Design & Testing

On October 14, the FDA issued a draft guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The studies utilized for the assessment of these devices typically provide initial evidence of device...

VeloX, a prosthetic heart valve developed by National University of Singapore researchers, can be implanted through a small incision for the treatment of a serious heart valve disorder called mitral regurgitation. The device is particularly beneficial to patients who are of high surgical risk or are...

Recently, an online discussion board broached the subject of FDA approval for a diagnostic app that might be able to predict when a patient’s condition would relapse. The question postulated whether there was a way to circumvent FDA approval by launching the app in another country and making it available online. And, if...

While historically, the development of new technologies to improve patients’ lives has relied upon experts’ opinions rather than asking patients and families directly what they consider important, this may be about to change. Patients and their care partners are becoming intimately...

A team of Johns Hopkins University scientists discovered that noninvasive brain stimulation temporarily improves motor symptoms in patients with Parkinson's disease (PD). The Johns Hopkins study also revealed that people with Parkinson's disease are still capable of making quick,...

OpenFDA is releasing a treasure trove of information on medical devices that could help spur innovation and advance scientific research. OpenFDA’s Application Programming Interface (API) expands the previous resources about medical device-related adverse events and recalls by incorporating information...

The FDA is seeking companies to take part in a pilot program that would allow medical device manufacturers to report malfunctions of certain low- and medium-risk devices on a quarterly basis. This pilot program will help the agency develop criteria for quarterly malfunction reporting...

The Emergo Group recently posted an advisory that the FDA has revised the fee charged for issuing medical device export certificates in response to higher costs and demand for these documents.

In mid-July, the House of Representatives passed HR 6, also known as the 21st Century Cures Act, which expedites research and development on debilitating diseases and makes it easier to get important treatments to the patients who need them. Among other things, it makes research collaborations easier, reforms and streamlines...

There’s no doubt that additive manufacturing (AM), including emerging 3D printing technologies, is booming. Despite its promise though, AM still has far to go to in understanding the impact of subtle differences in manufacturing methods on the properties and capabilities of resulting materials....

The FDA is seeking comments of a new draft guidance that it recently issued for industry called “Adaptive Designs for Medical Device Clinical Studies.” An “adaptive design” for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications...

Using nanowires, Purdue University researchers has created a new implantable drug-delivery system that can be wirelessly controlled. The nanowires respond to an electromagnetic field generated by a separate device, which can be used to release a pre-loaded drug. The engineering team says that...

The U.S. Food and Drug Administration has withdrawn 47 draft guidance documents published before December 31, 2013, which were never finalized or acted on. The announcement was posted in the Federal Register, stating that this move was made to improve the efficiency and transparency of the guidance...

This invention places a drug delivery system inside a prosthetic implant to circumvent the physical issues encountered after fitting the implant. Implants being relatively large in size would be able to house the drug-carrying device inside them without compromising the structural integrity or the...