Medical Devices Drugs & Biologics Food & Dietary Supplements Tobacco Medical Devices
Covidien gets FDA nod for embolic protection device The FDA has granted Covidien 510(k) clearance for its SpiderFX device, which is used in combination with plaque excision to treat severely calcified lesions in arteries found in the lower extremities. The device is the only embolic protection device cleared in the U.S. for lower extremity use, the company said in a release.
Alere acquires Arriva Medical for $65 million, plus stock Arriva Medical, which supplies blood glucose monitors and other diabetes testing devices to patients' homes, has been acquired by in vitro diagnostics firm Alere for $65 million in cash, plus 806,452 restricted company shares. The deal will allow Alere to expand its footprint in the point-of-care diabetes diagnostics arena.
Quanterix wins federal contract to develop toxin assay The Department of Homeland Security has awarded Quanterix a $250,155 contract to create an assay that would be a thousand times more sensitive than existing tests in detecting botulinum toxin. The company, which will work with the University of Massachusetts' Botulinum Research Center, will develop the test using its Single Molecule Array tool.
Toshiba introduces ultrasound systems at RSNA meeting Toshiba unveiled at the Radiological Society of North America meeting in Chicago its Aplio 300 and 500 ultrasound devices, which the company says have already won FDA clearance. The Aplio 300 is designed for use in routine cardiac, radiology and OB/GYN sonograms, while the Aplio 500 is an advanced version that features the company's Smart Fusion and Fly Thru systems.
FDA guidance maps regulatory pathway for artificial pancreas The FDA has unveiled draft guidance outlining the process for developing and seeking regulatory approval for artificial pancreas systems, a potential cutting-edge treatment for type 1 diabetes. The guidance aims to provide a clear pathway for the devices from clinical trials to outpatient studies to help bring the products to market faster.
Toronto firm strikes $3M marketing deal with Kinetic Concepts Kinetic Concepts has agreed to commercialize Novadaq Technologies' Spy fluorescence imaging device, which enables real-time assessment of tissue perfusion, in Europe, North America and Japan over six to seven years. The Toronto-based company will receive from KCI $3 million in upfront cash, plus milestone payments.
Applied Medical's feeding tube lands 510(k) clearance The FDA has given Applied Medical Technology the go-ahead to market its Low-Profile Transgastric-Jejunal Feeding Tube Kit, which is used to administer liquid nutrients to the middle part of the small intestine.
3 heart devices from Boston Scientific win FDA approval Boston Scientific has received FDA approval for its three defibrillators, called Incepta, Punctua and Energen, which are used to treat sudden cardiac death and heart failure. The devices feature the company's DF4 universal connector tool to work with thinner and smaller platforms, and its Latitude Heart Failure Management tool to allow for remote surveillance.
Juventas agrees to all-stock buyout by Wound Management Wound Management Technologies has offered to buy Juventas, a national distributor of devices used for regenerative medicine and surgical and nonsurgical therapy, through an all-stock transaction. The deal would allow owners of Juventas initially to gain 12.5 million shares of Wound Management Technologies, plus the possibility of gaining more shares in the future based on revenue performance.
Funding round brings in $30 million for CircuLite CircuLite has raised $30 million in a series D funding round led by Forbion Capital Partners and McAndrews & Forbes Holdings. The Saddle Brook, N.J.-based firm will use the proceeds to help launch in the European market its Synergy device, which is touted as the world's smallest heart pump, as well as support a pilot trial of the product in the U.S.
International Medical Device Regulators Forum unveils website The International Medical Device Regulators Forum has made its presence officially known with the creation of a website that offers information about its composition, origins and structure. The forum, which is being set up to succeed the Global Harmonization Task Force, is a regulators-only entity, whereas the task force had included industry members.
Taris begins midstage trial of bladder drug-delivery tool Taris Biomedical initiated a Phase II study of LiRIS, a device that delivers FDA-approved lidocaine to treat interstitial cystitis. Taris also is pursuing a drug candidate for other bladder disorders.
FDA clears mobile imaging app from GE Healthcare The FDA has granted GE Healthcare 510(k) clearance for its Centricity Radiology Mobile Access 2.0 imaging application. The technology, which works with Apple iOS and Android devices, is designed to give users remote access to MRI and CT exams.
Korea approves Cynosure's cellulite laser workstation Cynosure has secured approval in Korea to market its Cellulaze laser workstation, which is billed as the first aesthetic device that allows long-term cellulite reduction with minimal invasion.
Men are less willing to get cancer screening, researchers say A study in the American Journal of Men's Health showed that males aged 30 to 59 were less inclined to participate in cancer screening than their female counterparts. However, data also revealed that men were slightly more willing to get screened for cancer than women if provided with more information on the procedures. Study author Jenna Davis said the findings underscore the "need for better health and cancer screening promotion among men."
Segterra unveils InsideTracker online blood test tool Segterra has launched an online health tool called InsideTracker. The system uses blood tests to measure the vitamins and nutrients in the blood and to recommend measures for improving health and athletic performance.
Japanese regulators clear Visian Toric lens from STAAR Surgical The Japanese Ministry of Health, Labor and Welfare has given STAAR Surgical the go-ahead to market its implantable collamer lens, called the Visian Toric device, in...