Medical Devices News and Research

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As state legislatures gear up, federal health overhaul is on their agenda

The New York Times Prescriptions Blog: "The question of equality, or inequality, among states is a major reason President Obama's overhaul of the health care system, and the legislation in Congress to make it happen, seemed to reach the brink of collapse last week." The issue also reflects "one of the biggest challenges" the President and Congressional leaders face in their efforts to overhaul the health care system. The key question: "how to devise a national solution for a problem that varies sharply from state to state."

27 Jan 2010

Proposal for NHI to be the most significant development in South Africa's healthcare sector in 2010

The proposal for a National Health Insurance (NHI) was without doubt the most significant development in South Africa's healthcare sector in 2010. The aim of the NHI is to create universal healthcare coverage for all the country's citizens.

25 Jan 2010

Challenges related to premarket clearance process for medical devices: FDA schedules public meeting

The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.

23 Jan 2010

Stem Cell Assurance, MDwerks announce financing and marketing partnership

Stem Cell Assurance, Inc. and MDwerks, Inc. announced today a financing and marketing partnership today wherein MDwerks, through it's Xeni Finance subsidiary, has provided the first tranche of financing to Stem Cell for the purchase of various medical devices from Cytori Therapeutics, Inc.

21 Jan 2010

Health care companies assess where they stand on health reform after election

The Wall Street Journal reports that several firms reiterated support for a health care reform bill Wednesday, a day after the overhaul's viability was called into question by the victory of Republican Sen.-elect Scott Brown in Massachusetts. "PhRMA, the drug industry association, as well as companies including Pfizer Inc., Johnson & Johnson, WellPoint Inc. and Humana Inc., voiced support for an overhaul of some kind, despite objections among insurers about the efforts to date."

21 Jan 2010

Enrollment complete in Vertos Medical's U.S. IRB I "mild" procedure Patient Outcomes Trial

Medical device company Vertos Medical Inc. has announced the completion of enrollment in its post-market U.S. IRB (Institutional Review Board) I Patient Outcomes Trial, a 75-patient study of the mild procedure. The open-label, single-arm, prospective, IRB-approved study is intended to gather patient outcomes data following treatment for symptomatic central canal spinal stenosis using proprietary mild devices. Results from the trial, which is being conducted by 14 investigators at academic and private practice settings across the United States, are expected to be published during 2010.

21 Jan 2010

BioLife Solutions announces biologic packaging products pre-filled with GMP biopreservation media

BioLife Solutions, Inc., a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, and OriGen Biomedical, a leading provider of biologic packaging products for research and clinical blood and cell-based therapies, today announced that the companies will introduce sterile standard and custom biologic packaging products pre-filled with BioLife's serum-free, protein-free HypoThermosol® cell and tissue storage/transport media and CryoStor™ cryopreservation media.

21 Jan 2010

Medical Care Technologies to include HVS as add-on to its Tele-Health Suite

Medical Care Technologies Inc. today announced that it has been developing its latest medical device technology -- Heart Vital Signs ("HVS") to be included as an add-on to its Tele-Health™ Suite. Remote cardiac monitoring technologies allow home electrocardiographic (ECG) monitoring of patients with suspected cardiac arrhythmias or at risk for developing arrhythmias.

21 Jan 2010

Given Imaging includes Aptina’s image sensor in its PillCam capsule

Aptina announced today that Given Imaging Ltd.’s PillCam® COLON 2 includes Aptina’s MT9S526 medical image sensor. All three of Given Imaging’s patient-friendly, ingestible PillCam® products for small bowel, esophageal, and now colon imaging include Aptina’s sensors embedded within the Given Imaging capsules.

21 Jan 2010

Healthcare industry in Asia Pacific to grow up to US$349 billion by 2012

Frost & Sullivan believes that the healthcare industry is undergoing a paradigm shift from "sickness care" to "wellness". Focused on the 5 Ps – Preventive, Pre-emptive, Personalized, Predictive and Personal Responsibility – the healthcare industry in Asia Pacific is expected to grow to US$349 billion by 2012.

21 Jan 2010

Australia issues patent covering Kane Biotech's DispersinB anti-biofilm technology

Kane Biotech Inc., a biotechnology company engaged in the development of products that prevent and disperse microbial biofilms, is pleased to announce the issuance of Patent No. 2003284385 entitled "Compositions and methods for enzymatic detachment of bacterial and fungal biofilms" by IP Australia (Australian Patent and Trademark Office).

21 Jan 2010

Smith & Nephew makes available more than $2M in implants and surgical instruments for Haiti earthquake victims

Medical device maker Smith & Nephew's Orthopaedics business is making available this week more than $2 million in implants and surgical instruments for use by orthopedic surgeons in the treatment of survivors of last week's earthquake in Haiti.

21 Jan 2010

U.S. District Court finds Johnson & Johnson patents as invalid

Boston Scientific Corporation (NYSE: BSX) announced today that the U.S. District Court for the District of Delaware has found all four patents in a suit involving Johnson & Johnson to be invalid.

21 Jan 2010

Gambro acquires CHF Solutions

Gambro and CHF Solutions, Inc. (CHF) announced today that Gambro has acquired CHF, a medical device company that manufactures and distributes ultrafiltration devices to treat fluid overload.

20 Jan 2010

Covidien announces results for first-quarter of fiscal 2010

Covidien plc today reported results for the first quarter of fiscal 2010 (October – December 2009). First-quarter net sales of $2.7 billion were up 7% from the $2.6 billion reported a year ago, with favorable foreign exchange of $121 million increasing the quarterly sales growth rate by approximately 5 percentage points.

20 Jan 2010

Hospital for Special Surgery helps Haiti victims

A team of anesthesiologists, nurses and orthopedic trauma surgeons from Hospital for Special Surgery in Manhattan headed for Haiti on Friday and have been performing surgery and tending to those impacted by the earthquake ever since.

20 Jan 2010

Simbionix introduces new module for ANGIO Mentor simulator

Simbionix, the world's leading developer of medical simulation systems, introduces its new module for the ANGIO Mentor simulator, the Percutaneous Aortic Valve Replacement Module, which provides physicians with an opportunity to practice a revolutionary endovascular implantation of a bioprosthesis, without performing cardiac surgery.

20 Jan 2010

St. Jude Medical completes second interoperability testing process for Merlin.net Patient Care Network

St. Jude Medical, Inc. today announced it has successfully completed its second interoperability testing process for the company’s Merlin.net™ Patient Care Network, an Internet-based repository of patient and implantable device data.

20 Jan 2010

GEH, Exelon Generation agree to a landmark deal to deploy GEH’s isotope generation technology

Seeking to address a growing demand for the domestic and global supply of cobalt-60, a radioisotope used for treating cancer and other biomedical applications, GE Hitachi Nuclear Energy (GEH) and Exelon Generation Company have agreed to a landmark deal to deploy GEH’s isotope generation technology.

20 Jan 2010

Medpro Safety Products purchases product development rights from Visual Connections

MedPro Safety Products, Inc., a leading developer of transformational technologies that enable safer medication delivery and blood collection systems, has purchased product development rights for a unique, fully passive Insulin Guard self-injector from Visual Connections, owned by Hooman Asbaghi. Mr. Asbaghi is the inventor of MedPro’s fully passive phlebotomy collection devices, which include two versions of a safety blood collection holder, a passive IV catheter, and a safety blood collection set.

19 Jan 2010

Medical Devices News and Research

As state legislatures gear up, federal health overhaul is on their agenda

Proposal for NHI to be the most significant development in South Africa's healthcare sector in 2010

Challenges related to premarket clearance process for medical devices: FDA schedules public meeting

Stem Cell Assurance, MDwerks announce financing and marketing partnership

Health care companies assess where they stand on health reform after election

Enrollment complete in Vertos Medical's U.S. IRB I "mild" procedure Patient Outcomes Trial

BioLife Solutions announces biologic packaging products pre-filled with GMP biopreservation media

Medical Care Technologies to include HVS as add-on to its Tele-Health Suite

Given Imaging includes Aptina’s image sensor in its PillCam capsule

Healthcare industry in Asia Pacific to grow up to US$349 billion by 2012

Australia issues patent covering Kane Biotech's DispersinB anti-biofilm technology

Smith & Nephew makes available more than $2M in implants and surgical instruments for Haiti earthquake victims

U.S. District Court finds Johnson & Johnson patents as invalid

Gambro acquires CHF Solutions

Covidien announces results for first-quarter of fiscal 2010

Hospital for Special Surgery helps Haiti victims

Simbionix introduces new module for ANGIO Mentor simulator

St. Jude Medical completes second interoperability testing process for Merlin.net Patient Care Network

GEH, Exelon Generation agree to a landmark deal to deploy GEH’s isotope generation technology

Medpro Safety Products purchases product development rights from Visual Connections

Industry Focus - Medical Device eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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