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Clearside Biomedical receives $4M venture capital investment

Technology developed by researchers at the Georgia Institute of Technology and Emory University for delivering drugs and other therapeutics to specific locations in the eye provides the foundation for a startup company that has received a $4 million venture capital investment.

6 Jan 2012

Olympus adds dissolvable sinus spacing and hemostat products to ENT portfolio

Olympus, a precision technology leader in designing and delivering innovative solutions in Medical and Surgical Products, among other core businesses, today announced the addition of a broad line of advanced, dissolvable sinus spacing and hemostat products to its already extensive ENT product portfolio. These products include spacers, foams and powders available in either plant-based or chitosan polysaccharide polymers.

From Evident Corporation - Life Sciences 6 Jan 2012

USP seeks feedback on recommendations for pharmaceutical supply chain integrity

As the pharmaceutical industry continues to globalize, the challenges of securing complex supply chains and protecting patients from counterfeit medicines, as well as the consequences of lapses in security or proper handling, have mounted.

5 Jan 2012

Congress returns to 'same old health fights' in 2012

Congress starts 2012 facing the same old health policy fights, including the GOP push to pay for a more permanent Medicare "doc fix" with cuts to health law programs or Medicare. Meanwhile, Politico Pro reports on how House Ways and Means Committee Chair Dave Camp, R-Mich., has been pivotal in Republican efforts to undermine the health overhaul law.

5 Jan 2012

Viewpoints: Sebelius on 'essential benefits'; WSJ columnist on Democrats' 'Mediscare' argument - is it a lie?

Insurance needs and health systems vary state to state, and experience tells us that the best way forward is not to mandate a one-size-fits-all answer. Instead, our approach gives states the flexibility to take their own paths, while ensuring they all end up in the best place possible: with an Affordable Insurance Exchange that offers access to comprehensive, quality, affordable health insurance to small business owners and individuals who currently have few good choices in an expensive and broken market.

5 Jan 2012

NovaSterilis awarded soft tissue processing patent

NovaSterilis Inc., specializing in developing applications for supercritical carbon dioxide, has been granted US Patent 8,034,288 B2. The patent, dated October 11, 2011 entitled “Method and Apparatus for Cleaning of Viable Donor Soft Tissue”, covers a new method for cleaning soft allograft tissue including tendon, fascia, and skin with a supercritical fluid, thus avoiding other harmful chemical solvents that may leave residual chemicals.

4 Jan 2012

St. Jude Medical meets stopping rule in RESPECT clinical trial, closes patient enrollment

St. Jude Medical, Inc., a global medical device company, today announced that it has met a stopping rule in its RESPECT clinical trial - triggered by reaching the protocol-required number of primary events in the trial, defined as stroke and all-cause mortality - and is closing patient enrollment.

4 Jan 2012

One-third of NIH-funded trials remain unpublished 51 months after completion

In a study that investigates the challenges of disseminating clinical research findings in peer-reviewed biomedical journals, Yale School of Medicine researchers have found that fewer than half of a sample of trials primarily or partially funded by the National Institutes of Health (NIH) were published within 30 months of completing the clinical trial.

4 Jan 2012

BioLineRx commences BCM CE Mark registration trial for prevention of cardiac remodeling following AMI

BioLineRx, a biopharmaceutical development company, announced today the commencement of the PRESERVATION I clinical trial, a CE Mark registration trial of BCM (BL-1040), a novel medical device intended for the prevention of cardiac remodeling following an acute myocardial infarction (AMI).

4 Jan 2012

Viewpoints: Giving states responsibility for 'essential benefits'; The cost of proton beam treatment; Health spending in 2012

The Obama administration surprised supporters and critics when it decided to let states define the "essential health benefits" that must be provided to their citizens under health care reform. ... Federal health officials will need to monitor developments during the transition period to make sure consumers and employers can easily compare the benefit packages offered by private insurers.

3 Jan 2012

AirStrip's mobile patient monitoring applications receive CE Mark

AirStrip Technologies, Inc. has received CE Mark certification to market its innovative mobile patient monitoring applications in the European Community as well as other international territories outside Europe, company officials announced today.

3 Jan 2012

Poly Implant Prothèse misleads TÜV Rheinland over silicone-filled breast implants

TÜV Rheinland has in February initiated proceedings against Poly Implant Prothèse with the French prosecution service in Marseille. PIP continued to mislead TÜV Rheinland as the experts were shown the conforming silicone and the correct documents during the inspections that were regularly performed at PIP production site. Therefore, the TÜV Rheinland auditors must have the impression that the production was operated correctly.

31 Dec 2011

FDA intiates measures to reduce risks from inadequate 'reprocessing' of reusable medical devices

Some medical devices are reused many times in surgical and exploratory procedures. They include instruments used in surgery (like clamps and forceps), and endoscopes (like bronchoscopes and colonoscopes) used to visualize areas inside the body.

29 Dec 2011

Delcath receives ISO 13485 Certification for Galway facility

Delcath Systems, Inc. today announced that the Company's Galway, Ireland location has achieved ISO 13485:2003 Certification—an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union.

28 Dec 2011

Allergan seeks to reassure surgeons, patients about safety of breast implants

Allergan, Inc. seeks to reassure patients and surgeons around the world utilizing Allergan's breast implant devices that its products are not part of the recent investigation into breast implant devices manufactured by French manufacturer, Poly Implant Prosthese (PIP) by regulatory authorities in Europe.

26 Dec 2011

TriVascular treats first Canadian patients with Ovation Abdominal Stent Graft

TriVascular, Inc. of Santa Rosa, California, announced today the first Canadian patients treated with its Ovation Abdominal Stent Graft. The innovative, ultra low profile (14F OD) system is designed to expand the patient population suitable for endovascular aortic repair (EVAR) by addressing a wider range of diseased anatomy.

22 Dec 2011

FDA approves Infrascanner to detect life-threatening brain bleeding

Battlefield corpsmen and medical professionals across the country gained a valuable tool last week, as the Food and Drug Administration approved the first hand-held device to detect life-threatening bleeding in the brain.

22 Dec 2011

Reva Medical commences its first clincial trial

Reva Medical, a medical device company, has today commenced the very first clinical trial of its ReZolve™ bioresorbable coronary stent. A patient in Brazil was implanted with the device overnight, which flags an exciting chapter for Reva Medical.

21 Dec 2011

FDA, other organizations unveil program to monitor cataract surgery devices

The U.S. Food and Drug Administration and other government and professional organizations today unveiled a program to monitor medical devices used in cataract surgery in an effort to stem outbreaks of a rare, inflammatory condition associated with the procedure.

21 Dec 2011

Even as it faces attack, health law implementation — and challenges — continue

The Hill and Reuters report on the health law's numerous 2012 battle fronts - starting with the Supreme Court's review of the law and moving toward the November elections. Meanwhile, however, other news outlets report on continuing implementation of the measure, including the creation of a federal health exchange and defense of its prevention fund.

20 Dec 2011