While neither warning is classified as a recall, the FDA has provided additional information for the two products. Boston ...

The FDA said some of Boston Scientific ’s Endotak Reliance defibrillator wires can become calcified, which may stop the ...

The specifics surrounding the incidents involve the access systems used during implantation procedures for sedated patients ...

The FDA is reviewing Boston Scientific's defibrillator leads after reports of rising shock impedance and 16 related deaths.

The FDA has issued an early communication to warn of updated instructions for use for certain Boston Scientific Watchman access systems.

The update covers devices used in procedures to implant the company’s Watchman heart device.

The FDA has issued an alert regarding a safety concern with certain Boston Scientific defibrillator leads used in implantable cardioverter defibrillators. The affected models include Endotak Reliance, ...

Boston Scientific Corporation (NYSE:BSX) is one of the most profitable growth stocks to buy according to billionaires. On ...

A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the ...

The FDA has issued an alert about a potentially high-risk issue involving models of Boston Scientific’s Watchman Access Systems, which are used to provide vascular and transseptal access during ...

Shortly after obtaining a green light from the FDA, SetPoint Medical announced $140 million in new funding to juice the ...

The shares of biotech companies fell after news that ousted regulator Vinay Prasad is set to go back to the US Food and Drug Administration. Prasad had previously overruled his own scientific review ...