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Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and DrugAdministration on Biogen Inc.’s
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.
In this episode, Samuel Adeyinka interviews Marc Toth , who shares his entrepreneurial journey in the cardiovascular medical device sales industry. 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.
EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and DrugAdministration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.
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.
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 the world of medical device marketing and sales, executing a well thought through product launch provides a huge opportunity to gain market share, grow your clientele, and increase your revenue. Medical device products require approval by the Food and DrugAdministration (FDA) before they go to market.
a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and DrugAdministration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. Aerin Medical Inc., offices in California and Texas.
Food and DrugAdministration for its Respiratory Health point of care test. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs. About Visby Medical.
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. For more information, please visit www.saranas.com.
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.,
a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and DrugAdministration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., Chief Executive Officer of SpectraWAVE.
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 DrugAdministration (FDA) for marketing in the USA or other geographies.
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. Let Us Build You A Medical Sales Machine Today!
Food and DrugAdministration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO ® Vascular Occlusion System. Okami Medical Inc., Okami Medical – LOBO Vascular Occlusion System. ” About Okami Medical, Inc.
The Role of Certified Pharmaceutical Representatives in the Shifting Sales Landscape The US Bureau of Labor Statistics (BLS) projects the number of jobs for pharmaceutical sales representatives will grow by four percent by 2031, adding approximately 170,000 new job openings per year over this decade.
Food and DrugAdministration (FDA) for 510(k) clearance. Inspira plans for the ALICE to be the first device to Integrate the HYLA Blood Sensor designed to be non-invasive, perform continuous measurements and alert physicians at real time of sudden changes in a patient’s specific key blood indicators.
Food and DrugAdministration market clearance for the ArthroFree System. 2015), and has raised more than $25M from institutional investors, family offices, and more than 70 physician champions. The company hit an important milestone in March 2022 when it received U.S. Lazurite is located in Cleveland, OH (est.
Food and DrugAdministration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. According to Tyber Medical’s Senior Project Engineer Abe Perryman, physicians have responded favorably to the company’s new staple system.
The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and DrugAdministration (FDA). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.
Food and DrugAdministration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. For updates, follow Cytovale on LinkedIn and Twitter.
Food and DrugAdministration (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 DrugAdministration (FDA) 510(k) clearance for its FalloView device.
Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and DrugAdministration (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.” Are you hiring?
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. “We are pleased to bring technologies to the U.S.
This is a result of intensive research efforts that have produced regimens that have prolonged patient survival, most of which are a combination of a proteasome inhibitor + an immunomodulatory drug (ie. billion global sales expected by 2028, followed by Tecvayli with $2.6bn, which would mark a huge win for J&J in the MM space.
Food and DrugAdministration (FDA). Current and planned use cases for IntraOpVSP are expected to align to the needs of physicians across general, craniofacial and maxillofacial, neuro, orthopedic, plastic, thoracic and vascular surgery disciplines. 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.
The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. This can lead to significant losses for large companies.
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.,
Food and DrugAdministration (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.
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) clearance, allowing users to robotically insert and steer the XACT ACE® Robotic System remotely from the control room. Our clients include both blue-chip companies and innovative startups within the MedTech space.
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 DrugAdministration (FDA) for its VisAble.IO solution is not yet approved for sale or distribution in the USA and is limited by USA law to investigational use.
The US Food and DrugAdministration 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.
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). . CereVasc, Inc.,
a leading US developer of next gen endoscope systems announces today the US Food and DrugAdministration (FDA) has granted 510(k) clearance of its novel integrated 360° field of view colonoscope. Saneso Inc., “Our endoscopes are comfortably familiar in operation to traditional endoscopes.”
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.,
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. Please contact MedWand Sales to request a complimentary quotation.
Food and DrugAdministration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. BabySat is a step forward in solving some of these exact challenges by bringing real-time medical grade infant monitoring into the home, while under the supervision of a physician.
Food and DrugAdministration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. Today millions of Americans use DOACs, a highly effective and widely used drug for managing atrial fibrillation and deep vein thrombosis. DOACs can elevate bleeding risk and complicate emergency care.
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.
Food and DrugAdministration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). ” About Innoblative Innoblative is a medical device company dedicated to innovating advanced-energy solutions that improve the way physicians treat breast cancer and other soft tissue diseases.
Food & DrugAdministration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System. Utilizing expandable technology and robust plating options, TruLift Lateral and Lateral Plate System provide physicians with unique possibilities for their patient care.
Food and DrugAdministration (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. The Zoom RDL provided.088”
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