American College of Cardiology Meeting coming up next weekend.
USA
FDA Issues Guidance On TriVascular Ovation EndoGraft For Patients With Small Access Vessels And Small Aortic Anatomy
After granting approval for TriVascular to sell its Ovation Endograft in USA under Humanitarian Exemption, FDA now issues guidance for consumers.
AtriClip Stroke Safety and Feasibility Trial Gains FDA Approval
AtriCure has gained FDA’s blessing to commence a study into the impact of its AtriClip Left Atrial Appendage exclusion device on stroke prevention.
Retrospective Data Analysis Suggests Clinical and Economic Advantages Of VATS vs Open Wedge Resection
Ethicon-Endo-supported retrospective data study says VATS is cheaper and better than open wedge resection.
When Is An App A Medical Device?
Our pages are filling up with medical applications for smartphone/tablet technology, but the regulatory status of many new potential products remains unresolved.
Ex-Orthofix Man Joins Small Bone Innovations As President and CEO
Small Bone Innovations has a new President and CEO in the form of ex Orthofix division president Michael Simpson.
Available In EU Since 2004, First US Implant Of Sorin’s Stentless Pericardial Aortic Valve
Eight years after first European implantation Sorin’s Freedom Solo stentless pericardial aortic valve sees its first US patient.
Cryolife Breaks Quarterly Financials Record
Despite losing Hemostase revenue, Cryolife has reported record Q4 and significant annual revenue growth, giving it optimistic outlook for the near term as it enacts global strategic initiatives.
Proton Beam For Prostate Cancer: Study Says Lack Of Evidence Doesn’t Reduce Demand
Expensive Proton Beam therapy availability is limited this side of the pond. For once we don’t advocate speeding adoption, but a lack of evidence doesn’t seem to have slowed demand for its use as a prostate treatment in USA.
FDA Clears Resolute Integrity™ DES For Coronary Artery Disease Including Diabetes Indication
Medtronic Inc’s Resolute Integrity™ Drug-Eluting Stent for treating coronary artery disease has been approved by the FDA, after studies showed consistent clinical performance among a wide range of patients, including individuals with diabetes.
“Microrocket” Powered By Stomach Acid
Fiendishly clever scientists from San Diego have described a microrocket, which would exploit low pH conditions to elicit drive from a chemical reaction. Suggested applications on a postcard please.
Heart Attack Grill Proves Eponymous
It’s a great story unless you’re the victim. We’ve known curry houses which induce “illness”, but this takes the cake.
Stryker’s Wingspan: A Regulatory Conundrum For FDA?
In short Stryker’s brain stent has been used in USA since 2005 on a Humanitarian Device Exemption (HDE) basis and … continue reading “Stryker’s Wingspan: A Regulatory Conundrum For FDA?”
Biocompatibility Screening Test Uses Zebrafish Embryos
A new test called the ZET™ medical device polymer biocompatibility screening test, utilises Zebrafish to screen plastics, composites, and polymers for toxicity. Not sure how they react, but presumably it ain’t good.
US Medical Devices Tax Will Be Passed On To Customers
Quelle Surprise. US manufacturers admit they’ll put prices up to recoup 2.3% sales tax levy.
Hackers Helping Defibrillator Patient Unlock “Unavailable” Implant Data
Hackers may be able to unlock data from implantable defibrillators.