After listening to the head of FDA’s device arm (CDRH), Dr. Jeff Shuren, speak at several conferences, certain lines become predictable and repetitive. One of them is a boast about the January 2015 approval of the Maestro Rechargeable System on the basis of a patient survey which found that the subjects had a higher risk tolerance than anticipated.
Google’s Baseline study is getting a boost, with a Harvard cardiologist moving over to lead the initiative almost a year after the company revealed its plans to aggregate molecular and genetic data to jump-start medical research.
As smartphone-based diagnostics pick up steam within the industry, researchers are harnessing the technology to develop an automated device that uses video to pinpoint parasitic worms from a single drop of blood, potentially cutting down on infectious diseases in Africa.
Fitness wearables player Fitbit has disclosed big plans for an IPO to raise up to $100 million–but there’s some speculation that this total could go over $400 million. The startup has had a phenomenal revenue trajectory so far and is on track to generate more than $1.2 billion this year, after already achieving profitability last year and maintaining that during the first quarter.
India is planning to open its first medical device industrial park in Gujarat, the state whose strong economic performance propelled Narendra Modi, its former chief minister, to the prime ministership. Discussions are underway for a second park in the south Indian state of Tamil Nadu.
WASHINGTON (AP) — Reality TV star Kim Kardashian is no stranger to criticism, having spent the better part of the last decade in the public eye. However, she hass probably never faced negative publicity like this before: The United States Food and Drug Administration says Kardashian’s social media posts violate federal drug-promotion rules.
A survey of the top 100 makers of medical devices in Asia indicates the industry will reach the $15 billion mark in 2017, a huge leap from a market of just $2 billion in 2012.
Almost a year after its proposal, the FDA finalized plans for an accelerated review program for critical medical devices, and said it will begin accepting applications to participate in the new pathway on April 15, 2015.
In response to repeated criticism that terminally ill patients find it too difficult to obtain access to experimental and potentially life-saving drugs, the U.S. Food and Drug Administration (FDA) has announced changes to its “compassionate use” process in the hopes of making it easier for physicians to request access to medical products on behalf of their patients.
The U.S. Food and Drug Administration (FDA) could stand to lose all of its authority to regulate food products, potentially including dietary supplements, under a new proposal unveiled by President Barack Obama in early February 2015.