Medical Device Industry News | Qmed

Click here...

Medical Device Industry News

Boston Sci Completes IntellaTip MiFi XP Ablation Catheter Trial

Boston Scientific (Natick, MA) completed a human trial of its IntellaTip MiFi XP ablation catheter. The device is designed for the treatment of cardiac arrhythmia. The company hopes that the 10 patient first-in-human trial will help spur the development of future ablation catheters.
Boston Sci, Medtronic Duke It Out over CRT-D Market

In the past week, two medtech giants butted heads in an advertising battle for consumers. After Medtronic (Minneapolis, MN) launched its new cardiac resynchronization therapy device, Boston Scientific (Natick, MA) sent advertising materials to physicians touting the benefits of their products. While sales of cardiac rhythm devices have been on the decline, the remaining industry players are staging a fierce battle for the hearts and wallets of consumers.
OEMs Offer Medical Device Tax 101 to Employees

For the past year, medical device manufacturers have warned of the potential ramifications of the 2.3% medical device tax, a part of the Affordable Care Act. In the latest effort to repeal the federal excise tax, some medical device companies are educating their employees on how the tax could impact them.
Sedasys Lands PMA for Sedasys Anesthesia System

J&J subsidiary Sedasys (Cincinnati, OH) received premarket approval from FDA regulators for Sedasys, a computer-assisted personalized sedation (CAPS) system. The system is designed for healthy patients undergoing low-risk esophagogastroduodenoscopy and colonoscopy procedures.
Covidien Edges Toward Pharmaceutical-Free Future

Covidien (Mansfield, MA) is moving closer to launching its pharmaceutical spinoff on June 28. On that date, the company will shed Mallinckrodt to pursue a future free of all pharmaceuticals.
India Cuts Reimbursement Rates for Stents

Stent manufacturers with a presence in India are facing some bad news. In February, India decided to cut reimbursement rates for drug-eluting stents.
Florida Becoming Hospitable for Medtech Manufacturers

While Florida may not be home to many of the medical device giants, the Sunshine State is becoming a very hospitable environment for device manufacturers. At the Florida Medical Manufacturers Consortium, industry players celebrated a recently-passed sales tax exemption for certain types of manufacturing equipment.
Medtronic Receives FDA Approval for Evera and Viva Cardiac Implants

Medtronic (Minneapolis, MN) received FDA approval for its Evera and Viva next-generation cardiac implants. Evera is a cardioverter-defibrillator that features the company’s proprietary SmartShock technology. SmartShock delivers inappropriate shocks at a rate of two percent after 12 months. This rate is significantly lower than other similar devices.
Thoratec Shares Drop Following Lackluster Q1

Thoratec Corporation (Pleasanton, CA) released a less-than-stellar first quarter earnings report. Following its Q1 earnings release, shares of Thoratec dropped from $36.50 on Friday to $32.87 on Monday morning.
New Brain Implant Predicts Epilepsy Seizures

A specialized implant by NeuroVista (Seattle, WA) may hold promise as a tool for predicting epilepsy seizures in drug-resistant adults. In a proof-of-concept study published in The Lancet Neurology, researchers provided further details on how EEG data can be interpreted to predict an individual’s risk of epilepsy seizures.

Click here...