The FDA granted 510(k) clearance to Abbott’s (NYSE:ABT) Freestyle glucose test strip for use with Insulet’s (NSDQ:PODD) OmniPod insulin pump.
Abbott
New Conceptus CEO expects boost from ACA | Wall Street Beat
The Affordable Care Act’s provision covering contraception could be an "inflection point" for Conceptus (NSDQ:CPTS) and its Essure female sterilization system, new CEO Keith Grossman told Leering Swann analysts last month.
MassDevice Q&A: James Mazzo, Abbott Medical Optics
You don’t get more dialed-in to the device industry than James Mazzo, and you definitely don’t get busier.
In addition to his duties as senior VP of Abbott Medical Optics Inc., an ophthalmic company he spun out of Allergan (NYSE:AGN) and then sold to health care giant Abbott (NYSE:ABT) in 2009, Mazzo has been the chairman of the Advanced Medical Technology Association, or AdvaMed, for the past two years.
Conceptus CFO reveals 2011 EBIDTA expectations | Wall Street Beat
Abbott launches trial for Esprit vascular disease treatment
Abbott (NYSE:ABT) launched a European clinical trial for its Esprit drug-eluting bioresorbable vascular scaffold to treat leg pain associated with peripheral artery disease.
The Esprit drug eluting BVS is designed to treat blockages in the superficial femoral arteries and iliac arteries that cause leg pain in patients while walking.
Brown ranks high with med-tech makers
Sen. Scott Brown (R-Mass.), a vocal advocate for the medical device industry, has collected thousands in individual donations from med-tech executives and industry political action committees during the 2011-2012 campaign, federal documents show.
Between January and October, Brown received more than $42,000 in PAC donations and individual contributions from medical device groups and executives as he campaigned for re-election.
FDA requires BSX to include stent “shrinkage” risk in Promus Element label
Boston Scientific Corp. (NYSE:BSX) must include the potential for stent "shrinkage" in the labeling for its newly cleared Promus Element drug-eluting stent.
The decision comes as concerns mount that certain thinner, more flexible next-generation stents may be prone to crumpling after deployment, creating clots in blood vessels that may lead to heart attack.
Abiomed announces new Impella device, plan for Japan | Wall Street Beat
Amid celebrating the first human use of its Symphony implantable heart pump for chronic heart failure patients, Abiomed (NSDQ:ABMD) unveiled a new ventricular assist device for its flagship Impella line of heart pumps.
Announced at the company’s annual investors’ day in New York, the new device is slated to hit the market some time next summer. Abiomed also has its sights set on entering the Japanese market in 2013.
Olympus restates books, takes $1.1B hit | Wall Street Beat
Olympus Corp.’s (TYO:7733) re-stated finances for the past 5 years include a $1.1 billion hit from its 13-year scheme to hide investment losses with specious M&A consulting fees.
The endoscopy giant made the filings with Japanese regulators after being caught red-handed cooking its books to hide the fees, just avoiding a de-listing from the Tokyo stock exchange but fueling rumors that it will need to merge, sell a division or two or raise some cash to keep itself alive.
Chinese hackers hit Boston Scientific
Med-tech titan Boston Scientific (NYSE:BSX) was one of 760 companies hit by Chinese cyber attacks that also targeted U.S. government agencies, research universities and Internet providers.
It’s not clear whether the Natick, Mass.-based medical device maker lost any sensitive information in the attack.
Med-tech stocks rebound after Medicare jolt | Wall Street Beat
Wall Street investors rebounded from the jolt delivered by the Centers for Medicare & Medicaid Services last week, regaining most of the value lost after the agency announced stiffer rules for its coverage of some medical procedures.
The new pre-reimbursement review program will ask doctors to provide up-front justification for certain medical equipment and types of claims. Set to launch in 11 states next month, it will flip the reimbursement system from the agency’s existing “pay-and-chase” method of looking for improper payments after they’ve already been made.