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Regulatory roundup: Abbott wins FDA 510(k) and Japanese approval for Trek coronary balloon

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Clearances roundup
  • Abbott wins FDA 510(k) and Japanese approval for Trek coronary balloon
    Abbott Laboratories (NYSE:ABT) received 510(k) clearance from the Food & Drug Administration and approval from Japanese regulators for its TREK and MINI-TREK Coronary Dilatation Catheters for the treatment of coronary artery disease. The TREK system is used in angioplasty procedures and is designed to enable interventional cardiologists to open patients’ narrowed coronary arteries. The TREK system received CE Mark approval and was launched in Europe in May 2010.
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  • Boston Scientific lands FDA approval of Renegade HI-FLO Fathom pre-loaded system
    Boston Scientific Corp. (NYSE:BSX) announced that the FDA approved its Renegade HI-FLO pre-loaded system for selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature. The system will primarily be used by interventional radiologists for minimally invasive procedures to treat uterine fibroids and liver cancer. The Company said it plans to launch the product immediately in the United States.
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  • Guided Therapeutics wins ISO certification
    Guided Therapeutics Inc. (OTC:GTHP), developer of the LightTouch, a rapid, non-invasive and painless test for the early detection of cervical pre-cancer currently under review at the FDA, announced that it was awarded ISO 13485:2003 registration certification. The certificate of registration was issued by Intertek Testing Services NA Ltd. Intertek is a leading provider of quality and safety solutions, serving a wide range of industries around the world.
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  • Expression Analysis receives CLIA certification
    Expression Analysis, a leading provider of genomic services for clinical trials and research, announced it has received Clinical Laboratory Improvement Act certification. This milestone comes as the company enters its tenth year of providing genomic expertise; something the company refers to as “Genomic Know-How.” The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing — except research — performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments. CLIA is a regulatory program that sets quality standards for operating a clinical laboratory to ensure the accuracy, reliability and timeliness of patient test results.
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  • Sorin Group lands CE Mark approval for self-anchoring aortic heart valve, Perceval S
    Sorin Group, (MIL:SRN), a global medical device company and a leader in the treatment of cardiovascular diseases, announces the commercial availability in Europe of the self-anchoring PercevalTM S aortic heart valve. The innovative next-generation valve represents the latest innovation in heart valve technology. The Perceval S Sutureless biological valve is indicated for the rapid and minimally invasive surgical replacement of the aortic valve in patients suffering from aortic stenosis. Aortic stenosis is the most common acquired valvular heart disease in the western world, according to the company.
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  • SoundBite hearing system receives FDA 510(k) clearance for treatment of single sided deafness
    Sonitus Medical Inc., a medical device company that manufactures the world’s first non-surgical and removable hearing prosthetic to transmit sound via the teeth, announced that it has received FDA clearance for its SoundBite Hearing System. The FDA 510(k) clearance is the first for the company and the product.
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  • Osyris Medical wins FDA 510(K) for its LipoControl laser assisted lipolysis system
    Osyris Medical, a medical laser company, announced that it has received clearance from the FDA for its LipoControl system for laser assisted lipolysis. The LipoControl is the latest generation of 980nm diode designed to be a workhorse in the operating room for laser assisted lipolysis. The LipoControl offers “real time” Energy Mapping technology with motion sensing and Energy Memory features included. This patented technology is only available thru Osyris Medical and offers the physician the highest level of control and safety available in today’s market.
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  • Microsulis Medical receives Health Canada approval of the Accu2i percutaneous microwave tissue ablation device
    Microsulis Medical Ltd, a company in microwave technology for medical devices, announced that it has received approval from Health Canada for the Acculis Accu2i percutaneous microwave tissue ablation (pMTA) system for the coagulation of soft tissue during surgical procedures. The system has already been in use in Europe and the United States treating liver and lung tumors via a small 1.8 mm needle puncture of the skin. This groundbreaking treatment allows physicians to apply precise microwave energy to remove unwanted tissue masses whilst avoiding the risks associated with longer, more invasive surgical interventions.
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