A review of the FDA's 510(k) approvals process for electromagnetic devices used in body contouring.

In this study, we aimed to characterize the evolution and safety of electromagnetic devices marketed in the U.S. over the last two decades. METHODS: We examined records from a U.S. FDA database documenting premarket approval of electromagnetic devices between January 1, 2000 and October 31, 2018. Additionally, we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports of adverse events. RESULTS: Thirty-one devices were approved from 2012-2018. Initially marketed to temporarily reduce muscle pain and cellulite, indications for these devices have expanded. The MAUDE database revealed 61 reports of adverse events including acute skin damage, dyspigmentation, infection, hair growth, scarring, and others. DISCUSSION: Although electromagnetic devices are gaining increasing public attention and marketed to be safe, the frequency and types of adverse events are not well-documented. Importantly, the MAUDE database has limitations including submission of incomplete, inaccurate, untimely, or unverified data make determining the true number of adverse events difficult. Further investigation is greatly needed to define appropriate parameters and outcomes for the use of electromagnetic devices in body contouring and skin enhancement. PMID: 30614316 [PubMed - as supplied by publisher]
Source: Journal of Dermatological Treatment - Category: Dermatology Tags: J Dermatolog Treat Source Type: research

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Surgeons' fears at staff performing heart and orthopaedic ops after just 2 years training | Express.co.uk HUNDREDS of medical staff performing heart and orthopaedic procedures after just two years of training need better regulation, says Britain's largest surgical college. www.express.co.uk
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Pain Medicine Source Type: forums
Authors: Martínez-Acitores D, Hernández Ainsa M, Cortés García L, Bengochea Martínez ML, Palacios Fanlo MJ Abstract Ectopic hepatocellular carcinoma is a rare entity. Most cases are asymptomatic and are occasionally found during autopsy or laparoscopy. They may sometimes cause relevant clinical problems such as abdominal pain or intra-abdominal bleeding. In this clinical case report, we review the literature in order to decipher the case of a 68-year-old female with an ectopic hepatocellular carcinoma that arose from the peritoneum. The patient was diagnosed after being studied du...
Source: Revista Espanola de Enfermedades Digestivas - Category: Gastroenterology Tags: Rev Esp Enferm Dig Source Type: research
The objective of this study was to compare the practices of surgeons in France versus other countries regarding the diagnosis and treatment of IIS.HypothesisDiagnostic and therapeutic practices regarding IIS differ between surgeons in France and in other countries.Material and methodsA 21-item questionnaire in French and English was emailed to the 1300 members of the French Arthroscopy Society and to surgeons from countries other than France. The questionnaire collected information on knowledge about IIS (2 items), the frequency of IIS in clinical practice (2 items), the diagnosis of IIS (6 items), the non-operative and su...
Source: Orthopaedics and Traumatology: Surgery and Research - Category: Orthopaedics Source Type: research
No abstract available
Source: The Back Letter - Category: Orthopaedics Tags: Articles Source Type: research
DEBORAH MEADEN is a multi-millionaire businesswomen and fellow dragon on the hit BBC show, Dragon ’s Den. The business mogul revealed she suffers from a painful condition that was originally brought on during her stint on Strictly Come Dancing six years ago.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Authors: Zhou ZG, Liu R, Tan HL, Ji XY, Yi XL, Song JF Abstract OBJECTIVE: The paper aims to explore the application of dexmedetomidine combined with dezocine in thoracoscopic radical resection of lung cancer and its effect on the awakening quality. PATIENTS AND METHODS: 122 patients undergoing thoracoscopic radical resection of lung cancer in The Affiliated Hospital of Qingdao University from April 2009 to January 2012 were selected as the subjects of the study. Among them, 68 patients were anesthetized with dexmedetomidine combined with dezocine as a study group, 54 patients with midazolam combined with fenta...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
We describe a patient who consumed undercooked chicken wings, with subsequent development of a febrile gastrointestinal illness marked by copious, watery stool output. This was followed by acute onset of pain and inability to bear weight on his right hip and leg where he had undergone prior arthroplasty. Synovial fluid cultures revealed Campylobacter coli, identified utilizing matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. The patient made a full recovery following hip joint space debridement with prosthesis retention, coupled with sequential intravenous and oral ciprofloxacin therapy. This c...
Source: IDCases - Category: Infectious Diseases Source Type: research
ConclusionsAnalysis of Penn OM clinical practices emphasizes the breadth and multidisciplinary nature of OM services and importance of comprehensive postdoctoral training in all domains of OM.
Source: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology - Category: ENT & OMF Source Type: research
ConclusionThese results demonstrate that AOE exerts potent anti-inflammatory effects and may be a useful therapeutic candidate against OA.
Source: Phytomedicine - Category: Drugs & Pharmacology Source Type: research
ConclusionsFor necrotic immature teeth, revascularization using PRP is an appropriate alternative to PRF and showed excellent 12-months prognosis.
Source: The Saudi Dental Journal - Category: Dentistry Source Type: research
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