TEWKSBURY, Mass.–(BUSINESS WIRE)–Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today announced that its HearTwave II System was cleared for sale by the Mexican regulatory authorities. In August 2010, the Company executed an exclusive distribution agreement with Mayerick S.A. de S.V. to distribute the HearTwave II System, including the Company’s proprietary Microvolt T-Wave Alternans™ (MTWA) software and Micro-V Alternans Sensors.
Regulatory Roundup
The FDA approves CIRCA’s temperature system
CIRCA Scientific Announces That FDA Clears Its New Rapid, Large-Area, and Radiopaque Temperature Sensing Probe and System
PARK CITY, Utah–(BUSINESS WIRE)–CIRCA Scientific today announced that its CIRCA S-CATH™ and CIRCA Temperature Monitoring System™ have received 510(k) clearance in the U.S. by the Food and Drug Administration (FDA).
The CIRCA S-CATH and the CIRCA Temperature Monitoring System address the problems associated with slow, single sensor, and small surface area standard esophageal temperature probes and monitors.
Smartphone app registered as a Class I medical device
This morning at the FDA’s public Workshop on its Mobile Medical Applications Draft Guidance, which it published in July, FDA senior advisor Bakul Patel noted that Medco had registered its smartphone app Medco Pharmacy App as a Class 1 medical device. The app became commercially available in mid-May and marked a collaboration between the pharmaceutical company and Verizon Wireless, which is offering the app in its VCAST application store. The app is also available for iPhone, Blackberry, and Android users…
TissuGlu gets CE Mark approval
First-of-Its-Kind Product to Help Plastic Surgeons Address Wound Drainage Challenges in Large Flap Surgeries
PITTSBURGH, Sept. 14, 2011 /PRNewswire/ — Cohera Medical, Inc.®, a rapidly growing medical device company, announced today that it has received CE Mark approval for its lead product, TissuGlu® Surgical Adhesive. CE Mark approval allows TissuGlu to be sold in the European Union.
TissuGlu is an internal surgical adhesive for large flap surgeries, such as abdominoplasties, that helps reduce fluid accumulation and the need for postsurgical drains. Its unique chemical composition is resorbable, non-toxic, forms a strong bond between tissue layers and allows for natural healing, which ultimately may provide the patient with a quicker return to normal activity.
The FDA has questions about Hansen’s pre-market application
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Zimmer gets pediatric clearance for its scoliosis implant
Fixation Implant System Now Indicated for Treatment of Scoliosis in Younger Patients
WARSAW, Ind., Sept. 14, 2011 /PRNewswire/ — Zimmer Holdings, Inc. (NYSE: ZMH; SIX: ZMH) announced today that it has received an additional clearance for its proprietary Universal Clamp Spinal Fixation System. A first for the United States, the system is now indicated for treatment of idiopathic and neuromuscular scoliosis in patients eight years of age or older. The Universal Clamp Spinal Fixation System is used in conjunction with spinal fusion surgeries.
Zimmer gets pediatric clearance for its scoliosis implant
Fixation Implant System Now Indicated for Treatment of Scoliosis in Younger Patients
WARSAW, Ind., Sept. 14, 2011 /PRNewswire/ — Zimmer Holdings, Inc. (NYSE: ZMH; SIX: ZMH) announced today that it has received an additional clearance for its proprietary Universal Clamp Spinal Fixation System. A first for the United States, the system is now indicated for treatment of idiopathic and neuromuscular scoliosis in patients eight years of age or older. The Universal Clamp Spinal Fixation System is used in conjunction with spinal fusion surgeries.
Advanced Bionics hearing implant back on the market | Regulatory Roundup
After nearly a year, Sonova Holding AG (SIX:SOON) subsidary Advanced Bionics was allowed back in the U.S. market with its HiRes 90K cochlear implant.
In the past few months, Advanced Bionics received approval to resume distribution in Canada and countries accepting the CE Mark.
Advanced Bionics Announces FDA Approval for U.S. Market Re-Entry of the HiRes 90K Cochlear Implant
— Distribution of HiRes 90K Cochlear Implants in the United States Now Under Way —
VALENCIA, Calif., Sept. 13, 2011 /PRNewswire/ — Advanced Bionics (AB), the only U.S.-based manufacturer of cochlear implants and a subsidiary of Switzerland-based Sonova, announced today the approval of the FDA for immediate market re-entry of the HiRes 90K cochlear implant in the United States. In recent months, Advanced Bionics received approval from several other regulatory agencies, including Health Canada and the European Notified Body, TUV, to resume distribution of the HiRes 90K implant to Canada and countries accepting the CE Mark.
Ultrasound weight loss system, Liposonix, approved by the FDA
Medicis Announces FDA Clearance of LIPOSONIX(R) System
SCOTTSDALE, Ariz., Sept. 8, 2011 — Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the LIPOSONIX® system for non-invasive waist circumference reduction. The LIPOSONIX system uses advanced high-intensity focused ultrasound (HIFU) technology to permanently destroy targeted fat just beneath the skin in the treatment area.
Fluke Biomedical scores FDA clearance for its vital signs simulators
FDA Grants Fluke Biomedical 510(k) clearance for new ProSim™ Vital Signs Simulators
EVERETT, WASHINGTON – The United States Food and Drug Administration (FDA) announced today it has granted the new Fluke Biomedical ProSim Vital Signs Simulators 510(k) clearance. These innovative new patient simulators, conceived and designed in partnership with biomedical technicians and clinical engineers around the globe, offer advanced technology for patient monitor testing.