News

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.

First head-to-head trial finds Edwards' TAVR superior to Medtronic's

Edwards Lifesciences' Sapien XT beat out Medtronic's CoreValve in the first head-to-head comparison of the two firms' competing transcatheter aortic valve replacements (TAVR). This small trial won't be the last word, but it's seen as a weapon in Edwards' market arsenal versus its rival in a market estimated at $3 billion a year.

In a regulatory overhaul, Chinese authorities pass new rules governing medical devices

Medical device makers will soon face stricter regulation in China, as lawmakers passed new rules governing sales and manufacturing of medical equipment. The rules provide a major overhaul to decade-old legislation and increase punishment for the most serious corporate malpractice violations, Reuters reported.

J&J will sell Ortho Clinical Diagnostics to Carlyle for $4B plus

Johnson & Johnson has formally accepted the Carlyle Group's $4 billion-plus bid to snatch up its Ortho Clinical Diagnostics arm, more than two months after announcing the proposed transaction.

Abbott has won U.S. approval for the peripheral-artery-disease stent it bought last year

Abbott announced on Friday that its Supera Peripheral Stent System has got the FDA's approval to treat blocked blood vessels in the upper leg caused by peripheral artery disease.

Medtronic commits to renal denervation as company details disappointing trial results

Medtronic pledged to plow ahead at some point with a new renal denervation trial, even as details of the company's failed U.S. pivotal study released March 29 revealed that the treatment for drug-resistant hypertension worked no better than a sham procedure.

Biotronik wins CE mark for new pacers that instantly broadcast patient problems to doctors

Biotronik has a CE mark in hand for its new Eluna pacemakers, made with MRI-compatible technology and other advances designed to help them stand out in an already-crowded, stagnant market.

OrbusNeich wraps enrollment in a post-marketing registry for its dual-therapy stent

OrbusNeich said it has wrapped up enrollment in a 1,000 patient post-marketing registry to evaluate its innovative Combo dual-therapy stent in real-world conditions over the next few years.

NeuroSigma brings on two Amgen execs to bolster its finance team

Two Amgen executives are heading to devicemaker NeuroSigma to join the finance team there as the company gears up for commercialization of its big product. NeuroSigma, which specializes in devices for neurological and neuropsychiatric disorders, appointed Carl Adams to be its chief financial officer and Craig Rostamian as its vice president of finance, overseeing planning and analysis, according to a company release.

Exact Sciences wins unanimous FDA panel approval for its colon cancer Dx

Exact Sciences won unanimous FDA committee approval for its stool-based cancer diagnostic, moving the company one step closer to receiving full regulatory clearance for the test.

In Ohio, Steris slashes jobs and plans to close a plant

Steris is cutting back. The Ohio maker of surgical, critical care and infection prevention med tech said it will shut down an Ohio plant and slash 150 jobs in a move expected to save about $10 million annually.

Baxter yesterday, today Smith & Nephew? Talk of a 3-way split

The day after Baxter announced it will split its biopharma and medical products, an analyst is calling for U.K. devicemaker Smith & Nephew to follow suit.

Medtronic launches a massive trial that could widen the use of ICDs in emerging markets

Medtronic said it has begun enrollment of what will be a 4,800-patient clinical trial designed to better identify patients at major risk in developing countries for sudden cardiac arrest.

Japan's regulators OK Accuray's latest robotic radiosurgery system

California's Accuray snagged Japanese regulatory approval for a new iteration of its CyberKnife robotic full-body radiosurgery system--a market known for its robust demand for med tech products and services.

Baxter plans to divide itself into two separate companies

Baxter International plans to split itself into two separate companies, one focused on medical products and the other centered on biopharmaceuticals.

J&J's Ethicon division pays $11M to resolve a vaginal mesh case

It's bad news for Johnson and Johnson's Ethicon division in its ongoing vaginal mesh saga: The company paid out $11.1 million to settle one of the first of many cases to go to court over its transvaginal mesh products, Lawyers and Settlements reported.

Crucial EU compact vote on U.S.-style device approval system raises industry concern

With less than a week before Members of the European Parliament vote on a proposal that would establish a tougher U.S.-style approval system for medical device implants, there remains a wide chasm of concern between member states as the industry grumbles that a new layer of red tape will be added.

 

Named after 'Terminator,' Cyberdyne has a promising start

Cyberdyne, a Japanese developer of medical robot exoskeletons for rehabilitation and elder care, more than doubled in its first day of trading on the Tokyo Stock Exchange's Mothers market.