Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue.
CVM’s action comes after the center recently reexamined the safety profile of the drug and conducted a preliminary risk characterization that indicated there could be potential risk to human health from ingesting pork, especially pork liver, derived from carbadox-treated pigs. read more
Boston Scientific- Voluntary Recall of Fetch™ 2 Aspiration Catheter
PRNewswire/ — Boston Scientific (NYSE: BSX) has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage. The U.S. Food and Drug Administration (FDA) classified the action as a Class 1 recall. This recall designation means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death. read more
New vision club concept from Bierley significantly improves accessibility to high quality vision aids.
Electronic magnifier specialists Bierley have announced the launch of their new vision club concept. The Bierley Vision Club makes it easier and more affordable for anyone to access superior quality vision aids without the expensive initial outlay which prohibits many from accessing the required technology. This club concept is a unique step forward for those with poor vision, helping them to regain independence in a unique new way. read more
Medtronic Responds to Star Tribune Article Regarding INFUSE Bone Graft
This weekend, an article was published in the Minneapolis Star Tribune that criticized Medtronic’s handling of data collected during a retrospective chart review (RCR) of INFUSE Bone Graft between 2006-2008. The article makes insinuations that are false, and fails to include important information regarding the RCR and Medtronic’s actions. read more
BrainCool AB announces FDA grants Expedited Access Programme (EAP) for the Cooral System
BrainCool announced today that, based on recent communication and presentation of the clinical development plan of BrainCool AB to the U.S. Food and Drug Administration (“FDA”), the Company has been granted and been selected as part of the FDA “The Expedited Access Pathway (EAP) and priority review for the product The Cooral System for prevention of the oral mucositis – a severe side effect of oncology treatment”. read more
Mylan Launches First and Only Available Intermediate Dosage Strengths of Generic Lopressor® Tablets 37.5 mg and 75 mg
HERTFORDSHIRE, England and PITTSBURGH, April 11, 2016 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Metoprolol Tartrate Tablets USP, 37.5 mg and 75 mg, which is the generic version of Novartis’ Lopressor® Tablets. These strengths are the first and only available intermediate dosage strengths between the existing Metoprolol Tartrate Tablets USP strengths of 25 mg, 50 mg and 100 mg. Mylan currently is the only manufacturer that offers Metoprolol Tartrate Tablets in five strengths. read more
Preliminary Data From Turtle Beach’s Latest Clinical Study Suggests HyperSound Clear Has Potential To Alleviate Tinnitus
SAN DIEGO, April 11, 2016 /PRNewswire/ — Tinnitus is a serious and widespread hearing health problem, and preliminary data from the latest clinical study by Turtle Beach Corporation (NASDAQ: HEAR), a leading audio technology company for over 40 years, suggests that the Company’s revolutionary HyperSound Clear™ 500P directed audio system may have the potential to help people living with this condition. Commonly known as “ringing in the ears,” Tinnitus is the perception of sound when no actual external noise is present, and there is currently no cure for most types of Tinnitus. Additionally, the American Tinnitus Association1 states, “Millions of Americans experience Tinnitus, often to a debilitating degree, making it one of the most common health conditions in the country. The U.S. Centers for Disease Control estimates that 15% of the general public – over 50 million Americans – experience some form of Tinnitus, with approximately 20 million struggling with chronic Tinnitus, and two million living with extreme and debilitating cases.” read more
Planmed Clarity 3D – new DBT system receives CE mark and wins Red Dot Design Award
The Planmed Clarity ™ 3D digital breast tomosynthesis system and the Planmed Clarity ™ 2D full field digital mammography system have received the CE mark and are now available for sale in the EU and other countries where the CE mark applies. The systems have also won the prestigious Red Dot Design Award.
Digital breast tomosynthesis produces a 3D volume of the breast and resolves the challenge of overlapping tissue structures. This results in enhanced diagnostics, especially for patients with denser breast tissue. Planmed’s patented new tomosynthesis method significantly improves image accuracy and allows even the smallest details to be captured with great precision.
“We are very excited about the CE clearance, as it permits us to launch a new and improved method to combat breast cancer. The Red Dot Design Award is a further testament to our dedication and hard work”, states Jan Moed , Managing Director of Planmed. read more