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'Adaptive' clinical trials now being planned at U-M, other sites

A new approach to testing medical treatment options could ensure that more patients get the most beneficial treatment for them - but still yield valuable research results that stand up to scientific scrutiny.

2 Jul 2012

ETView receives European pre-market clearance for Viva-EB airway device product family

ETView today announced that the company has received European pre-market clearance for the Viva-EB product family following review of a Technical File submission by Medical Device Certification GmbH ("MDC").

2 Jul 2012

Teleflex PICC receives FDA 510(k) clearance for central venous pressure monitoring

Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, today announced its ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter (PICC) has received FDA 510(k) clearance for central venous pressure (CVP) monitoring indication.

2 Jul 2012

Most health care firms expect to benefit from health law

The court's decision to uphold the law is expected to help nearly every corner of the health care industry, The Associated Press reports. But other outlets also note that insurers are concerned about new rules.

30 Jun 2012

Fidelitas introduces dispensing and documentation system for methadone treatment in Canada

Fidelitas Medical IT-Solutions, LP announced today the launch of their product DDS, a dispensing and documentation system for methadone treatment. Their mission, according to the company's CEO, Andreas Kunz, is to increase the safety and efficiency of Methadone Maintenance Treatment programs in Canada. "Methadone is useful in the treatment of opiate dependence, but it requires very careful, accurate and transparent handling."

30 Jun 2012

Some health system changes will move forward, regardless of the Supreme Court ruling

News outlets report that a "quiet revolution" in how care is delivered is already taking place across the country that closely tracks many of the changes advanced by the health law.

29 Jun 2012

Brolex announces C SAFE medical device now in distribution channels globally

Brolex announced today that the C SAFE cesarean section safety device is now in distribution channels across the United States and Internationally. These channels are providing hospitals in 10 states and 7 countries access to the C SAFE medical device. Over 60 US hospitals have now received these first supplies of C SAFE for their Labor & Delivery Departments.

29 Jun 2012

Results from Access’ MuGard Phase 4 trial on oral mucositis

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company developing treatments in areas of oncology and oncology supportive care, announced that Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC, presented results from its ongoing MuGard Phase 4 clinical trial in oral mucositis (OM) at the Multinational Association of Supportive Care in Cancer (MASCC) Conference in New York City.

29 Jun 2012

FSS’ FlexStent Iliac system receives CE Mark

Flexible Stenting Solutions, Inc., a leading developer of next generation peripheral arterial, venous, neurovascular and biliary stents, announced today that it has extended its CE Mark authorized family of peripheral vascular stents to include the FlexStent Iliac Self Expanding Stent System.

29 Jun 2012

Full results from Derma Sciences’ DSC127 Phase 2 trial on diabetic foot ulcers

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced that full results from its successful Phase 2 clinical trial with the investigational drug DSC127 in patients with diabetic foot ulcers will be published on July 5th in the July 2012 issue of Wound Repair and Regeneration.

28 Jun 2012

Nevro receives two key U.S. patents for Senza High-Frequency Spinal Cord Stimulation System

Nevro Corp., a medical device company focused on improving pain relief among patients suffering from debilitating chronic pain, announced today the issuance of two key patents related to the company's Senza High-Frequency Spinal Cord Stimulation System.

28 Jun 2012

Health Canada approves AutoGenomics’ INFINITI PGx testing system

AutoGenomics, a leader in providing automated, molecular microarray testing solutions, announced today that they have received their first Health Canada Medical Device Class III approvals for their automated INFINITI Pharmacogenomic (PGx) testing system.

28 Jun 2012

Analyzing the FDA bill's course: Bipartisanship or something else?

The bipartisan treatment the FDA user fee bill has enjoyed did not fall like manna from heaven. It came at the insistence of the pharmaceutical and medical device industries, the FDA and legislators on both sides of the aisle who agreed early on they would get a deal done. And then actually did it.

27 Jun 2012

Two major organizations partner in new vendor-neutral health IT innovation network

Two major non-commercial health information technology organizations are working together in a new vendor-neutral health IT innovation network designed to stimulate development of new ideas and shorten the time required to bring new solutions into practice.

27 Jun 2012

Positive results from Antares Pharma's VIBEX MTX human factors usability study for RA

Antares Pharma, Inc. today announced positive results from a human factors usability study for VIBEX Methotrexate (MTX), a proprietary auto injector product designed to self-administer a rapid subcutaneous weekly injection of methotrexate for the treatment of rheumatoid arthritis (RA).

26 Jun 2012

Covidien acquires Oridion Systems

Covidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today said that it has completed the previously announced acquisition of Oridion Systems Ltd. for an aggregate consideration of approximately $310 million, net of cash and investments acquired.

26 Jun 2012

First Edition: June 26, 2012

Today's headlines include reports setting the scene for Thursday's Supreme Court decision that will determine the health law's future.

26 Jun 2012

Clinical study to examine retrograde tibiopedal interventional approach for CLI

Clinical investigators are for the first time examining the retrograde tibiopedal interventional approach, an endovascular technique that has the potential to reduce the rate of leg amputations by as much as 50 percent in patients with critical limb ischemia (CLI), a manifestation of peripheral arterial disease (PAD).

26 Jun 2012

Flavocoxid liver damage reported

A prescription medical food used to treat osteoarthritis may induce reversible liver damage in some users, suggests research published in the Annals of Internal Medicine.

25 Jun 2012

Vasomedical subsidiary amends sales representative agreement with GE Healthcare

Vasomedical, Inc. a diversified medical technology company specializing in the design, manufacture and sale of medical devices and in the domestic sale of diagnostic imaging products, today announces the amendment of the sales representative agreement between its subsidiary, Vaso Diagnostics Inc. d/b/a Vaso Healthcare and GE Healthcare, the healthcare business unit of GE, originally signed on May 19, 2010.

25 Jun 2012