Boston Scientific (NYSE: BSX) has agreed to buy Endochoice Holdings, an Alpharetta, Ga.-based company focused on endoscopy, in a deal valued at about $210 million. Endochoice (NYSE: GI) develops single-use devices, such as resection and retrieval devices, needles, graspers and infection control kits. The company also is a player in pathology services and imaging technologies. Upon the completion of the deal, Endochoice will become part of Marlborough, Mass.-based Boston Scientific's endoscopy business. The companies hope to wrap up the transaction before the end of the year. "The addition of Endochoice products and services to our...

Natus Medical Inc.'s stock (NASDAQ; BABY) slipped 9.73 percent ($4.28) after the company said it expected a revenue shortfall for the third quarter, primarily due to a shipping hold, but also shared plans to buy GN Otometrics from GN Store Nord A/S in a $145 million cash deal. Natus, of Pleasanton, Calif., said the acquisition of Otometrics, which makes hearing diagnostic and balance assessment equipment and has contributed about $110 million in annual revenue to Taastrup, Denmark-based GN, will expand its offering with "very little overlap." The deal is expected to close by the...

Never a dull moment in the world of medical devices and the Food and Drug Administration, is there? Sometimes the FDA is on the march, other times it seems the agency is about to be eclipsed by other forces. Don't be fooled by the picture on the left, though. There is no FDA airline, or any intent by the agency to regulate airlines (none that we know of, anyway) other than the food they serve on board. A case of regulatory leapfrog? Device flight is the term used...

You have to hand it to the cancer lobby. It really has the U.S. federal government wrapped around its little finger. Some will say I'm overstating the case, but is that really a solid argument? Let's examine the evidence. Mortality, economic impact boxes? Not checked First, let's look at overall mortality in the U.S. According to the National Center for Health Statistics, heart disease was responsible for more than 614,000 deaths in 2013, while the various cancers claimed fewer than 592,000 lives. If you add cerebrovascular deaths (more than 133,000) into the...

The urge to go on biggering and biggering and biggering has taken over the med-tech world. Barely a year after Zimmer and Biomet completed a $14 billion merger to become the second largest orthopedic device maker, the company now plans to spend another $1 billion to buy LDR and grow its spine business. Not too long ago a deal this size would have been considered a blockbuster for the medical device industry. But after two years of mega-mergers like Zimmer-Biomet, Medtronic-Covidien ($42.9 billion) and the still-pending $25 billion merger of Abbott and St. Jude Medical, this latest acquisition pales by...

The story coming out of Avinger Inc. isn’t so much that the Redwood City, Calif.-based company significantly lowered guidance for 2016 revenue, but rather it received FDA clearance for an enhanced version of its lumivascular atherectomy system. Analysts sang tunes of praise – almost totally overlooking the firm’s ultra conservative stance on revenue. Consensus had estimates at $38 million, but Avinger gave guidance at between $25 million and $30 million. “The approval of Pantheris is the most important milestone in the company’s [nine-year], history,” said Jason Mills, an analyst with Canaccord Genuity. Analysts are championing Pantheris, as a product...

It took 10 years but Boston Scientific (BSX) may have finally overcome its ill-advised 2006 Guidant acquisition. The company’s shares hit a decade high Wednesday, at one point spiking nearly 12 percent to $22.05 after knocking its first quarter sales out of the park. Listening to the earnings call, the baseball fan in me couldn’t help but draw comparisons between the company’s better-than-expected earnings and what is already a record-setting season for the Chicago Cubs. Sure, it seemed like a stretch at first, but the more I thought about it the more the analogy made sense. After all, the Cubs...

The Windy City really lived up to its name during the course of ACC 2016, didn't it? It was also interesting to hear the recording on the subway stating that gambling is not allowed on the trains. Who knew? ACC 2016 provided a lot of gist for the scribbling class, including some noise about operator volume requirements for TAVR devices. There was also pressure from physicians on FDA to approve the latest generation of devices based on data from other than the classic randomized trial, which in the past may or...

Everyone has heard about the FDA advisory hearing for the Absorb scaffold by Abbott Vascular, but to recap, one of the issues that came up in connection with the trial data for the Absorb was the association between coronary artery vessel size and adverse events such as thrombosis. There was some question of whether intravascular ultrasound (IVUS) would be useful in cutting down on such events, maybe not a bad idea in principal given that the Absorb's struts are much thicker than those found in conventional device struts. But that was just the beginning of the IVUS conversation. Several days...

Now that Abbott Vascular has pulled out a resounding win at an FDA advisory committee for its Absorb bioresorbable scaffold, it's time to ask what the coverage and reimbursement pictures look like. The coverage part looks easy – perhaps easier than it really is – but it may be more helpful to ask who will be first to give the Absorb a look via the reasonable and necessary lens. CPT + MAC = OMG The easy part of the Absorb situation is the diagnostic-related group discussion because it presumably folds neatly...