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Boston Scientific Corporation (BSC), headquartered in Marlborough, Massachusetts and incorporated in Delaware, [2] is an American biotechnology and biomedical engineering firm and multinational manufacturer of medical devices used in interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular ...
Biocompatibles International plc was a medical technology company in the field of drug-device combination products. It was acquired by BTG plc in 2010, [2] which was, in turn, acquired by Boston Scientific in 2019. [3] [4] Approved oncology products were supplied and marketed from facilities in Farnham, Surrey, UK and Oxford, Connecticut.
Shares of the medical device maker rose 1.5% in afternoon trading. The approval makes the device, branded Agent, the first drug-coated balloon catheter in the U.S. to treat coronary in-stent ...
A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number. Statutory standards for BLA approval are largely the same as those for New Drug Application approval. According to 21 CFR 600.3, FDA interprets "potency" to include effectiveness of ...
Boston Scientific forecast a full-year profit on Wednesday that was largely ahead of analysts' estimates and said the U.S. health regulator has approved its heart device, sending the company's ...
The FDA has given 510(k) clearance for Boston Scientific Corp's (NYSE: BSX) Exalt Model B single-use bronchoscope for use in bedside procedures within the intensive care unit and operating room.
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