For overweight people who have difficulty losing the pounds or keeping them off, there’s a new medical device, pending approval from the U.S. Food and Drug Administration (FDA), that could suppress their appetites and cut down on their between-meal snacks. The manufacturers of the device, called Abiliti, made by IntraPace of Mountain View, CA, claim [...]
Hearing Aids More Sophisticated, Smaller
October 16, 2012 By 3 Comments
Hearing aids may be undergoing a revolution, with new devices coming on the market that do not need approval from the U.S. Food and Drug Administration (FDA) and can help people with near-normal hearing hear better. The new wave of devices — called personal sound amplification products, or PSAPs — are smaller and sold over [...]
Medical Device Alerts Wearer About Heart Attack
October 5, 2012 By Leave a Comment
Of the 750,000 Americans who have a heart attack each year, 195,000 — one in five — will have the so-called silent symptoms, with none of the traditional signs, like pressure on the chest or pain down the left arm. The problem is that most of the damage to the heart occurs within 90 minutes [...]
FDA Proposes Rule on Medical Device Identifier
July 10, 2012 By Leave a Comment
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require manufacturers to place a unique device identifier (UDI) on medical devices, with the aim to facilitate the reporting of adverse events related to those devices so that the agency could address them more quickly, including possible recalls. The UDI would [...]
Breast Cancer Detection Device Gets Nod from FDA
July 5, 2012 By Leave a Comment
An advisory panel from the U.S. Food and Drug Administration has favorably recommended the U.S. use of a real-time breast cancer detection device that is used in the operating room. The medical device, manufactured by Dune Medical Devices Ltd. in Framingham, Mass., tests whether all tumor tissue has been removed in surgery, reports Gali Weinreb [...]
Hope for Patients With High Blood Pressure
June 25, 2012 By Leave a Comment
People with high blood pressure that does not improve with medication may have some help on the way, thanks to a new medical device that is in the beginning stages of testing in the United States. Manufactured by Medtronic, the device burns nerves that lie next to the renal arteries to the kidneys, disrupting the [...]
Artificial Pancreas Device Undergoing Tests
June 14, 2012 By 1 Comment
For people with Type 1 diabetes, monitoring their blood sugar level is a constant task. “The first thing I do when I wake up is check my blood sugar,” says Terra Hillyer, who has the disease. “It is the background noise of my life.” In Hillyer and others with the disease, the pancreas fails to [...]
FDA Authorization Bill Heads to Conference
June 4, 2012 By 1 Comment
The Senate and House of Representatives have passed their bills that authorize the U.S. Food and Drug Administration (FDA) to collect user fees so that the agency can review new drugs and medical devices, and they are heading to a conference to be reconciled. The legislation reauthorizes the FDA’s drug and medical user fee programs [...]
Wireless Defibrillator Gets Closer to Approval
May 8, 2012 By Leave a Comment
A U.S. Food and Drug Administration (FDA) panel has backed a new type of implantable heart defibrillator, but before the medical device gets full approval, other concerns will need to be addressed. What is new about the device — developed by Cameron Health Inc. — is that it is implanted underneath the skin and does [...]
Is FDA Stifling Medical Device Innovation?
June 28, 2011 By Leave a Comment
Just like teenagers complain that their parents don’t let them be, it’s expected that medical device and other biomedical companies will complain that the U.S. Food and Drug Administration (FDA) slows them down. But it may be more serious than that. Timothy Hay reports in the Venture Capital Dispatch blog of The Wall Street Journal [...]
