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Hospitals pay more for devices, according to government study

Some hospitals pay thousands of dollars more than others for big-ticket medical devices such as defibrillators and hip replacements, and a portion of the higher costs could be passed on to the federal Medicare program, a new government report says.

6 Feb 2012

Vita Needle celebrates dual certifications of Quality Management Systems

Vita Needle Company recently celebrated dual certifications of its Quality Management Systems to the latest general ISO 9001:2008 and medical device manufacturing standards ISO 13485:2003. In addition, the fifth generation family business celebrated its 80th anniversary as well as the 18th record sales year in the last twenty years.

4 Feb 2012

AHF calls for top to bottom shake-up of management at FDA

AIDS Healthcare Foundation (AHF) today called for a top to bottom shake-up of the management at the Food and Drug Administration as well as a Congressional investigation following the publication of a Washington Post news article (1/31/12) that reported, "…the Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients."

3 Feb 2012

Fallout continues over Obama administration birth-control coverage rule

President Barack Obama's decision on this issue may offer insights into his approach to policy making. Meanwhile, kudos and criticism come from different sides of the issue.

3 Feb 2012

Medical device industry, FDA reach agreement in principle on user fee program

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

2 Feb 2012

FDA clears TearScience's LipiFlow Thermal Pulsation System to treat dry eye

TearScience, Inc., a privately-held medical device company, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its next generation product of its LipiFlow Thermal Pulsation System, a medical device that treats evaporative dry eye by liquefying and evacuating obstructions in meibomian glands located in the eyelids.

1 Feb 2012

CartiHeal secures $5M in venture funding

CartiHeal (2009), Ltd, a privately held medical device company, focused on developing and bringing to market a proprietary, off-the-shelf, and cell-free cartilage regeneration technology, announced that it raised $5 million in venture funding from two US-Israeli venture capital firms, Accelmed and Access Medical Ventures. The financing will be used to prepare its first product launch early 2013 in Europe.

1 Feb 2012

FDA faces legal attack over alleged spying on whistleblowers

A latest lawsuit filed in federal court has accused the Food and Drug Administration (FDA) of electronically spying on whistleblowers who alerted the Obama administration and Congress of alleged misconduct in the agency, particularly relating to what they claim was the push to approve unsafe and ineffective medical devices.

31 Jan 2012

ConforMIS raises $89M in Series E round of funding

Surpassing all previous fundraising rounds, privately-held medical device company ConforMIS, Inc. announced today that it has raised $89 million in a Series E round of funding, with additional funds beyond this amount committed upon meeting certain milestones.

30 Jan 2012

Viewpoints: Health law's consumer safeguards; Shredding Medicare's safety net; Georgia's trauma crisis

Requiring the makers of drugs and medical devices to disclose most payments and gifts to physicians will protect patients and reduce medical costs. ... [the federal health law] requires the makers of drugs and medical devices to disclose most payments and gifts to physicians (1/27).

30 Jan 2012

Sorin opens ACCESS training center in Clamart

Sorin Group, a global medical company and a leader in the treatment of cardiovascular diseases, announced today the opening of its Advanced Center for Continuous Education on Scientific Solutions - ACCESS - training center in Clamart.

27 Jan 2012

In State of the Union speech, health law gets short shrift

President Barack Obama's State of the Union address was light on health policy references, but he did say he would not "go back to the days when health insurance companies had unchecked power to cancel your policy, deny your coverage or charge women more than men." News outlets also reported on Indiana Gov. Mitch Daniels Republican response and looked forward to what Obama is doing today to spin his speech.

25 Jan 2012

St. Jude Medical fourth quarter net sales increase 4% to $1.407B

St. Jude Medical, Inc. today reported sales and net earnings for the fourth quarter and year ended December 31, 2011.

25 Jan 2012

Panel releases draft priorities for comparative effectiveness research

The draft, which offered insight into the Patient-Centered Outcomes Research Institute's priorities and research agenda, did not single out any specific diseases or treatments. The Institute did seek public comment.

25 Jan 2012

Targeted repeal votes part of House GOP health agenda

Some specific provisions the Republican leadership plans to hold repeal votes on include the Medicare advisory panel and the CLASS Act. Meanwhile, the AMA is pointing to "war savings" as a possible way to pay for the fix to the Medicare physician payment formula.

25 Jan 2012

UH Case Medical Center initiates enrollment in Moxy Drug Coated Balloon trial for PAD

Physicians at University Hospitals (UH) Case Medical Center enrolled their first patient in LEVANT 2, a global, multicenter, randomized clinical trial evaluating the safety and efficacy of the Moxy™ Drug Coated Balloon for the treatment of peripheral arterial disease.

25 Jan 2012

Cohera receives FDA IDE approval to initiate U.S. clinical study for TissuGlu

Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration ("FDA") to begin a prospective, multicenter, randomized clinical trial for its lead product, TissuGlu Surgical Adhesive in the United States.

25 Jan 2012

Johnson & Johnson fourth quarter sales increase 3.9% to $16.3 billion

Johnson & Johnson today announced sales of $16.3 billion for the fourth quarter of 2011, an increase of 3.9% as compared to the fourth quarter of 2010. Operational sales increased 4.0% and the negative impact of currency was 0.1%.

24 Jan 2012

Power3, Amarantus sign license agreement for NuroPro Blood Test for Parkinson's

Amarantus BioSciences, Inc., a biotechnology company developing MANF, a first-in-class disease-modifying therapeutic protein being developed for the treatment of Parkinson's Disease, today announced an exclusive worldwide license agreement with Power3 Medical Products, Inc. for the NuroPro Blood Test as it relates to Parkinson's disease diagnosis.

24 Jan 2012

PLC Systems initiates enrollment in RenalGuard pivotal trial for CIN

PLC Systems Inc., a company focused on innovative medical device technologies, announced the successful enrollment of the first patient in the CIN-RG trial, the company's pivotal trial to study the efficacy of its RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy.

24 Jan 2012