Medical Regulation > Nova Content
The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De ... Read More »
The FDA recently cleared Prescient Surgical’s CleanCisionTM Wound Retraction and Protection System (CleanCisionTM), a retractable device designed to... Read More »
Medical imaging isotopes are used to diagnose various diseases, such as cancer and coronary artery disease, and to evaluate brain, lung, kidney, and liver... Read More »
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the... Read More »
The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press... Read More »
The Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System... Read More »
On January 22, 2018, a $50 million lawsuit was filed against the U.S. Food and Drug Administration (FDA) in the Central District of California. The complaint was... Read More »
Global medical device company Boston Scientific has announced on January 24, 2018, an agreement to make a $90 million investment in privately-held medical device... Read More »
According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s... Read More »
Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According to... Read More »
The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients. ... Read More »
The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests... Read More »
The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications... Read More »
Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to... Read More »
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary... Read More »
On October 24, 2017, the FDA announced new steps that it is taking to promote beneficial medical device innovation.
First, the FDA completed a first qualification ... Read More »
The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5... Read More »
In Bayer v. Watson, the panel throws out Bayer’s patent to its Staxyn erectile dysfunction drug as being obvious, noting that the district court focused too... Read More »
Written by Robert J. Hilton, Ph.D. and Jing Liu, Ph.D.
On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa... Read More »
Written by Scott Siera, Ph.D. and Eric Furman, Ph.D.
Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S... Read More »