-
One day after Boston Scientific (Natick, Massachusetts) emerged victorious in its bid to acquire Guidant (Indianapolis) for about $27.2 billion, the FDA warned it of company-wide quality failures that could possibly hold up future product approvals.
-
The first steps toward commercializing a product require: one, discovering and developing the product and, two, identifying the best application for that product. And this second often turns out to be the more difficult.
-
Abiomed (Danvers, Massachusetts) said InEK, the governmental authority for reimbursement in Germany, has granted the highest approval level available for the company's Impella Recover devices. The new German reimbursement standard will apply to Abiomed's Impella Recover LP 2.5, Impella Recover 2.0, Impella Recover RD and Impella Recover LD, which are available in Europe under the CE mark.
-
Ingen Technologies (Calimesa, California), manufacturer of OxyAlert, OxyView and Secure Balance, said that TSI Medical has agreed to distribute OxyView in North America. OxyView, patent pending, is a pneumatic gauge that provides visual safety warning of oxygen flow for patients in the hospital, surgical room, outpatient therapy, nursing homes and emergency response facilities.
-
St. Jude Medical (St. Paul, Minnesota) reported the FDA approval and market launch of its newest platform of pacemakers, the Victory family of devices. The product will be immediately available in the U.S. and Europe.
-
-
A potentially revolutionary new feature may soon be added to the Medtronic (Minneapolis) cardiac resynchronization therapy defibrillator (CRT-D) line if a new trial being conducted in the U.S. and other sites around the world proves successful.
-
Continuing a strong push into the device realm -- and thereby further expanding its opportunities for innovative device/drug combinations Angiotech Pharmaceuticals (Vancouver, British Columbia) has unveiled plans to acquire privately held American Medical Instruments Holdings (AMI; Lake Forest, Illinois), a company of several manufacturers of medical devices.
-
AGA Medical (Golden Valley, California) has joined the growing ranks of companies evaluating the benefit of patent foramen ovale (PFO) closure for the treatment of migraine, saying it has received conditional approval from the FDA to initiate a new study under an existing investigational device exemption to examine the possible connections between migraines and PFOs.
-
The Heart Failure Society of America (HFSA; Minneapolis) last month issued its new guidelines for "living with and treating" heart failure (HF), and in so doing promised the expansion of recommendations concerning the use of medical devices to treat HF. The lengthy list of protocols does provide greater focus on devices than in the organization's guidelines last issued in 1999 -- but probably not as much as device manufacturers in this sector would like.
