Overweight is generally defined as a body mass index (BMI) between 25 and 29.9 kg/m2 in adults. A BMI ≥30 is considered obese (criteria differ slightly in Asian patients). In patients with an elevated BMI, a 5-10% reduction in weight has been associated with a reduction in the risk of developing type 2 diabetes, hypertension, and dyslipidemia. Diet, exercise, and behavior modification are the traditional methods for losing weight, but they are often inadequate; the American College of Cardiology no longer recommends that all patients try lifestyle modification alone before adding...

Health care professionals may be asked about lowvoltage electronic devices now being used to diagnose and/or treat a number of health problems. Most are galvanometers that measure skin resistance to an electric current. The FDA classifies "devices that use resistance measurements to diagnose and treat various diseases" as Class III devices that require FDA approval prior to marketing. None of the devices reviewed here has such approval.

The FDA has approved the use of a responsive neurostimulator device (RNS System – NeuroPace) for adjunctive treatment of adults with partial-onset seizures that are not controlled with ≥2 antiepileptic drugs and who have frequent and disabling seizures and no more than 2 epileptogenic foci.

The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

The FDA has approved the use of a transcatheter mitral valve device (MitraClip – Abbott) for percutaneous treatment of significant symptomatic degenerative mitral regurgitation (grade 3-4+) in patients who are at prohibitive risk for mitral valve surgery. It is the first percutaneous nonsurgical treatment approved for this indication.

An automatic, noninvasive, glucose-monitoring device (GlucoWatch Biographer) has been approved for marketing by the FDA. The manufacturer states that it is not meant to replace a regular blood glucose meter.

The FDA had approved an intrauterine contraceptive device that releases the synthetic progestin levonorgestrel over a period of five years. The device has been available in Europe for 10 years.

The FDA has authorized use of Teal Wand (Teal Health), an at-home vaginal sample self-collection device, for cervical cancer screening.

The PCSK9 inhibitor evolocumab (Repatha – Amgen) is now available in a single-dose, hands-free device (Repatha Pushtronex) for once-monthly subcutaneous infusion. Evolocumab is FDA-approved as an adjunct to diet and maximally tolerated statin therapy for patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol (LDL-C), and as an adjunct to diet and other LDL-lowering therapies for patients with homozygous familial hypercholesterolemia (HoFH).Evolocumab is also...

The FDA has approved the use of a transcutaneous electrical nerve stimulation device (Cefaly – Cefaly Technology) for prevention of episodic migraine in patients ≥18 years old. The first device to be approved in the US for migraine prevention, it is available in Canada and Europe for treatment and prevention of migraines. A transcranial magnetic stimulation device (SpringTMS - eNeura Therapeutics) recently approved by the FDA for treatment of migraine preceded by aura will be reviewed in a future issue.