Medical Devices News and Research

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Teleflex announces acquisition of Semprus BioSciences

Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, announced it has acquired Semprus BioSciences, a biomedical company and spin out from Massachusetts Institute of Technology.

25 Jun 2012

ETView’s VivaSight-DL product family receives pre-market clearance

ETView today announced that the company has received pre-market clearance for the VivaSight-DL product family following review of a Technical File submission by Medical Device Certification.

25 Jun 2012

FDA advisory panel issues positive opinion for Dune's MarginProbe System

Dune Medical Devices announced today that a U.S. Food and Drug Administration (FDA) Advisory Panel voted (10 to 1) in favor of Dune's MarginProbe System for use in breast cancer surgery, as an adjunct to current standard methods of intraoperative surgical margin assessment.

23 Jun 2012

Alexza resubmits ADASUVE NDA to U.S. FDA

Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2012.

22 Jun 2012

Ambulatory monitoring will become more and more part of patients' everyday lives

In the future, patients will become even more involved in the observation and monitoring of their own health or illnesses. For example, blood pressure can be checked 24 hours a day using a blood pressure cuff at home.

22 Jun 2012

Selenium reduces Staph populations in medical implants

Selenium is an inexpensive element that naturally belongs in the body. It is also known to combat bacteria. Still, it had not been tried as an antibiotic coating on a medical device material. In a new study, Brown University engineers report that when they used selenium nanoparticles to coat polycarbonate, the material of catheters and endotracheal tubes, the results were significant reductions in cultured populations of Staphylococcus aureus bacteria, sometimes by as much as 90 percent.

22 Jun 2012

Biomimedica closes Series-B financing

Biomimedica, Incorporated, a medical device start-up company focused on the development and commercialization of its proprietary GRADION Total Cartilage Replacement technology, announced today that it has closed its Series-B financing, raising $11.9 million from a combination of new and existing investors, including conversion of approximately $2.8 million in bridge loans.

22 Jun 2012

FDA clears expanded indications for InTouch Health Remote Presence devices

InTouch Health, the world's premier provider of acute care telemedicine solutions, has received a new Food and Drug Administration (FDA) 510(k) clearance with expanded indications for use for its range of Remote Presence devices which includes RP-7i®, RP-Lite®, RP-Vantage® and RP-Xpress® as well as VisitOR1® which is sold by and is a registered trademark of Karl Storz.

19 Jun 2012

ASI completes $5.3 million Series A Preferred Stock financing

Ablative Solutions, Inc. (ASI), a privately-held company headquartered in Kalamazoo, MI with offices in Menlo Park, CA announced today that it has completed a Series A Preferred Stock financing, totaling approximately $5.3 million (including the conversion of the bridge financing completed earlier this year), to fund its unique technology platform.

19 Jun 2012

T2Endotoxin assay extends reach of T2MR detection

T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced the presentation of data on endotoxin detection at the American Society for Microbiology General Meeting, June 16-19, 2012, in San Francisco, CA.

18 Jun 2012

FDA clears St. Jude Medical's AMPLATZER Vascular Plug 4 for transcatheter embolization

St. Jude Medical, Inc., a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance and will immediately launch the AMPLATZER Vascular Plug 4 (AVP 4) for use in transcatheter embolization procedures (minimally invasive procedures that involve the selective blocking of blood vessels) within the peripheral vasculature.

18 Jun 2012

Health Canada approves Viveve System to improve sexual function after childbirth

Viveve, Inc., a woman's health company and pioneer in non-surgical vaginal tissue restoration, announces Health Canada has issued a Medical Device License for the Viveve System to treat laxity of the vaginal introitus (opening) after vaginal childbirth, to improve sexual function. The Viveve procedure is the first of its kind and clinical results have shown an improvement in the feeling of vaginal tightness and sexual satisfaction for women.

18 Jun 2012

Dehaier, Heyer enter into three-year strategic mutual cooperation agreement

Dehaier Medical Systems Ltd., an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, today announced that the Company has entered into a three-year strategic mutual cooperation agreement with HEYER Medical AG, an internationally recognized, Germany-based company specializing in state-of-the-art inhalation and anesthesia equipment, oxygen concentrators, breathing therapy equipment and connecting equipment.

18 Jun 2012

GAO: Medicaid anti-fraud audit program falls short on cost-benefit analysis

Private contractors received $102 million to review Medicaid fraud data, yet had only found about $20 million in overpayments since 2008, according to a new report by the federal government.

16 Jun 2012

Six-month data from ReCor’s PARADISE System trial on resistant hypertension

ReCor Medical, an emerging medical device company, reported today six-month follow-up data on eight patients who have been treated via renal denervation for their resistant hypertension with the Company's PARADISE System—the only system for renal denervation that is based on ultrasound, not radiofrequency, energy.

16 Jun 2012

CardioFocus, CryoLife resolve outstanding patent dispute

CryoLife, Inc., a leading medical device company focused on cardiac and vascular surgery, announced today that it has entered into a settlement agreement with CardioFocus, Inc. ending the outstanding patent dispute between CryoLife's wholly owned subsidiary, Cardiogenesis Corporation, and CardioFocus that was pending in the United States District Court of Massachusetts.

15 Jun 2012

Positive results from Salutaris’ episcleral brachytherapy trial on Wet AMD

Positive results from a trial of episcleral brachytherapy to treat Wet Age-related Macular Degeneration (Wet AMD) were presented today at the ARVO Drug and Gene Delivery to the Back of the Eye Conference.

15 Jun 2012

Impel NeuroPharma announces important POD technology milestones

Impel NeuroPharma, a medical device company developing a novel drug delivery device that enables drugs to bypass the blood-brain barrier (BBB) using direct nose-to-brain delivery, today announced a set of important milestones in its drive to commercialize its POD technology.

15 Jun 2012

Gore launches CQI study for DUALMESH Biomaterial to treat ventral hernia

W. L. Gore & Associates (Gore) continues its commitment to improving patient outcomes in hernia patients, with the launch of a clinical quality improvement (CQI) study for GORE DUALMESH Biomaterial in laparoscopic repair for ventral hernia patients.

15 Jun 2012

CryoLife reaches full settlement in Medafor lawsuit

CryoLife, Inc., a leading medical device company focused on cardiac and vascular surgery, announced today that it has reached full settlement of the outstanding CryoLife, Inc. v. Medafor, Inc. lawsuit that was pending in the Northern District Court of Georgia.

15 Jun 2012