“The Gray Sheet” from Elsevier Business Intelligence

New Metrics For Clinical Trial Oversight Floated By CDRH Entrepreneurs In Residence

rebecca.kern@elsevier.com — Mon, 20 May 2013 00:03:00 -0400

Variability runs high in FDA’s process for approving new device trials, but the agency is open to recommendations for improvements coming out of its entrepreneurs-in-residence program, says Chip Hance, a former Abbott executive participating in the program.

99 Cent Urinalysis App Raises Questions About mHealth Standards

d.tahir@elsevier.com — Mon, 20 May 2013 00:02:00 -0400

The uChek urinalysis app made a splash last month with its launch in the iTunes App Store, but it did not appear to follow the same pre-market requirements as analogous conventional urine analyzers, contributing to questions about mobile health regulatory oversight and innovation.

CardioFocus Piles Up Data On HeartLight Laser AF Ablation Catheter

re.miller@elsevier.com — Mon, 20 May 2013 00:01:00 -0400

In addition to the more than 1,300 ablation procedures completed outside the U.S. with the unique visually guided ablation catheter, the venture-backed company is conducting an IDE trial in 21 U.S. centers, which it expects to complete in 2014.

FDA 510(k) Clearances: April 2013

Mon, 20 May 2013 00:00:00 -0400

The agency cleared 248 devices in April.

IPAB’s Tough Road: Republicans Opt Not To Help Find Members

s.steinke@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

House Speaker Boehner and Senate Majority Leader McConnell “respectfully decline” the president’s request to submit names of individuals to serve on the Medicare Independent Payment Advisory Board.

Dual Chamber ICDs Show No Benefit Over Single-Chamber ICDs In Primary Prevention

re.miller@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

Results of a study published in the May 15 issue of the Journal of the American Medical Association found that dual-chamber implantable cardioverter defibrillators were associated with more complications than single-chamber devices in primary-prevention ICD patients with similar rates of death and hospital readmissions.

People In Brief

Mon, 20 May 2013 00:00:00 -0400

Edwards Lifesciences chief financial officer to retire. Trice Orthopedics raises $3 million, names president.

Chinese Researchers Develop Diagnostic With High Specificity To New Bird Flu Virus

s.darcey@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

University of Hong Kong researchers say they have developed a new test for rapid identification of the H7N9 virus, which has killed more than 30 people in China this spring and triggered concerns about a pandemic.

C.R. Bard Pays $48 Million To Settle Brachytherapy False Claims Act Allegations

s.darcey@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

The settlement addresses allegations by the Justice Department that the company provided kickbacks to Medicare customers and physicians from 1998 to 2006 to purchase brachytherapy seeds used to treat prostate cancer.

NICE In Brief

Mon, 20 May 2013 00:00:00 -0400

The U.K.’s National Institute for Health and Care Excellence OK’s subcutaneous ICD implantation, but recommends outcomes data collection. Vertebroplasty and kyphoplasty win recommendation in technology appraisal guidance.

Draft Guidance Addresses Company Requests For Rationale Of FDA Decisions

m.houghton@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

The document offers FDA’s interpretation of the terms “substantive summary” and “significant decisions,” both of which appear in new statutory provisions related to the longstanding process for manufacturers to appeal an agency decision.

FDA’s Potential Black Hole: House Investigates Departure Of Acting Head Of Medical Products Office

d.gingery@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

Energy and Commerce Committee letter states public information discrepancies raised questions about Leona Brenner-Gati’s status and “the circumstances surrounding her resignation.”

Trolls Amassing “War Chests” Of Device Patents, Industry Exec Warns House Panel

s.darcey@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

Incubator executive Jeff Grainger of The Foundry LLC, tells House Small Business Committee May 15 that the device industry should be alert to “patent trolls” collecting intellectual property and amassing war chests of device-related patents in anticipation of filing future patent suits.

News In Brief

Mon, 20 May 2013 00:00:00 -0400

Tavenner confirmed as CMS chief. DePuy phases out metal hips.

New Products In Brief

Mon, 20 May 2013 00:00:00 -0400

New cancer companion diagnostic approved. Biotronik’s Ilesto 7 ICD and CRT-D earns FDA approval.

Research In Brief

re.miller@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

GE’s Mavric SL magnetic resonance technology may help find problems with hip implants. Zoll’s Lifevest wearable defibrillator performs well in registry.

SCAI To Unveil New Diagnostic Cath Lab Calculator

l.radick@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

Interventional cardiology professional society to release diagnostic cath calculator as well as updates to the existing app that provides access to coronary revascularization appropriate use criteria and guidelines.

Boston Scientific Subsidiaries Barred From Selling Multiple Drug-Eluting Stent Lines In Germany

d.tahir@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

A German court had previously blocked Boston Scientific’s German subsidiary from selling drug-eluting stents affected by OrbusNeich’s patent suit; the new injunction closes a loophole, preventing any Boston Scientific subsidiary from selling the devices in Germany.

FDA Recalls List – May 8, 2013

Mon, 20 May 2013 00:00:00 -0400

The agency’s May 8 enforcement report includes eight class I recalls, including actions from Medtronic, Maquet Cardiovascular and Hospira

FDA Warning Letters Released The Week Of May 13

Mon, 20 May 2013 00:00:00 -0400

Agency issues warnings to device manufacturers in Switzerland, Germany, Italy and the U.S.

Minimal Correlation To Device Costs In CMS-Released Hospital Charge Data

rebecca.kern@elsevier.com — Mon, 13 May 2013 00:03:00 -0400

An unprecedented release of data by the agency highlights vast differences across the country between what hospitals charge for different procedures, but the disparities by and large don’t reflect actual hospital costs.

Live Transmission Of TAVR Found Safe, And More From Annual SCAI Conference

l.radick@elsevier.com — Mon, 13 May 2013 00:02:00 -0400

Interventional cardiologists presented new data at the annual meeting of The Society for Cardiovascular Angiography and Interventions supporting the safe use of live video transmission of transcatheter aortic valve replacement cases, and results from other late-breaking clinical trials.

Seize China Opportunity Quickly, Morgan Stanley Analysts Urge

d.tahir@elsevier.com — Mon, 13 May 2013 00:01:00 -0400

“Barriers to entry are higher than some investors appreciate, and fast followers may be on a path to permanent impairment,” industry analysts note in a recent market research report on the China opportunity for device manufacturers.

Medtronic Claims Clinical, Cost Advantages For Just-Launched Viva CRT-D

re.miller@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

Viva is the first of Medtronic’s U.S. CRT-Ds to incorporate the proprietary AdaptivCRT algorithm designed to more readily adapt to a patient’s condition and optimize therapy.

FDA Proposes 510(k) Requirements For Tanning Beds

rebecca.kern@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

The agency issued a proposed order reclassifying tanning beds from class I to class II with 510(k) requirements, and is proposing strict warnings against use in children under age 18.

One-Third of Surveyed Device Firms Expect Increased Customer Base From ACA

s.darcey@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

The survey of 123 device executives sponsored by MassMEDIC probed the impact of the Affordable Care Act. Of the 33 percent who expect an increase in patient customer base from the insurance expansion, about one-quarter said it would be enough to counter the negative impact of the device excise tax.

Tavenner’s Confirmation For CMS One Step Closer As Harkin Lifts Hold

c.kelly@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

Sen. Harkin said he is lifting his hold on a Senate vote on Marilyn Tavenner’s nomination to head CMS because he recognizes the agency needs a permanent leader as it faces the challenges of implementing the Affordable Care Act’s coverage expansion provisions.

Reimbursement In Brief

Mon, 13 May 2013 00:00:00 -0400

HHS Office of Inspector General says Illinois should reduce Medicaid rates for diabetes test strips, and that Medicare is paying so-called G modifier claims inappropriately in reports last week. More reimbursement news.

People In Brief

Mon, 13 May 2013 00:00:00 -0400

Clinical Innovations appoints CEO, FDA gains a deputy commissioner, and Covidien names a new corporate communications executive. More people briefs.

Qualcomm Life Acquires HealthyCircles, Targeting 2net Platform At ACOs

d.tahir@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

The acquisition of the care-coordination software firm supports Qualcomm Life’s strategy to target accountable care organizations with its platform for wirelessly linking medical devices.

Industry Largely Supports FDA’s New Proposal On Pediatric Data Submission

rebecca.kern@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

Device companies are generally happy with FDA’s rewrite of a rule requiring information on pediatric populations suffering from conditions their devices are intended to treat. The American Academy of Pediatrics is less pleased.

BRUISE CONTROL: ICD, Pacemaker Surgery Can Be Safe On Anticoagulantion Therapy

re.miller@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

The study was stopped early after it became clear that patients on warfarin receiving a pacemaker or ICD had a reduced rate of device-pocket hematomas compared to those on heparin.

Regulatory News In Brief

Mon, 13 May 2013 00:00:00 -0400

FDA’s Microbiology Devices panel and Dental Products panel to meet this summer. More regulatory news.

News In Brief

Mon, 13 May 2013 00:00:00 -0400

AdvaMed presents CEO survey to FDA. Former ArthoCare exec pleads guilty to securities fraud charges from DOJ.

Sorin Hopes Improving CRT Response Rate Will Lead To Growth In U.S. Market

re.miller@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

The Italian company is set to launch the RESPOND CRT trial of its SonR cardiac resynchronization therapy, which Sorin expects will be an important differentiator that allows the company to compete more aggressively in the U.S. market.

Digital Health In Brief

Mon, 13 May 2013 00:00:00 -0400

mHealth Regulatory Coalition invites EU expansion. Foundation tests digital diagnostic tools in Brazil.

FDA Recalls List – May 1, 2013

Mon, 13 May 2013 00:00:00 -0400

The agency’s May 1 enforcement report includes 20 class II and 2 class II device recall actions.

FDA 510(k) Clearances: April 2013

Mon, 13 May 2013 00:00:00 -0400

The agency cleared 248 devices in April.

FDA Warning Letters Released The Week Of May 6

Mon, 13 May 2013 00:00:00 -0400

Agency issues warnings to device manufacturers in Austria, China, Germany and the U.S.

PROTECT AF Results Show Long-Term Efficacy Of Watchman LAA Closure Device

re.miller@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

Boston Scientific is highlighting a secondary-endpoint analysis showing that the left-atrial appendage closure device reduced all-cause death by 34 percent. The company plans to submit a PMA for the device by the end of the second quarter.

Advanced Imaging Slowdown Significant Factor In Overall Health Spending Deceleration – Study

s.darcey@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

Policymakers have cited the struggling economy as the primary source of the deceleration in overall health care spending, but an advanced imaging slowdown, lower prescription drug spending and several other factors may have combined to play an even more significant role, Harvard economists argue.

FDA Outlines Next Steps For Online Repository And Standard Elements For Device Labeling

l.radick@elsevier.com — Mon, 06 May 2013 00:03:00 -0400

Industry representatives, health care providers, patients and caregivers gathered April 29-30 to discuss CDRH labeling activities and the agency’s ideas for the future.

FCC Simplifies Process To Access Wireless Spectrum For Device Clinical Trials

d.tahir@elsevier.com — Mon, 06 May 2013 00:02:00 -0400

A Federal Communications Commission regulation establishes a medical testing license for health care facilities wishing to host human trials for medical devices with wireless capability.

FDA Reconsiders UDI Direct Marking Requirements For Implants

rebecca.kern@elsevier.com — Mon, 06 May 2013 00:01:00 -0400

An agency official says FDA is reworking the UDI direct part marking requirements for implants and making other changes in the final unique device identification rule, due out in June.

More Specific Device Cost Data May Inform Medicare Inpatient Payments In FY 2014

d.filmore@elsevier.com — Mon, 06 May 2013 00:00:30 -0400

CMS says it is finally ready to start relying on a specific cost-report line that it created five years ago for implantable devices, as well as distinct lines for cardiac catheterizations, CT scans and MRIs established more recently, to calculate hospital inpatient payments. It’s a positive for implantables and a negative for advanced imaging payments.

FDA’s February 2013 Medical Device Approvals

Mon, 06 May 2013 00:00:00 -0400

The agency approved two original PMAs and 79 supplements in February

FDA’s James Valentine Discusses New Patient Network Website

rebecca.kern@elsevier.com — Mon, 06 May 2013 00:00:00 -0400

The goals of the agency’s Patient Network website, which went live in late April, are to educate and to get patients and patient advocates involved in the FDA regulatory process.

CMS Tinkers With Readmissions Policy, Other Quality Initiatives

d.filmore@elsevier.com — Mon, 06 May 2013 00:00:00 -0400

The agency plans to be more selective about which hospital readmissions count toward a potential payment reduction in fiscal year 2014, according to its inpatient payment proposal. CMS also proposes hip and knee replacements as a new category of hospital admission to be included in the readmissions reduction program.

Research In Brief

Mon, 06 May 2013 00:00:00 -0400

Data preview for Heart Rhythm Society conference in Denver this week. More research news.

Panel Supports Allergan’s Juvéderm Voluma XC Dermal Filler, But Beauty In The Eye Of Evaluator

s.darcey@elsevier.com — Mon, 06 May 2013 00:00:00 -0400

FDA General and Plastic Surgery Devices Advisory Panel gives the thumbs up to Allergan’s Juvéderm Voluma XC dermal filler, designed to address overall volume loss in the face that accompanies aging. The product met its endpoints, but there was frequent disagreement between evaluators in assessing the product’s effectiveness.