How to Survive Medtech 's 'Death Valley '

Medical device companies attempting to market a new treatment in the U.S. often make the erroneous assumption that winning FDA approval is the final destination, and success is theirs. In fact, going through the regulatory process is only the halfway point. The grueling path from FDA approval to reimbursement is like a treacherous walk through Death Valley and many companies don’t make it through. In this case study, I discuss the trials and triumphs of bringing robotic high intensity focused ultrasound (HIFU), a non-invasive procedure for localized prostate cancer, to the U.S. I'll shares lessons learned as EDAP TMS began its 14-year journey, starting with the FDA pre-market approval (PMA) process, shifting to the more expedient de novo 510(k), and winning FDA clearance. Then getting through the Death Valley gauntlet to finally win the American Medical Association’s (AMA) approval of a new Category 1 CPT code for treating prostate cancer, and reimbursement from insurers.   Jumping Through Hoops: The Rigors of FDA Approval We faced a protracted process when we first applied for a PMA for EDAP’s first HIFU device. HIFU is a non-invasive option that had been in use in Europe, Asia, and South America since 2000.  It allows the surgeon to destroy only the diseased portion of the prostate, thereby preserving healthy surro...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Business Source Type: news

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Publication date: Available online 14 September 2019Source: Journal of Advanced ResearchAuthor(s): Simone Kumstel, Praveen Vasudevan, Rupert Palme, Xianbin Zhang, Edgar Heinz Uwe Wendt, Robert David, Brigitte Vollmar, Dietmar ZechnerAbstractProspective severity assessment is legally required in many countries to ensure high-quality research along with high welfare standards for laboratory animals. Mice and rats, the most common laboratory species, are prey animals that usually suppress signs of pain and suffering. Therefore, highly sensitive readout parameters are necessary to adequately quantify distress. The present stud...
Source: Journal of Advanced Research - Category: Research Source Type: research
Authors: Reinert T, Coelho GP, Mandelli J, Zimermann E, Zaffaroni F, Bines J, Barrios CH, Graudenz MS Abstract Mutations in the ESR1 gene (ESR1m) are important mechanisms of resistance to endocrine therapy in estrogen receptor-positive advanced breast cancer and have been recognized as a prognostic and predictive biomarker as well as a potential therapeutic target. However, the prevalence of ESR1m in real-world patients has not been adequately described. Therefore, we sought to evaluate the prevalence of ESR1m in metastatic samples from Brazilian patients with estrogen receptor-positive (ER+) advanced breast cancer...
Source: Journal of Oncology - Category: Cancer & Oncology Tags: J Oncol Source Type: research
Just did a question on uworld where patient needs a endarterectomy. I consulted vascular surgery but they said no recommendations at this time, even after getting a carotid ultrasound. I was reading up on previous threads and not sure what the right move is. On the real test, am I supposed to proceed with the endarterectomy if the consultant doesn't give any recommendations, or are they always supposed to give a recommendation if you sequence everything correctly on the real thing?
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Step III Source Type: forums
Publication date: Available online 14 September 2019Source: Academic RadiologyAuthor(s): Valentin Quack, Marcel Betsch, Julian Hellmann, Jörg Eschweiler, Simone Schrading, Matthias Gatz, Björn Rath, Markus Tingart, Markus Laubach, Christiane K. Kuhl, Timm DirrichsRationale and ObjectivesUp to now, the diagnosis of tendinopathies is based on conventional B-mode-ultrasound (B-US), Power Doppler-ultrasound (PD-US), and magnetic resonance imaging. In the past decade, Shear Wave Elastography (SWE) has been introduced in tendon imaging, for example in athletes or patients suffering from tendinopathy. SWE allows real-ti...
Source: Academic Radiology - Category: Radiology Source Type: research
Publication date: Available online 13 September 2019Source: Social Science &MedicineAuthor(s): Piper SledgeAbstractIn this paper, I draw on the narratives of 57 individuals whose gender identities and decisions about their bodies trouble the medical protocols for breast and gynecological cancer care. I focus here on the decision-making process for three groups of elective surgeries: hysterectomy, prophylactic bilateral and contralateral mastectomy, and breast reconstruction. These elective surgeries illustrate places in medical interactions where patients and providers rely on frames of gender to determine whether a gi...
Source: Social Science and Medicine - Category: Psychiatry & Psychology Source Type: research
ConclusionResults of our study highlighted the possible role of fat in breast cancer progression suggesting a negative prognostic value of IDFi.
Source: Pathology Research and Practice - Category: Pathology Source Type: research
Authors: Gameon JA, Skewes MC Abstract American Indian/Alaska Native and First Nations communities suffer from health disparities associated with multiple forms of trauma exposure. Culturally appropriate interventions are needed to heal current and historical trauma wounds. Although there are evidence-based trauma interventions for other populations, few have been implemented or evaluated with Native communities. Understanding the extant research on trauma interventions in Native communities is crucial for advancing science and filling gaps in the evidence base, and for meeting the needs of underserved people. In t...
Source: American Journal of Community Psychology - Category: Psychiatry Tags: Am J Community Psychol Source Type: research
In conclusion, BetaSweet carrots exhibits multiple health benefits to use as functional foods.Graphical abstract
Source: Journal of Functional Foods - Category: Nutrition Source Type: research
Conclusion: CAT outperformed CCQ and SGRQ, and it increased the explanatory power of VAS. EBV combined with CAT seems superior to only generic or disease-specific approaches. PMID: 31512524 [PubMed - as supplied by publisher]
Source: Expert Review of Pharmacoeconomics and Outcomes Research - Category: Health Management Tags: Expert Rev Pharmacoecon Outcomes Res Source Type: research
AbstractBackgroundThe Aphasia Rapid Test (ART) is a screening questionnaire used for examining language in acute stroke patients. The ART was initially developed and validated in French. The purpose of this study was to assess the inter-rater reliability of Italian ART.MethodsThe original version of the ART was translated into Italian. The inter-rater reliability was assessed by two independent neurologists who were blind to each other ’s ratings in 52 acute post-stroke patients.ResultsThe 52 patients (28 men, 24 women; mean age 73.73  ± 28.99 years) were included within 1 week of strok...
Source: Neurological Sciences - Category: Neurology Source Type: research
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