Category: Cardiac Assist Devices
The FDA issues a warning letter to Thoratec Corp. over the late filing of a pair of medical device reports, but the company says regaining the agency's good graces won't impact its operations or finances.
Thoratec Corp. (NSDQ:THOR) said the FDA sent it a letter warning about a pair of late filings with the federal watchdog agency, adding that resolving the issue shouldn't affect its operations or finances.
The warning letter, which the heart pump maker said it received Jan. 4, flagged the late reports after inspections in August and September 2011 brought them to light, according to a regulatory filing.
Heartware to fund development of left ventricular assist devices (LVADs) with spin-off from the German Aerospace Centre
HeartWare International (NSDQ:HTWR) and Dualis MedTech GmbH are teaming up to develop a wireless left ventricular assist device, in a deal that could help the Framingham, Mass.-based cardiac device maker expand its product portfolio.
Company officials said engineering teams from Dualis and HeartWare have been working together since mid-2011 and have, "successfully demonstrated the feasibility of integrating Dualis' proprietary wireless energy transfer technology with the HeartWare HVAD and MVAD systems," according to a prepared release.
Thoratec Corp. is readying a percutaneous heart pump and has submitted a 510(k) plan to the FDA, according to CEO Gary Burbach.
Pleasanton, Calif.-based Thoratec is getting into the ring with Abiomed (NSDQ:ABMD), preparing its version of a percutaneous heart pump to compete with the Impella device that Abiomed already has on the market, CEO Gary Burbach said at the JP Morgan health care conference this morning.
On the Berlin Heart, Alina Siman, 4, has regained her energy which will make her a better transplant candidate when a new organ becomes available
By Lindsay Hoshaw
Abiomed hopes to add a new ventricular assist device to its Impella line of heart pumps next year and plans to enter the Japanese market in 2013; also, Abbott, BSX facing new stent rival?; Baxter closes $500M bond deal; and analysts' ups & downs.
Amid celebrating the first human use of its Symphony implantable heart pump for chronic heart failure patients, Abiomed (NSDQ:ABMD) unveiled a new ventricular assist device for its flagship Impella line of heart pumps.
Announced at the company's annual investors' day in New York, the new device is slated to hit the market some time next summer. Abiomed also has its sights set on entering the Japanese market in 2013.
Thoratec Corp. appoints Immucor CEO and former Medtronic chief William Hawkins to its board of directors.
Cardiac device maker Thoratec Corp. (NSDQ:THOR) appointed former Medtronic (NYSE:MDT) CEO William Hawkins to its board of directors.
The current Immucor Inc. (NSDQ:BLUD) CEO brings more than 30 years of med-tech experience with him to the Pleasanton, Calif.-based boardroom.
Zonare Medical Systems Inc.
, Food & Drug Administration (FDA)
, Immucor Inc.
, Smith & Nephew
, Thoratec Corp.
, GI Dynamics
Infrascan's mobile brain bleed detector may help first responders detect brain bleeds at an injury site.
MASSDEVICE ON CALL — Infrascan's handheld brain bleed detector may be hit the U.S. market as early next year as the company hopes to get the FDA's okay within the next few months.
The device uses near-infrared imaging to detect bleeds at an injury site within the "golden hour," the period following head trauma when pre-hospital analysis is critical.