In a show of force, the Department of Justice just announced two fines against providers for healthcare fraud under the False Claims Act totaling more than $10 million. The news coincided with release of an annual report on healthcare fraud, which claims that the feds recovered $3.3 billion in fiscal year 2014.
A California-based Boston Scientific company was slapped with a $50 million gender discrimination suit from a former manager and a current executive who claim the devicemaker unfairly favors its male employees by paying them higher salaries and assigning them to more profitable territories.
Boston Scientific announced that it has received FDA and CE-mark approval to launch the next generation of its subcutaneous implantable defibrillator system, which is implanted under the skin and does not have wires that come into contact with the heart.
The catheter-based insertion of one of the latest generation of drug-coated stents is just as effective as bypass surgery in treating coronary artery disease, according to a study in the latest issue of the New England Journal of Medicine. That was not the case with the prior generations of bare metal or first-generation drug-eluting stents.
Boston Scientific finally won FDA approval for its stroke-fighting Watchman device after setbacks or rejections in 2010 and 2014. The device was approved for patients with an appropriate rationale to seek a nonpharmacologic alternative to the blood thinner warfarin. The FDA's blessing follows a multiyear clinical trial of 2,400 patients.
The medical device tax is costing the med tech industry money--and so is lobbying to get rid of it.
Boston Scientific advised physicians about a particular pacemaker in 2005--but then declined to pay the bills for those surgeries that it subsequently received from German health insurers. An EU court ruled on March 5 that the company is liable for those costs, according to Reuters.
During the continued wave of life science M&A, companies are seeking to focus on core competencies. Once again, this trend has resulted in Boston Scientific snatching the medical device assets of a pharma company, this time from Endo International.
Boston Scientific touted its new cleared endoscopic SpyGlass DS Direct Visualization System enabling direct visualization of the biliary tree and pancreatic ducts. With the FDA's 510(k) clearance now in hand, the device can hit the market.
Boston Scientific sat out most rounds of med tech M&A the past few years, but the device giant might be charting a different course in 2015. The company is reportedly close to buying Endo International's AMS medical device unit in a deal estimated at $2 billion.