After granting approval for TriVascular to sell its Ovation Endograft in USA under Humanitarian Exemption, FDA now issues guidance for consumers.
FDA
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.
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.
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.
FDA Slow To Clear Products When EU Data Lacking
New paper compares CE vs FDA and concludes both need a makeover.
Metal-on-Metal: Should FDA Concerns Have Made DePuy Act Sooner Overseas?
A new article in the New York times suggests J&J DePuy were wrong in continuing to sell product overseas after FDA raised concerns. If that happened every time FDA demanded more clinicals we might as well harmonise.
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?”
PIP Scandal Muddies Regulatory Debate
Opinion piece on how the PIP scandal is flushing out a mixed bag of arguments. But at least we’re thinking about the subject.
FDA Allows CE Marked Glue In On “Investigational Device” Basis
Abstract Yet again the CE vs FDA debate is brought into sharp relief with the news that Cohera Medical has … continue reading “FDA Allows CE Marked Glue In On “Investigational Device” Basis”
Sparks Fly At Riata Lead Summit
A sizeable group of clinicians and St Jude representatives have met to discuss the issue of “externalised” Riata implantable defibrillator leads.
Stryker Settles For $15M
Stryker Corporation has announced that it’s Biotech division has reached a settlement with the U.S. Attorney’s Office for the District of Massachusetts, agreeing to pay a non-tax deductible fine of $15 million for one misdemeanour. Thirteen other felony charges will be dismissed.
Depuy Pulls Plug On All Custom Implants Following FDA Warning
FDA warns DePuy about the use of custom device exemption to allegedly supply devices that don’t fit FDA’s definition of custom. DePuy then ceases manufacturing all custom devices.
Hips: Huge Data Analysis Inconclusive
After studying data relating to 3404 hips enrolled in 18 comparative studies and over 830 000 operations in national registries, researchers showed only limited evidence of comparative effectiveness of various hip implant bearing combinations.
FDA Warning Letter To J&J Subsidiary Diabetes Pump Company
It’s all good news for J&J as another of its divisions faces a telling off from FDA.
Covidien Contraindicates Use of Duet TRS™ For Thoracic Surgery And Implements Voluntary Recall.
Covidien has today announced that it is conducting a voluntary recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.
Linx Laparoscopic Anti-Reflux Device Gains FDA Panel Support
Sphincter specialist Torax Medical Inc. has taken a significant step towards FDA approval for its Linx device, designed for treatment of Gastro-Oesophageal-Reflux Disease by gaining the unanimous support of FDA’s 9 member advisory panel.