News

Myriad wins, and investors cheer, at CMS's move to reduce coverage cuts for BRCA tests

Myriad Genetics had warned that CMS reimbursement for its BRCA predictive cancer tests could drop by close to 50% this year. Payments are indeed declining, but the Utah diagnostics company disclosed in a recent regulatory filing that they won't drop nearly as much as previously expected.

After a successful IPO, LDR looks to raise more cash

LDR, the cervical disc replacement provider that brought you the first pure-play medical device IPO of 2013, is looking to raise more cash via a secondary offering.

Biotronik proceeds with MRI-safe ICD study in the U.S. as initial patients join in

A few weeks after the FDA allowed Biotronik to expand its ProMRI trial to implantable cardioverter-defibrillators, the company hasn't wasted any time moving ahead. The German cardiac device company said it performed initial ICD surgeries for the study at hospitals in Connecticut, Pennsylvania, North Carolina, Michigan, Virginia, New York and Oregon, generally involving its Iforia devices.

Indiana governor's letter to Obama latest salvo against device tax

A letter from Indiana Gov. Mike Pence imploring President Barack Obama to repeal the 2.3% medical device industry tax helping fund the federal healthcare law is the latest salvo in a battle the industry said is causing job casualties and draining funds for research and development.

Foundation Medicine teams up with Clovis Oncology to develop ovarian cancer Dx

Foundation Medicine recently revealed plans to raise up to $150 million in a secondary offering to fuel R&D and announced on Thursday that it is teaming up with Clovis Oncology to develop an innovative companion diagnostic for ovarian cancer.

My sister, and life science's limits

On a cold January morning in 2013, my big sister, Gretchen, took her last, labored breath and died. She was 46. Over the course of her last month alive, I developed a growing sense of anger and desperation at how her doctors, as well as the drug and diagnostics industries, seemed to have failed her.

Cardinal Health will snatch up AccessClosure for $320M

Cardinal Health is snatching up California devicemaker AccessClosure for $320 million in cash, a deal that will give the Ohio healthcare services giant a line of cutting-edge vascular closure surgical devices.

Dental implant giant Straumann invests $30M into low-cost South Korean competitor

Straumann, the Swiss dental implant giant, is sinking $30 million into a low-priced competitor in South Korea with an option to buy a majority stake down the line.

Thoratec smacked with FDA Class I recall concerning heart pump backup controllers

A formal recall of Thoratec's backup power device used with its HeartMate pumps is now in place, and the FDA slapped a Class I status on the effort, its most serious designation, which means the issue can result in serious injury or death.

GE Healthcare makes a buyout deal in hospital management tech

GE Healthcare is looking to cash in on the march toward hospital efficiency. It announced the acquisition of operating room management and analytics solutions provider CHCA Computer Systems today for an undisclosed amount. The deal is expected to close in the second quarter of 2014.

Four months later, 23andMe's clash with the FDA remains unresolved

In the four months since 23andMe agreed to stop selling all health-related genetic tests in the U.S. while it submits them for a formal FDA review, the California company's future has become cloudier, not clearer.  A recent blog post on its web site informed customers that executives continue to meet with regulators, but a resolution to the matter doesn't appear to be anywhere close to happening.

Boston Scientific touts promising trial data for its transcatheter heart valve

It's a crowded market for transcatheter aortic devices, and Boston Scientific is trying to get a leg up on the competition. The company is celebrating positive study results for its transcatheter aortic valve replacement, touting data that it hopes will set it apart from its market rivals.

Cepheid's 60-minute HPV test is now available in Europe

Cepheid announced Wednesday it has released Xpert HPV for sale in Europe. The fast test is designed to detect cervical-cancer-related human papillomaviruses (HPV) in women and return results in an hour.

German prosthetics company moves U.S. arm from Minneapolis

States in the U.S. are competing rabidly with each other for med tech jobs. If you don't believe this, consider some recent news involving Ottobock HealthCare.

Investors endorse Intuitive's rollout of a next-gen surgical robot

Investors drove Intuitive Surgical's stock price more than 8% higher in early trading April 1 in response to the U.S. rollout of yet another iteration of its da Vinci surgical robot--a bid to expand its use and counter slumping sales.

China's Dehaier Medical continues its turnaround as revenue falls

Dehaier Medical Systems' turnaround hasn't paid off yet. The Chinese medical device maker spent 2013 reorienting its business towards government procurement and sleep respiratory devices, and away from the increasingly competitive medical equipment business. Amid the refocus, annual revenue declined 21.11% to $16.86 million and net income fell to $2 million in 2013 from $3.22 million during 2012.

Covidien CFO deals his stock options near the company's 52-week high

Covidien's stock hit a 52-week high in the last week, and Chief Financial Officer Charles Dockendorff exercised his option to buy close to 91,000 company shares at just over half their market price in the midst of the Irish medical device giant's upward trajectory.

GE Healthcare unit recalls infant warmer systems in China

A GE Healthcare unit recalled hundreds of infant resuscitation devices in China after uncovering potential safety issues. The recall coincides with China's latest regulatory action, which calls for more stringent oversight of medical device makers.

IPO emigre Lombard Medical looks to raise $60M in a Nasdaq debut

Stentmaker Lombard Medical has set the range for its pending U.S. IPO, aiming to raise $60 million with the sale of 3.6 million shares priced between $15 and $18.

Sorin scores expanded CE mark for its Perceval sutureless aortic valve

Sorin knows that it needs to reach the widest patient population possible to succeed in the cardiac marketplace. With that in mind, the Italian cardiac medical device company can celebrate its new CE mark allowing its Perceval sutureless aortic valve to be used for all adults with aortic stenosis and related problems.