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FDA to allow midstream changes to device trials as part of effort to speed up approvals

The FDA continued its focus on improving the clinical trial paradigm with this week’s issuance of a draft guidance on adaptive designs for medical device clinical studies.  Similar to a prior guidance on the incorporation of patient preference data in clinical trials, the latest guidance should help companies perform trials faster, and signals greater flexibility on the behalf of the FDA.  The Agency seeks to bring more trials stateside and approve medical technology at a quicker pace.

In new guidance FDA says it may approve devices for use by certain subpopulations only

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 signs on Harvard doc to lead bioinformatics study

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.

Smartphone-based diagnostic device detects parasitic worms via video

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.

Fitbit files for up to $100M IPO as it dominates fitness wearables and aims for corporate wellness

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.

FDA issues Warning Letter over Kim Kardashian’s promotion of morning sickness drug

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.