News

Olympus asked FDA to loosen its belt on cleaning guidelines for endoscope devices

Olympus is facing more pushback over endoscopes tied to drug-resistant superbug outbreaks at U.S. hospitals, as new reports show the company asked the FDA to soften its guidelines on cleaning procedures for the products.

Startup gets FDA nod for device to deter severe GERD condition

The FDA has cleared a neck-worn device to reduce the symptoms of laryngopharyngeal reflux. That condition occurs once gastroesophageal reflux disease (GERD) is so severe that stomach acid travels up the esophagus and into the throat.

Texas Medical Center adds 20+ device companies to its incubator

Houston is synonymous with oil and gas, but the inaugural class of the Texas Medical Center's TMCx accelerator attests to the city's med tech ambitions. Essentially, all of the 22 startups are in the device or health IT arena. There isn't a pure-play drug developer in the mix.

Merck Serono, Illumina partner in the latest universal next-gen cancer diagnostic deal

Cancer diagnostics has long been defined by the aim of providing "personalized" and "precision" medicine to patients. But now the buzzword of the moment seems to be trending more toward "universal"--as the industry strives for an all-encompassing test that will mete out the best possible individual treatment protocols based on genomic data.

English team develops robot for stroke rehabilitation

Researchers at England's University of Hertfordshire have designed a robotic glove to help victims of stroke rehabilitate.

Sequenom's noninvasive prenatal diagnostic uncovers signs of cancer in 40 women

Sequenom has long depended on its noninvasive prenatal diagnostic test to drive growth and fuel expansion. But now, the company unveiled new results which show that its MaterniT21 test can detect signs of cancer in pregnant women, a potential game-changer as Sequenom looks to expand its market reach.

Startup gets $9.3M Series B for high-performance ultraviolet LED disinfection

RayVio is promising a high-performance, low-cost ultraviolet LED system that can be used to aid in disinfection across industrial, commercial and consumer sectors. To support this ambition, the startup has raised a $9.3 million Series B financing.

Drawing blood glucose sensors on your body: The future of diagnostics?

It's one of those ideas that sounds wacky and way out there, but researchers at the University of California, San Diego, have apparently found a way to draw a blood glucose sensor onto a patient's skin using regular ballpoint pen.

Veniti raises $17M to complete pivotal venous stent trial aimed at FDA approval

Veniti started its 200-person trial of the Vici Venous Stent System on Dec. 1. Now it's got more than $17 million to complete that trial that is targeting a U.S. approval to treat venous disease.

Apple announces open-source data-collection platform for mobile medical apps

In typical Apple style, CEO Tim Cook announced the debut of its open-source platform for creating mobile medical apps while standing in front of a black background at a glitzy event in San Francisco. But the news contained substance too, at least from a med tech perspective.

Study: FDA-cleared biomarker can reduce ADHD overdiagnosis

A new study suggests that integrating a biomarker based on data from an electroencephalogram can offer pediatricians a more accurate way to diagnose attention deficit hyperactivity disorder (ADHD) in children, thereby helping to eliminate unnecessary drug therapy.

AliveCor launches upgraded app for detecting a common warning sign of stroke

AliveCor's latest upgrade to its AliveECG app for detecting a sign of stroke known as atrial fibrillation includes a detector to inform patients when their reading is normal and an interference detector to ensure that all results are high quality and readable by physicians.

FDA approves novel CPR system, just after Zoll acquires its maker

The U.S. Food and Drug Administration has approved the ResQCPR System to perform cardiopulmonary resuscitation (CPR) on cardiac arrests patients. The CPR system is from startup Advanced Circulatory Systems, which was acquired for an undisclosed amount by Zoll Medical in January.

Med tech industry's expenditure on lobbying at an all-time high

The medical device tax is costing the med tech industry money--and so is lobbying to get rid of it.

China's Mindray jumps on acquisition rumor involving state-owned investment firm

The share price of China's Mindray Medical rose 16% last week on the New York Stock Exchange amid rumors that it will be taken over by private equity firms, including the country's state-owned investment company.

Cannabis-based startup raises $6.9M to sell $700 personal chemical analyzer

Startup CDx has raised its first institutional round of $6.9 million to market its portable chemical analyzer, MyDx. The device is intended to provide consumers with data about the chemicals in practically anything they are eating, drinking and breathing. So far, 105 investors are participating in the latest financing, which the company hopes will top out at $8 million.

Patient advocates call for increased transparency as superbug tied to endoscopes continues

As the drug-resistant "superbug" outbreak tied to endoscopes rages on, patient advocates and healthcare groups are calling for increased transparency about the devices from regulators and providers.

FDA approves novel blood purifier that treats rare condition in hemodialysis patients

The FDA just approved a first-of-its-kind blood purifier to treat a complication of kidney failure under its pathway for medical devices that treat rare conditions.

Icon launches new medical device research division

CRO giant Icon continues to expand its portfolio of offerings with the launch of a new medical device and diagnostics research group.

Siemens healthcare biz spinoff slated for May

Siemens will officially spin off its healthcare business into a separate company as of May 1, according to a report by Reuters. That's earlier than the second half of 2015 timing the company had previously cited.