Pathway Genomics' direct-to-consumer cancer diagnostic earns FDA's ire

The FDA sent Pathway Genomics a warning letter asking the company for additional proof that its unapproved and unlisted CancerIntercept Detect blood test can detect various cancers. The "cancer stethoscope" is the only liquid biopsy that's sold directly to consumers.

FDA panel grills Bayer over Essure safety

Bayer has faced a rocky road with its contraceptive implant Essure, with the FDA launching an investigation earlier this year following claims of harmful--and in some cases, lethal--side effects and false trial data for the product. Now the company is facing more pushback after an FDA panel came down on the company for not collecting key safety data for its device.

NIH gives $1M to developer of ultrasound device for detection of postoperative blood clots

The NIH made a $1 million Small Business Innovation Research grant to Baltimore's Sonavex, a maker of ultrasound-based technology to detect postoperative clots.

Whoop raises $12M Series B for wearable tracking Olympians, professional and college athletes

Elite athletic organizations have a big investment in their roster. Now, startup Whoop has raised $12 million to help them track, analyze data and guide athletes to achieve peak performance and better realize their promise.

Politico: AdvaMed CEO Stephen Ubl to head Big Pharma lobbyist PhRMA

AdvaMed CEO Stephen Ubl is slated to become the next CEO of Big Pharma lobbying group PhRMA, multiple media outlets report. PhRMA says that a decision has not been made yet, but Politico reports that an official announcement could come as early as next week.

Study: 3-D tissue marker helps improve breast cancer monitoring, aids recovery

As physicians turn to next-generation devices to monitor breast cancer after surgery, a new study shows that Focal Therapeutics' 3-D tissue marker device could work alongside current screening methods to improve outcomes for patients.

Paraplegic walks by guiding a robotic skeleton with the brain via an EEG system

Robotic exoskeletons to enable paraplegics to walk that are manually controlled have been around for years; arm and hand prosthetics that can be mentally manipulated and enable sensation have also been developed. Now, researchers have combined some of these capabilities to enable a paraplegic to walk using a robotic exoskeleton controlled by the brain via an electroencephalogram (EEG)-based system.

EU regulators crack down on Brazilian devicemaker for implant safety scare

European regulatory authorities are cracking down on Brazilian devicemaker Silimed, suspending sales of the company's silicone implants for plastic surgery in light of safety concerns.

Stealth surgical robotics startup from Intuitive Surgical co-founder raises $150M

San Carlos, CA-based Auris Surgical Robotics has raised $150 million to back its almost entirely undisclosed mission, according to an SEC filing. This is the fourth robotic surgery co-founded by Dr. Frederic Moll, who helped found robotics surgery giant Intuitive Surgical.

St. Jude launches new patient-monitoring interface for CardioMEMS heart failure monitor

St. Jude Medical is rolling out a new interface for the display of data from its CardioMEMS heart failure monitor, which is projected to earn $286 million in 2017. Clinicians have begun accessing data collected by the implanted device via the same platform (dubbed used to monitor data from the company's implantable defibrillators and pacemakers.

Kimberly-Clark expanding access to nonsurgical OTC device for urinary incontinence

Kimberly-Clark announced that the first over-the-counter device cleared for temporary management of stress urinary incontinence is launching in retail stores across the U.S.

Startup submits novel biomarker for clinical trial medication adherence tracking to FDA

Proteus Digital Health and Otsuka submitted the first medication to incorporate adherence technology to the U.S. Food and Drug Administration for approval last week. Now, startup Xhale has submitted the first biomarker for medication adherence monitoring to the regulatory agency. Proteus obtained an FDA nod specifically for its medication adherence technology in July.

CliniCloud gets $5M seed round to launch connected medical kit at Best Buy

San Francisco, CA-based CliniCloud plans to launch its first product, a connected medical kit including a stethoscope and non-contact thermometer, at consumer electronics outlet Best Buy in the U.S. and Canada before then.

Institute of Medicine makes suggestions for improving accuracy of medical diagnoses

The nonprofit Institute of Medicine called for improving the quality of medical diagnoses in its latest "quality chasm" series of reports. Diagnostic errors account for about 10% of patient deaths and adverse events.

Four key medical device recalls of 2015

Earlier this year, FierceMedicalDevices decided to increase coverage of recalls due to the importance of patient safety and strong reader interest in the topic. This report serves to highlight and provide additional perspective on some of the recalls we've covered.

After IPO, Avinger snags up to $55M to back a 2016 launch for PAD lumivascular device

Avinger pulled off one of the first med tech IPOs of the year--raising $65 million in a January offering. Now, the image-guided catheter-based systems company has secured financing for up to $55 million under a new loan and equity agreement with CRG.

Nestlé seeks to deploy its diagnostics device for the early detection of Alzheimer's

Tech titans like Google, Samsung and Apple have clear med tech ambitions. Now a food giant is trying to grab a slice of the pie. The Nestlé Institute of Health Sciences SA seeks to deploy its proprietary diagnostic technology platform to develop an assay for the early detection of Alzheimer's.

GE Healthcare creates an emerging markets unit with $300M commitment

GE Healthcare has staked a major claim in a field that's not well tended--the development of affordable medical technologies to improve health outcomes in the emerging markets. It's creating a devoted business called Sustainable Healthcare Solutions out of a combination of its operations in India, South Asia, Africa and Southeast Asia dedicated to serving 70 markets--and investing $300 million to back the effort.

App maker settles with the feds over charges of improper marketing of vision improvement program

The Federal Trade Commission cracked down on Carrot Neurotechnology for making apparently unfounded claims that its Ultimeyes app is "scientifically shown to improve vision." The company agreed to stop making the statements, and disgorge $150,000 in profits.

UPDATED: FDA warns SynCardia's artificial heart could fail suddenly, as company seeks IPO

The FDA notified the public of a Class 1 recall of SynCardia Systems' Total Artificial Heart, saying a specific part of the device known as the Freedom Driver that operates and monitors the heart could fail.