads reach healthcare professionals, patients, or caregivers effectively. Understanding how patients and healthcare professionals search for medical information is key. Pharmaceutical marketers face a unique challenge.
There isn’t one method to get people exercising; it will take an approach for every healthcareprovider to communicate the importance of exercise. Pharma websites provide the prescription that can help people overcome health problems but too often, they ignore the patient’s responsibility to lose weight and exercise.
Medical device app development takes front stage today in changing the way healthcare is delivered. From enabling remote patient monitoring to enhancing device usability, these mobile apps smoothly interact with medical devices to give patients and healthcare practitioners a more connected, data-driven method of managing health.
Pfizer is still waiting for the green light to complete an acquisition of digital health company ResApp, a deal that looks even better now that its smartphone app for people with obstructive sleep apnoea (OSA) has been approved by the FDA. The post ResApp bags FDA okay for sleep apnoea app, after Pfizer takeover bid appeared first on.
Are you targeting healthcareproviders (HCPs), patients, or payers? Craft a Patient-Centric Approach Todays consumers want more than medication; they want solutions. For instance, campaigns for branded drugs like Lipitor and Jardiance have gained traction by focusing on patients real-life experiences.
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.
The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk. Simultaneously, the companies have signed a securities purchase agreement under which Sanofi will procure $35m of Provention’s common stock on teplizumab, obtaining FDA approval. .
The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. NeuroLogica Corp., Are you hiring?
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. million people in the UK and 2.7
Companies in 3D medical animation such as Infuse Med are adept in converting complicated medical jargon into understandable images appealing to patients, doctors, and other stakeholders. Check out some case studies where 3D medical animation simplified communication between healthcare professionals and their patients.
Patients with fibromyalgia – a common condition causing chronic pain, fatigue, poor sleep, and cognitive dysfunction – could get relief from a digital therapeutic (DTx) based on cognitive behavioural therapy, according to a clinical trial. It is available on prescription from healthcareproviders.
In todays competitive market, where digital strategies and patient-centric approaches are essential, having an expert partner is more critical than ever. A pharmaceutical marketing company does more than run adsit builds connections between your brand, healthcareproviders (HCPs), and patients.
The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). Further findings from the Phase III trial The FDA approval is based on results from the Phase III STELLAR trial.
The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Asthma control improvement and safety profile were consistent with previous clinical trials.
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. And, if there are concerns, the pharmacist can call their healthcareprovider to develop a plan.
Regulatory shifts, changing consumer demographics, cutting-edge research, landmark policies like the Patient Protection and Affordable Care Act, and the push towards outcomes-based reimbursement have raised the stakes for healthcare organizations. Technology has elevated the expectations of modern healthcare consumers.
However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.
Axial3D, a leader in medical segmentation and 3D solutions, today announced that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications.
US startup Dr B – formed in 2021 to help match patients seeking a COVID-19 vaccine to suppliers with leftover stock – is branching out into antivirals with the help of an $8 million fundraising. The “visitless prescription” service will be available for free for people with low incomes, according to Dr B’s website.
Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. per eligible Medicare patient case.
Otsuka America Pharmaceutical and Lundbeck have received approval from the US Food and Drug Administration (FDA) for a new drug application for Abilify Asimtufii (aripiprazole) to treat schizophrenia or for maintenance monotherapy treatment of bipolar I disorder in adult patients.
AI supports marketers in key areas such as personalized campaigns (with tailored messages to healthcare professionals (HCPs) and patients), predictive analytics, and social sentiment analysis. Respondents cite workflow automation, data analysis, and realtime content generation as areas of interest within their organizations.
In pharma marketing, targeting the right patients and providers ensures that every dollar spent delivers value, engagement, and, most importantly, trust. Patients: The End Consumers Patients are at the heart of pharma marketing. Patients: Highlight lifestyle benefits, such as convenience or improved quality of life.
AccurKardia , a medical technology company delivering clinical-grade ECG interpretation software, announced today that its flagship product, the AccurECG Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance. It is indicated for adults aged 22 and older.
This fuels an enormous need for effective patient communication and education as new therapies move through the biopharma pipeline. Marketing to rare disease patient populations is equal parts opportunity and responsibility. audiences (direct-to-patient advertising rules are fundamentally different overseas).
Join us as we welcome Justin Ramsaran, the dynamic VP of Digital Health at Fukuda Denshi America and CEO of R Group, who is shaping the future of healthcare with his expertise in remote patient monitoring and cardiac care innovation.
The clock has started ticking on the FDA’s review of Sanofi and AstraZeneca’s one-shot antibody to protect newborns and infants from respiratory syncytial virus (RSV), with a decision due in the third quarter – just in time for the 2023/24 RSV season.
Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcareproviders have more timely access to these medical devices. Ancora Heart , Inc., An estimated 6.5 million U.S. An estimated 6.5
DTx as a Pathway to Patient-Centered Care Though DTx is still largely in its “promise and potential” phase — especially when it comes to new innovations in mental health care — DTx technology offers a key opportunity for a more personalized, patient-centered approach to care.
Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.
HCPs need pharma, and pharma needs HCPs—so let’s make sure that this next chapter of engagement is one of partnership, in pursuit of the interest of patients.” Pharma marketers can look into these concerns to better tailor digital content and platforms to provide HCPs with what they need to make unbiased and informed decisions.
On 18 May 2023, the FDA announced the approval of Rinvoq (upadacitinib), AbbVie’s Janus kinase inhibitor (JAKi), to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) blockers.
In its 510(k) application to the FDA iHealthScreen has proposed the following indication for iPredict’s use: iPredict-AMD is indicated for use by health care providers to automatically detect more than early age-related macular degeneration (mteAMD) in adults above 50 years of age who have not been previously diagnosed with Late AMD (i.e.,
DTx as a Pathway to Patient-Centered Care Though DTx is still largely in its “promise and potential” phase — especially when it comes to new innovations in mental health care — DTx technology offers a key opportunity for a more personalized, patient-centered approach to care.
AstraZeneca has announced that its Tezspire (tezepelumab) received approv al from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the EU for self-administration in severe asthma patients aged 12 years and above.
Sales representatives play a crucial role in connecting healthcare facilities with innovative technologies that improve patient care. Clinical Knowledge: Possessing a basic understanding of relevant medical conditions and procedures related to your devices will enhance your interactions with healthcareproviders.
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