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Food and DrugAdministration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. CEO of Cardio Flow, stated: “Cardio Flow is committed to providing meaningful solutions that directly address the needs of physicians and their PAD patients through innovative product development.
Struggling with burnout while maintaining high-quality healthcare services that patients love? Tune in to our latest podcast as Lee Aase, founder of HELPCare, LLC, shares how he transitioned from his pioneering social media work at Mayo Clinic to lead an innovative membership-based direct-to-patient healthcare business.
On 6 July, in an effort to accelerate access, the US Food and DrugAdministration (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.
In June this year, it was announced that the US Food and DrugAdministration (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.
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.
Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .
Food and DrugAdministration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Healthcare systems and physicians will also be able to use the Tasso+ device with compatible collection tubes to make determinations on blood chemistries for their patients and expand care access. Tasso, Inc.,
Food and DrugAdministration. The adoption of the Early Bird system is a testimony to physicians embracing the benefits of early bleed detection for their patients and practice.”. “We The Early Bird was launched in 2019 following a De Novo classification by the U.S. About Saranas, Inc. Saranas, Inc.
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.
In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and DrugAdministration (FDA) requires a patient follow up period of at least 10-15 years.
The 2025 Medicare Physician Fee Schedule Proposed Rule (the “2025 Proposed Rule”) issued by the Centers for Medicare and Medicaid Services (or “CMS”) on July 10, 2024 contains a number of new policy proposals with significant implications for healthcare innovators. Stakeholders should consider submitting comments on this issue.
The Food and DrugAdministration (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. The post Why Is FDA Issuing Fewer Marketing Violation Letters?
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.
Food and DrugAdministration for its Respiratory Health point of care test. Visby Medical announced that it has received Emergency Use Authorization (EUA) from the U.S. However, PCR testing has not been widely adopted in outpatient settings in part, because of the expense required to adopt and maintain PCR instrumentation.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also since granted the Great Britain marketing authorisation of Lupkynis to treat adults with active LN. Notably, Lupkynis is the first oral therapy approved by the US Food and DrugAdministration (FDA) and EC for the treatment of active LN.
The order is contingent on the vaccine obtaining Emergency Use Authorization (EUA) from the US Food and DrugAdministration (FDA) as well as the Centers for Disease Control and Prevention (CDC) recommendation. million doses of the company’s Covid-19 vaccine, NVX-CoV2373, in the initial stage.
“To put this into perspective: if all of the patients were 100% adherent, then at most the brand would achieve 25% of the TRx volume that their sales team successfully had physicians write,” explains Josh Richardson, Chief Commercial Officer, Prescryptive Health. Eli Phillips, Jr.,
2 A study found that pharmaceuticals and other chemical products are responsible for 40 percent of the Dutch healthcare system’s greenhouse gas emissions and about 80 percent of its share of material extraction. The environmental impact of the Dutch healthcare sector beyond climate change: an input-output analysis. 2022; 6: 949-57.
Healthcare coverage is heterogeneous across emerging markets, with public funding limited by budgetary constraints. Indeed, in the US, the FDA has recently declined approval of Lilly’s sintilimab (Tyvyt), driven in part by a vote 14-1 against approval by the Oncologic Drugs Advisory Committee, owing to the availability of China-only data1.
On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.
Medinol today announced United States Food and DrugAdministration (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. For more information, see www.medinol.com.
In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.
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.
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 DrugAdministration (FDA). Food and DrugAdministration cleared the software for use in 2022.
Before 2020, the landscape of drug marketing involved following drug approvals by the Food and DrugAdministration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines. The technology identifies.
He discusses why the future of the healthcare industry in the United States lies not in hospital buildings but in surgery centers. I was working with the same physicians I used to sell stents to help them raise money and open their outpatient centers. We syndicate, which means we sell shares for physicians to invest.
Food and DrugAdministration (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. “It’s estimated that anywhere from 2% to 53% of U.S.
Food and DrugAdministration (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 MedWand Solutions, Inc.
Food and DrugAdministration (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.,
Food and DrugAdministration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Innovation in the baby care space matters because some of the largest issues facing caregivers and healthcare providers have yet to be solved.
The US Food and DrugAdministration 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. Dr. Itatani, MD, Ph.D.,
Food and DrugAdministration (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.,
Food and DrugAdministration (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.,
Food and DrugAdministration (“FDA”) for its XR90 augmented reality-based surgical visualization and navigation platform. We are just at the beginning of a journey seeing the clinical adoption of game-changing data and digital healthcare solutions.” MediView XR, Inc.,
Between 2015 and 2021, over a quarter of the drugs approved by the US Food and DrugAdministration (FDA) were associated with specific biomarkers. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules. That’s how money is saved and quality of life (QOL) is improved.
In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars. Senate Bill 562 (S.
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. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].
Food and DrugAdministration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers.
Food and DrugAdministration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). Endologix is wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy.
Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and DrugAdministration (FDA). I am a physician by training, and I worked in New York hospital emergency rooms for many years.
Food & DrugAdministration (FDA) classifies medical devices. Levo Health is a healthcare marketing agency that can help you optimize your marketing strategies. Working with physicians, medical practices, surgery centers, and hospitals all over the country, we can help you reach your ideal patient audience.
A strong medical sales team is essential for success in the healthcare industry. These teams not only drive product sales but also build lasting relationships with healthcare professionals, helping deliver innovative medical solutions to those who need them most. Network with healthcare professionals.
The CardioSTAT solution differentiates itself by being the most flexible solution available: physicians have a choice of multiple monitoring durations ranging from 24 hours to 14 days. The pay by duration model enables healthcare professionals to demonstrate cost savings while addressing a wide range of clinical needs. Are you hiring?
The findings don’t mention that those who fail to get vaccinations are putting healthcare workers and others at risk and that herd immunity may be impossible. Physicians have to be the first ones to break the resistance—the need to strongly urge patients to get vaccinated.
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