News

Hillary Clinton hedges on the device tax, says nation must weigh pros and cons

In a speech emphasizing the importance of compromise, likely presidential candidate Hillary Clinton said that there may be room for that dirty word in Washington when it comes to repealing the 2.3% medical device tax. That is a key demand of Republicans, not to mention of the device industry.

Boston Scientific wins positive recommendation from FDA panel for stroke-fighting Watchman device

Boston Scientific won a positive recommendation from an FDA panel for its stroke-fighting Watchman device, even as panel members expressed doubt that the product would work well in patients who are eligible for traditional drug therapy.

CoheroHealth to pilot asthma inhaler sensor and app at Mount Sinai Medical Center

Startup CoheroHealth, developer of the AsthmaHero app and spirometer for measuring the volume of air inhaled and exhaled by the lungs, will test its solution on 50 patients at New York City's Mount Sinai Medical Center.

UPDATED: Histogenics files for IPO, as Autogenomics refiles again

Implantable tissue repair player Histogenics has filed for an initial public offering to raise up to $65 million. The financing is to fund an ongoing Phase III trial for its NeoCart, an implant to repair knee cartilage damage. Meanwhile, Molecular diagnostics company AutoGenomics is hoping the third time's the charm with its IPO filing for up to $60 million.

Stanford researcher creating a novel device to study pain

Academics hope to enhance a new mouse model created to better understand how pain is transmitted in the body. Ada Poon, an assistant professor of electrical engineering at Stanford University, is working as part of a team to build a wireless device that incorporates existing optogenetics research.

EU halts distribution of GI Dynamics obesity device

The European Union suspended shipments of EndoBarrier, an obesity device from GI Dynamics, for reasons undisclosed by the company. GI Dynamics said the situation is temporary and does not apply to product already in the hands of hospitals and distributors.

Becton plans on $9.1B bridge loan to finance deal with CareFusion

Becton Dickinson plans to finance its acquisition of CareFusion with a $9.1 billion bridge loan, joining the ranks of other med tech outfits which have recently turned to loans for pending M&A deals.

FDA Commissioner addresses approval times, global competitiveness at AdvaMed

FDA Commissioner Margaret Hamburg devoted a large part of her luncheon remarks at the annual AdvaMed MedTech Conference in Chicago to boosting the American device industry's global competitiveness.

At least $200M paid to docs by medical device industry

The federal Open Payments database launched by the U.S.Health and Human Services Dept. announced that the medical device industry paid doctors at least $200 million last year. The database is taking the heat, however, for being generally inaccurate, incomplete and difficult to navigate

Preview: Boston Scientific's Watchman goes before third FDA panel

The long slog toward approval for Boston Scientific's Watchman implant continues today when it goes before a FDA advisory panel for a third time.

Med tech deal value up 363% in first half, with megadeals still pending

A recent report by Evaluate MedTech released at the annual AdvaMed med tech conference in Chicago found that M&A deal value in the med tech sector grew by 363% year over year in the first half of 2014 to $30 billion.

Intel, GE and Cigna expand remote care program for heart failure patients

A pilot program to remotely monitor blood pressure and weight for congestive heart failure patients is being expanded. The program shows how patients and healthcare providers can work together via technology to reduce hospital readmission.

Researchers develop a test for newly identified heart and gut disease

History and science have joined forces. Canadian researchers have discovered and identified a heart and gut disease caused by a genetic mutation that can be traced back to the 12th century Vikings. 

NanoString teams up with Brigham and Women's Hospital for cancer Dx development

NanoString Technologies is teaming up with Brigham and Women's Hospital to study genomic biomarkers and develop diagnostic tests for cancer, furthering the company's plans for accelerated growth.

Unilife inks 15-year deal with Sanofi for wearable injectors

Unilife, the injectable technology provider, has inked a deal with Sanofi to be the French drugmaker's sole provider of cartridge-based wearable injectors for the next 15 years.

GE promotes biz dev exec to head healthcare

GE has appointed John Flannery as the president and CEO of GE Healthcare. He was previously the SVP of business development at the company. The move comes after the healthcare division shrank a bit during the first half.

Optos, NHS and academia in $16M partnership for eye disease diagnostic

Medical retinal imaging player Optos, the U.K. National Health Service and academics will participate in a £10 million ($16 million) collaboration to enable earlier detection of eye diseases that threaten vision.

Researchers identify blood biomarker to predict diabetes risk

Scientists have discovered a blood biomarker useful in identifying patients at risk for developing diabetes.

Health 'wearables' to transition to 'invisibles'?

Wearble health monitors might soon become a thing of the past--replaced by science fiction-sounding "invisibles." Futuristic implantable microchips are shaping up to be the cutting-edge way to monitor health. The idea is to make digital health monitoring a little less all-consuming.

Pain-management outfit Nevro heads to market with plans for up to $115M IPO

Amid growing competition in the neuromodulation field, California devicemaker Nevro filed plans for an initial public offering valued at up to $115 million to ramp up development of its innovative pain-management implant.