Global medical device consulting firm Emergo Group Inc. surveyed more than 1,000 medical device manufacturers, distributors and industry service providers about the current state of their company and prospects for 2009.
Despite a continuing trend of gloomy economic data that seems to show the world economy slipping into recession, most medical device companies report positive domestic and international sales growth and continued optimism about prospects Read the rest of this entry »

Citing a recent U.S. Supreme Court decision, a federal judge in St. Paul on Monday dismissed dozens of lawsuits filed by patients who claimed they were injured by a heart device made by Medtronic Inc.
The patients were implanted with an electrical lead used in a defibrillator system known as Sprint Fidelis made by the Fridley-based medical technology company.
In October 2007, Medtronic’s popular Sprint Fidelis lead was recalled by the Food and Read the rest of this entry »

NanoVibronix, a medical device company, announced that the US Food and Drug Administration (FDA) has granted 510K clearance to market PainShield MD, an ultrasonic device used to treat pain.
PainShield is the first hands-free, patch-based device, thus allowing for an entirely new dimension in ultrasound treatment of pain and soft tissue healing. The PainShield consists of a disposable patch connected to a portable reusable driver and propagates Read the rest of this entry »

-(Dow Jones)- Some of the most risky medical devices weren’t
carefully reviewed by the Food and Drug Administration before they went on the
market, a U.S. government watchdog report said Thursday.
The report, by the Government Accountability Office, said the FDA needs to
take immediate steps to ensure that high-risk medical devices, such as external
cardiac compressors, get approved through the agency’s lengthy review process,
not just cleared.
Read the rest of this entry »

The site an International Harvester plant in Fulton County once sat on will finally occupy a manufacturer, 25-years after that company left the community.
Officials in Canton Thursday announced that Bloomington, Indiana-based Cook Medical will build a 45,000 square foot, $5.5 million plant on part of the old IH site.
The announcement was made at a church across from the site,where local residents and state officials stood and cheered when the Read the rest of this entry »

A medical device company hits some snags as it seeks FDA approval of an imaging device for breast cancer. A congressman puts in a call to the FDA. Bam! Product approved.
That’s the drift of internal documents that some FDA scientists are bringing to light in their complaints over what they say is too much lenience in the FDA’s approvals of medical devices, according to a
in this morning’s New York Times.
The congressman was Read the rest of this entry »

Texas’ ArthroCare medical device company CEO and two other executives resign.
West Palm Beach, FL (JusticeNewsFlash.com)–ArthroCare Corp., a medical device company, specializing in products for doctors and surgeons, received the resignations of Mike Baker, CEO and two other top company executives on Thursday. The Austin American-Statesman reported the medical device company, who is famous for manufacturing a wand used in percutaneous microdiscectomy Read the rest of this entry »

On the same day last month that a federal judge in St. Paul threw out hundreds of lawsuits against the maker of a faulty heart device, a man entered a nearby hospital to have one of those flawed products surgically removed.
The risky operation went terribly wrong. As doctors extracted the device, a thin electronic cable, from the patient’s heart, a vessel was punctured, causing extensive bleeding. The 33-year-old patient, Mark Turnidge, died Read the rest of this entry »

The Supreme Court decision “left consumers without any ability to get compensation for injuries caused by certain defective medical devices,” said Rep. Henry Waxman, D- Calif., in a statement to the Star Tribune. “The Supreme Court assumed that FDA approval ensures medical devices are safe, but the many recent stories of patients harmed by faulty devices have proven that assumption false.”
Waxman and Rep. Frank Pallone Jr., D-N.J., plan to introduce Read the rest of this entry »

Chicago, Ill.
– I’m just back from Zurich, Switzerland, where I had a chance to get some insights on the Swiss medical device industry. As I was asked to talk about the U.S. medical device industry and entry strategy into the U.S., a good look into the worldwide medical device industry helped me prep for the conference. It’s worth sharing with you.
The medical device industry is composed of a broad array of different types of products. These range Read the rest of this entry »