Boston Scientific is facing more bad news in its ongoing vaginal mesh saga, as a federal judge rejected the company's bid to toss out claims for damages in one of its more than 15,000 product liability suits.
Major Western device and medical technology firms launched Asia Pacific Medical Technology Association, or APACMed, pledging the association would unite a fragmented effort to work with regulators across a region that is both lucrative and frustrating on issues ranging from import rules to public tender guidelines.
Boston Scientific played up a data registry study in the Journal of the American College of Cardiology demonstrating the safety of its subcutaneous implantable defibrillator, which is the only device of its kind without leads that come into direct contact with the heart.
Boston Scientific enrolled the first patient in its renal denervation trial as the quest to prove the procedure's efficacy at lowering hypertension continues in the wake of the Medtronic's disastrous SYMPLICITY trial results, from which the field is still recovering.
Boston Scientific has partnered with Frankenman Medical Equipment to develop and manufacture products in China for that market. The pair also plans to jointly commercialize some products in China. The deal plays up Boston Scientific's strengths within its endoscopy group, which has struggled to keep pace with sales growth in the larger company.
Boston Scientific added to an existing strength in endoscopy by acquiring Xlumena for up to $75 million plus undisclosed sales milestones.
Boston Scientific is initiating a recall of some of its biliary drainage catheters after 11 reports of device fragmentation, according to the FDA's recall database. The recall is labeled Class II, meaning the device "may cause temporary or medically reversible adverse health consequences."
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.