Archive for ◊ October, 2013 ◊

• Thursday, October 31st, 2013

King Systems – owned by Ambu A/S – has received a Warning Letter from the U. S. Food and Drug Administration (FDA) relating to an inspection of the King Systems manufacturing site in Noblesville, USA. The Warning Letter references King Systems’ reply to the inspectional observations left by the FDA at the conclusion of the […]

• Thursday, October 31st, 2013

Medtronic Inc’s CoreValve heart valve implant significantly lowered death and stroke rates in frail, elderly patients with severe aortic stenosis who were considered too ill for surgery, according to data from a late-stage clinical trial. Medtronic is preparing to launch the product in the United States, pending regulatory approval. It will compete with Edwards Lifesciences’ […]

• Tuesday, October 29th, 2013

ABBOTT PARK, Ill., Oct. 25, 2013 /PRNewswire/ — Abbott today announced that its first-in-class, catheter-based MitraClip therapy has received U.S. Food and Drug Administration (FDA) approval and will launch immediately in the United States, providing physicians with a breakthrough treatment option for patients suffering from mitral regurgitation (MR). The MitraClip device has been approved for patients with significant symptomatic degenerative […]

• Monday, October 28th, 2013

Vascular Solutions (NSDQ:VASC) said it agreed to settle a patent infringement beef with Terumo Corp. (TYO:4543) over hemostasis devices for a 1-time payment of $812,000 and a promise from Terumo not to sue again over Vascular Solutions’ Vasc Band device. Terumo sued Vascular Solutions in February, accusing it and Chinese contract manufacturer Lepu Medical Technology infringing the patents […]

• Monday, October 28th, 2013

A day after disclosing it will shed 1,500 jobs worldwide, Boston Scientific Corp.’s leader said Thursday that the Natick medical device maker will probably add employees in its home state. Most of the cuts in the two-year restructuring — Boston’s Scientific’s third streamlining since 2011 — will be made at manufacturing plants around the globe, […]

• Friday, October 25th, 2013

Zynex, Inc. (OTCQB: ZYXI), a provider and developer of non-invasive medical devices for electrotherapy and stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced today that China’s State Food and Drug Administration (SFDA) has granted clearance to market its NeuroMove stroke recovery device.The NeuroMove device increases the functionality of many stroke victims by teaching the healthy parts […]

• Friday, October 25th, 2013

Amid a flurry of layoffs and restructuring after failed attempts to win FDA approval, New York device maker Delcath Systems aims for a $7.5 million funding round. New York’s Delcath Systems (NSDQ:DCTH) is looking to raise about $7.5 million through sales of common stock, planning on using the funds for working capital, commercialization efforts, clinical trials and other […]

• Friday, October 25th, 2013

Boston Scientific Corp. (BSX), the second-biggest maker of heart-rhythm aids, plans to eliminate as many as 1,500 more positions as the medical-device industry struggles with shrinking markets and development costs. The job cuts, slated to take place through 2015, should reduce operating expenses before taxes by $150 million to $200 million, Natick, Massachusetts-based Boston Scientific […]

• Thursday, October 24th, 2013

US surgical device maker Stryker has submitted plans for a $30m (€22m) expansion to its Cork facility that will make the location a hub for the group’s R&D activity. Stryker, which also makes orthopaedic implants, announced last year that it planned to make the major investment in its existing Cork facility. The plans have just […]

• Thursday, October 24th, 2013

Medtronic warns that a single lot of its NC Sprinter balloon dilation catheters are labeled with the incorrect size. Canadian healthcare regulators issued notice that Medtronic (NYSE:MDT) has asked for the return of all NC Sprinter Rx balloon dilation catheters from a single lot after discovering that the devices are mislabeled. A compliance chart packaged with the lot […]