Regulators in the European Union green-light St. Jude Medical's Ilumien Optis 3D vessel reconstruction technology to guide coronary stent placement.
St. Jude Medical (NYSE:STJ) today announced CE Mark approval of its Ilumien Optis PCI optimization system, designed to help physicians assess and treat patients with coronary artery disease.
The FDA warns healthcare providers of a Class I recall of some of Maquet Cardiovascular's malfunctioning battery units.
A Class I recall, reserved for serious patient harm, was issued over battery units produced by Getinge (PINK:GETI B) subsidiary Maquet Cardiovascular.
California mobile medical device maker AliveCor releases a new model of its ECG monitoring and recording technology to fit the size and shape of the iPhone 5 and plans to hand out free samples at the Heart Rhythm Society meeting in Denver, Colo.
California startup AliveCor updated its heart monitor to make it compatible with the next-generation iPhone 5. The company's mobile ECG snaps on to the outside of an iPhone with sensors that monitor and record electrocardiogram rhythms wirelessly.
AtriCure reports 1st-quarter sales growth but wider losses.
AtriCure (NSDQ:ATRC) reported increased 1st-quarter sales and affirmed its 2013 sales and earnings guidance.
The West Chester, Ohio-based medical device company posted losses of $1.9 million, or -10¢ per share, on sales of $19.4 million for the 3 months ended March 31, for top-line growth of 11.2%. Losses were up 19.9% compared with Q1 2012.
CardioFocus raises $11 million for its HeartLight endoscopic ablation system in a round of debt financing from Oxford Finance and Silicon Valley Bank.
CardioFocus added $11 million to its coffers in a round of debt financing from Oxford Finance and Silicon Valley Bank as it commercializes its HeartLight endoscopic ablation system overseas and winds up enrollment in a pivotal U.S. trial.
CardioFocus CRO Renny Clark said the funds will help the company prepare for its submission to the FDA for the HeartLight device, which combines an endoscope and a laser ablation device, according to a press release.
A civil trial against Dr. Mark Midei, the cardiologist stripped of his Maryland license to practice medicine for alleged "over-stenting," settles a day before Midei's scheduled testimony.
The civil lawsuit filed by former patients against cardiologist Dr. Mark Midei and his former employer over alleged over-stenting settled on the eve of Midei's testimony, reportedly without his agreement.
The lawsuit was filed against Midei and Catholic Health Initiatives, owner of the St. Joseph Medical Center where Midei practiced, by the more than 200 patients he's accused of implanting with unnecessary stents.
By 2030 every taxpayer will be paying $244 per year to care for heart failure patients, according to a report from the American Heart Assn.
MASSDEVICE ON CALL — The direct and indirect costs of treating patients with heart failure could reach $70 billion by 2030, more than doubling from the $31 billion in costs for 2012.
That would put every U.S. taxpayer on the hook for $244 per year as the number of patients suffering from heart failure climbs 46% to 8 million people in 2030, according to a report by the American Heart Assn.