Concept Medical said yesterday that it received CE Mark approval for three versions of its MagicTouch sirolimus-coated balloons. The MagicTouch PTA for peripheral artery disease, MagicTouch ED for erectile dysfunction and MagicTouch AVF for arterio-venous fistula and graft all received approval in Europe, according to a news release. Get the full story at our sister […]
Georgia to investigate BD medtech sterilization plant
The Georgia Environmental Protection Division (EPD) has opened an investigation into Becton Dickinson’s (NYSE:BDX) medical device sterilization plant in Covington, Ga. following an eight-day leak of the sterilant gas ethylene oxide (EO). The EPD notified BD this week that it was dissatisfied with the company’s reporting of the valve leak that released 54 lbs. of ethylene oxide […]
Judge lambastes Boston Scientific’s slow-rolling ‘shenanigans’ in whistleblower suit
A federal judge in Minnesota this week lambasted Boston Scientific (NYSE:BSX) “shenanigans” in slow-rolling the discovery process in a whistleblower lawsuit lodged over two of its cardiac rhythm management devices, imposing sanctions for the conduct. The lawsuit accused Boston Scientific of defrauding the FDA by not reporting alleged defects in its Cognis cardiac resynchronization therapy defibrillator […]
9 early medical devices that will horrify or amaze you
The movie Frankenstein inspired eight-year-old Earl Bakken to consider how electricity could restore life and health to the human body. Bakken went on to invent the first external cardiac pacemaker and to co-found medtech giant Medtronic in 1949. Bakken’s fascination with the effects of electricity on the human body continued throughout his career, and he amassed a collection of […]
Johnson & Johnson agrees to $117m pelvic mesh settlement with 41 states, DC
Johnson & Johnson (NYSE:JNJ) yesterday agreed to pay $117 million to settle charges of deceptive marketing of its pelvic mesh products with 41 states and the District of Columbia. The states and DC alleged that J&J and subsidiary Ethicon broke state consumer protection laws by misrepresenting the safety and effectiveness of its mesh devices, which […]
Intuitive Surgical gains on Q3 beats
Intuitive Surgical (NSDQ:ISRG) shares gained in pre-market trading today after the robot-assisted surgery pioneer posted third-quarter results that beat expectations for both sales and earnings. Sunnyvale, Calif.-based Intuitive reported profits of $396.8 million, or $3.33 per share, on sales of $1.23 billion for the three months ended Sept. 30, marking a 35.7% bottom-line gain on sales […]
Report: Sanofi is shopping SepraFilm unit to Baxter
Sanofi (NYSE:SNY) is said to be in advanced talks with BAX to sell its Seprafilm surgical products business for up to $400 million. SepraFilm is designed to prevent adhesion after abdominal surgeries. The French drugmaker, which acquired SepraFilm in 2011 when it paid $20.1 billion for Genzyme, wants to close the deal “with the next few […]
Georgia mayor wants BD sterilization plant shuttered for now
The mayor of Covington, Ga. has asked Becton Dickinson (NYSE:BDX) to temporarily shut down a plant there following a weeklong leak of the gas it uses to sterilize medical devices. A letter from Mayor Ronnie Johnston says that independent air quality tests performed for the city from Sept. 17 to Sept. 24 revealed “particularly high levels of […]
AdvaMed asks Trump to back medical device tax repeal
The president & CEO of the nation’s largest medical device lobby asked President Donald Trump to back its effort to repeal the medical device tax enacted as part of Obamacare. The medtech tax, a 2.3% levy on U.S. sales of prescribed medical devices, was in effect from 2013 to 2015 and has been suspended several […]
NIH study: Tandem Diabetes artificial pancreas bests other treatments
A pivotal trial funded by the National Institutes of Health found that an artificial pancreas system from Tandem Diabetes Care (NSDQ:TNDM) was more effective than existing treatments for people with Type 1 diabetes. The Tandem system combines its t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology with a continuous glucose monitor made by DXCM, […]
Controversy erupts over stenting study
Controversy reportedly erupted at a European cardiovascular society conference this week after a prominent cardiologist accused the study’s investigators of manipulating the trial to skew the results. Five-year data from the Excel trial, released last month at the Transcatheter Cardiovascular Therapies conference, showed that percutaneous coronary intervention was as good as coronary artery bypass grafts […]
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