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Abbott Laboratories continued to make progress in its vascular products business in the first quarter of 2005 and indicated in a recent call with financial analysts that a new carotid stent trial has the potential to significantly expand the company’s market share in that area.
An FDA advisory panel recommended approving Mentor’s new silicone-gel breast implants a day after rejecting rival company Inamed’s application, citing Mentor’s slightly lower rate of rupture and its longer-term studies.
Canon shareholders approved an expansion to the company’s articles of incorporation March 30 to include the commercialization of DNA chips, classified under “production and sale of pharmaceutical products,” as a way for Canon to enter the biotechnology field.
Boston Scientific has completed enrollment in the postapproval trial for its Enteryx procedure to show real-world clinical outcomes, safety data and efficacy for patients suffering from gastroesophageal reflux disease (GERD) symptoms.
Stent manufacturer Conor Medsystems has filed a new patent lawsuit in Australia against Angiotech, according to company officials, who last week provided an update on Conor’s legal situation.
The Justice Department issued subpoenas to several of the industry’s largest orthopedics manufacturers last week seeking information concerning payments to doctors who use the companies’ products.
In addition to treating movement disorders such as Parkinson’s disease, essential tremor and dystonia, Medtronic will now be able to treat obsessive compulsive disorder (OCD) in a select subset of patients due to a recent FDA humanitarian use device (HUD) designation.
Certain models of HeartSine Technologies’ samaritan Automatic External Defibrillators (AEDs) may shut down before delivering a shock, which could result in a delay in treatment or the death of a viable patient, the FDA warned in a MedWatch alert released last week.
In yet another indication of how the evolution of combination products is changing the regulatory landscape, the FDA is seeking advice on whether it should consider reviewing -- and possibly approving or clearing -- a new product labeled for use in conjunction with an already approved product of a different type.
In yet another indication of how the evolution of combination products is changing the regulatory landscape, the FDA is seeking advice on whether it should consider reviewing -- and possibly approving or clearing -- a new product labeled for use in conjunction with an already approved product of a different type.