Medical Devices Today

iPhone App Helps Reduce Door-To-Balloon Times In Cath Lab Patients

Article preview from "The Gray Sheet" - November 29, 2010

The latest version of the Lifenet web-based data network from Physio-Control includes a 510(k)-cleared iPhone application called Lifenet Consult that allows cardiologists to monitor chest-pain patients before they reach the hospital and alert hospital administrators that the cath lab will be needed.

Abbott, Roche, Others Hurry Research For Widespread XMRV Retrovirus

Medtronic’s New Products Seen Key To Countering Cost Of Legal Settlements
Medtronic, Boston Sci Criticized For Not Reporting Doctor-Training Outcomes
Medtronic Plans To Buy Rest Of Ardian, Hypertension Device For $800 Million
Boston Sci, Ethicon Unit, Allergan Led In Reported Device-Maker Gifts
GE, Others Increase Activity In Field Of Home-Health Monitors For Elderly
BD Catheter Lines Subject Of New Questions About Failures In Neonatal Care
Boston Sci To Buy Sadra Medical And Heart Valves For As Much As $386 Million
Boston Sci Wins EU Approval To Market Three Implantable Heart Devices
Medtronic, Biomet, Dentsply Eyed As Possible Buyers For Astra Tech
Medtronic Says Endurant Aortic Aneurysm Stent Passes First Trial
Medtronic Says Frustrated By FDA Delay In Clearing Pacemaker Plant
Medtronic Settles Purchase Of Osteotech, Orthopedic Products
Smith & Nephew Loses Latest Round In Patent Fight With KCI
Wright Medical Settles Labor Dispute With French Workers For $4.5 Million

 

 

Device Firms Weigh Pros And Cons Of FDA-CMS Parallel Review

Article preview from "The Gray Sheet" - November 22, 2010

As FDA and CMS edge closer to a joint program for pre-market review and reimbursement decision-making, device and diagnostic firms are expressing wariness about participating.

FDA Says Mela Sciences Device Needs New Study For Melanoma Detection

Article preview from "The Gray Sheet" - November 17, 2010

Mela Sciences should conduct a new study of its MelaFind melanoma detection system since the current data have not demonstrated "any true additive value" for its intended use, and the device "may potentially cause more harm than good," according to FDA reviewers.

The How And When Of Applying Sequencing To Clinical Diagnostics

Article preview from In-Vivo- September 01, 2010

Gene sequencing instrument providers are currently at the center of a range of corporate activities: acquisition, partnering, financing. As technology innovation continues, costs decrease, and the pace and scope of clinical genomic studies picks up, the notion of sequencing as the foundation for a clinical diagnostics platform is gaining more support. Delivering value to diagnostics customers ultimately may demand that instrument providers move downstream, involving themselves in data analysis and workflow and even test development, to prime the clinical market.

Medtronic Hungry For Acquisitions, Just Not Big Ones, CEO Says

 

AstraZeneca Said To Offer Device Unit For Sale To Raise Cash 
Medtronic, Boston Sci, St. Jude Combo Devices Get Major Study Boost
Medtronic Defib Unit Physio-Control Partners With AirStrip Tech
Boston Sci Study Finds Pre-Set Heart Devices As Good As Customized
Edwards Sapien Heart Valve Shows Improvement Over Standard Therapy
Philips, Other External Defibs Face Closer FDA Review In Wake Of Failures
Genzyme CEO Sells 5.4 Percent Stake In Abiomed While Novartis Target
Medtronic, Almylam To Develop Huntington’s Device With Foundation Help
St. Jude Says Cleared Major U.S. Hurdle In Acquiring AGA Medical
Abbott, Baxter, Medtronic, Others Seen Likely To Pursue M&A Actions
Ethicon Endo-Surgery Gets More Time To Prove Case To FDA Advisors

Welsh Carson Taps Into Spinal Market with K2M Buy

Article preview from Start Up- September 01, 2010

Welsh, Carson, Anderson & Stowe, a long time investor in health care services companies, signaled its intent to invest more deeply in the device sector with the acquisition of a majority position in spinal company K2M Inc.

Automated Patient Surveillance Systems Take Aim at Hospital Infection Control Practice

Article preview from Medtech Insight -October 01, 2010

Pressure to adopt the latest infection control solutions will continue to grow as payor reimbursement becomes more closely tied to how hospitals perform in the area of health care associated infections. Automated patient surveillance systems offer health care facilities the ability to identify pathogen patterns and identify when control limits have been reached. This may help health care professionals slow or even completely prevent outbreaks, representing a significant improvement over conventional methods of tracking infections.

FDA Recommends Radiation Exposure Measures For CT Manufacturers

Article preview from "The Gray Sheet" - November 15, 2010

FDA wants makers of computed tomography scanners to revamp user information materials and training programs and tweak some software/hardware components to reduce the chance of radiation overdoses to patients.

FDA Recommends CT Scanner Changes To Prevent Radiation Overdoses

Article preview from "The Gray Sheet" - November 10, 2010

FDA wants makers of computed tomography scanners to revamp user information materials and training programs and tweak some software/hardware components to reduce the chance of radiation overdoses to patients.