Medical Devices Today

Medtronic Warned By FDA To Fix Reporting, Complaint Problems In Colo.

 

Medtronic Study Shows Diabetes Device Better Than Usual Therapy

Baxter Warned By FDA Over Procedural Lapses With Dialysis Devices

Zimmer Wins Procedural Victory In Patent Suit Filed By MedIdea

Alcon IDC Must Vote On Novartis Bid Ahead Of Board, Adviser Says

American Medical Gets FDA Clearance For Female SUI Device

Zimmer, Biomet, Cook Lead Indiana Device Maker Fight Against New Tax

Abbott Gets FDA Approval For Freestyle Diabetes Testing Strips

Boston Sci, Medtronic, St. Jude May Face Loss Of Favored Sales Targets

Boston Scientific Cleared For Trials Of Rechargeable SCS Device

Boston Sci Agrees To $55 Million Investment In Quincy, Mass., Facilities

Covidien Launches First Of Surgical Staplers With New Technology

Bayer Alerts Rhode Island Officials To Unapproved Versions Of Its IUD

Boston Sci Rearranges Credit To Pay Off Abbott, Other Debts

Smith & Nephew Loses At Home In Patent Case Brought By KCI Of U.S.

VC Firms Seek New FDA Review Path, User Fee For "Novel" Devices

Article preview from "The Gray Sheet" - June 28, 2010

The National Venture Capital Association is in discussions with senior CDRH officials about establishing a separate, more efficient pre-market review pathway for especially novel devices, supported by a supplemental user fee.

CDRH Pre-Market Reform Proposals Expected Within Weeks

Article preview from "The Gray Sheet" - June 28, 2010

The FDA device center's upcoming proposals for reforming its pre-market policies will directly address widespread industry concern that reviews are increasingly unpredictable and opaque, CDRH Director Jeff Shuren told an industry audience last week.

FDA And CMS Agree To Share Data Routinely In Step Toward Parallel Reviews

Article preview from "The Gray Sheet" - June 28, 2010

Routine sharing of data between FDA and CMS will be possible for the first time under a June 23 memorandum of understanding that could serve as a first step toward parallel reviews for marketing approval and Medicare coverage.

Pay Close Attention To Equipment Calibration Certificates, FDA Says

Article preview from "The Silver Sheet" - June, 2010

Devices manufactured with improperly calibrated equipment can pose a hidden risk for companies, FDA says. The agency urges firms to investigate if they discover that a product made with out-of-specification equipment has gone to market. Further, many device firms are not adequately reviewing the work of third-parties that calibrate their manufacturing equipment.

Building Interventional Gynecology

Article preview from Start-Up - June, 2010

Once a sluggish category for clinical innovation, gynecology is drawing new venture-backed companies eager to build upon the lead created by first-generation companies operating in minimally-invasive endometrial ablation and female sterilization. First generation companies had the difficult task of creating paths to early adopters of minimally invasive procedures. These now exist, and the clinical specialty appears to be also evolving in ways that encourage the growth of in-office procedures.

Rule On Pediatric Device Data Oversteps FDA Authority - AdvaMed

Article preview from "The Gray Sheet" - June 21, 2010

An FDA rule requiring pre-market device submissions to include additional data on pediatric patients oversteps FDA's statutory authority, trade group AdvaMed says.

FDA Aims To Finalize Framework For Lab-Developed Tests In Near Term

Article preview from "The Gray Sheet" - June 21, 2010

FDA could have a final framework in place for overseeing a greatly expanded range of laboratory test services within months of a public meeting scheduled for July, according to agency officials.

EuroPCR Highlights: TAVI Set to Continue Rampant Growth

Article preview from Medtech Insight - June, 2010

With innovation as the theme of this year's EuroPCR meeting, emerging technology sessions and innovation presentations sparked lively discussions. While drug-eluting stents remained a key interest area, transcatheter aortic heart valve implantation sessions drew the largest crowds.

IOM Committee Questions Adequacy Of Compliance Tools In 510(k) Program

Article preview from "The Gray Sheet" - June 21, 2010

Questions about the adequacy of FDA's compliance and surveillance tools for 510(k) products were among those raised by an Institute of Medicine task force during its second public meeting to evaluate the pre-market clearance program.