Smartphones, they may just save our lives
I’m not sure if Alexander Graham Bell -- the Steve Jobs of the late 19th and early 20th centuries; a brilliant scientist and the inventor of the first telephone; and a man that actually found the...
View Article22 Novel Drugs Approved by FDA in 2016
Written by Jane Xia and Jason J. Jardine Every year, the FDA’s Center for Drug Evaluation and Research (CDER) approves new medications. Some medications are variations of existing products, such as...
View ArticleFDA Provides Guidance on 3D-Printed Medical Device Products
The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of...
View ArticleFDA Announces Plans for Alternative Clearance Pathway
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Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new,...
View ArticleAkili Interactive Announces Trial Results for Video Game Treatment of ADHD
Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to file AKL-T01 with the U.S. Food and Drug...
View ArticleFDA Issues Draft Guidance for “Least Burdensome” Approach to Device Regulation
The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.” The FDA...
View ArticleFDA Pre-cert Program for Lab-Developed Tests
The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests themselves. The American Clinical Laboratory...
View ArticleFDA Approves Prickless Glucose Monitoring System
The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients. The glucose monitoring tool will allow patients...
View ArticleMedtronic Pain Management Device Approved by FDA
Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According to Medtronic, the Intellis platform features the...
View ArticleFirst-Ever De Novo Clearance by FDA’s Orthopedic Branch
According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone...
View ArticleFirst Prosthetic Iris Approved
On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted...
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