News

Roche snags diagnostics outfit IQuum in $450M deal

Roche is beefing up its point-of-care molecular diagnostics offerings, signing a deal to acquire Marlborough, MA-based IQuum for $275 million up front and up to $175 million in milestone-based payments.

Edwards Lifesciences wins CE mark for aortic valve system

Edwards Lifesciences won a CE mark for its innovative aortic valve system. European approval for the device comes at a critical moment for the company, as it attempts to strengthen its hold on foreign markets and stay a step ahead of its competition.

CyVek immunoassay technology gets $10M investment

CyVec and its immunoassay technology got a $10 million investment shot in the arm from Minneapolis-based Bio-Techne with an additional promise to acquire the company in the future if certain conditions are met.

TriVascular Technologies to target $13-$15 per share as IPO terms become clear

TriVascular Techologies is setting the terms for its planned IPO, and the California maker of stent grafts to treat abdominal aortic aneurysms aims for a fairly robust debut.

Jury partially faults J&J in another vaginal mesh trial verdict

Johnson & Johnson's Ethicon arm has been ordered to pay $1.2 million in damages in a trial alleging it produced faulty vaginal mesh that was implanted into a 64-year-old woman.

Holaira brings in $42M Series D to test COPD lung denervation treatment tool

Minnesota startup Holaira attracted $42 million in new financing that will back a formal human clinical trial for a lung denervation treatment that addresses chronic obstructive pulmonary disease.

RefleXion raises $11.6M in Series A funding round

RefleXion Medical raised $11.6 million in a Series A financing round for its biologically guided radiation system for cancer treatment.

 

Vapotherm seals $24M financing round, elects new board member

Vapotherm, a maker of respiratory therapy devices, disclosed this week it finalized a $24 million round of funding from a consortium of 8 investors and expanded its board.

The U.K.'s Cytox attracts $2.5M in new investment to pursue Alzheimer's biomarker work

U.K. diagnostics developer Cytox raised nearly $2.5 million in new funding to help expand work on the development of a viable Alzheimer's biomarker.

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.