The Food & Drug Administration today announced a program for improving the safety and efficacy of automated external defibrillators. The federal watchdog agency said it’s received 28,000 reports of AED failures in the last five years, yet 300,000 Americans could benefit from treatment from the devices every year. AEDs are designed to treat cardiac arrest […]
Opto Circuits (India) Ltd. (BSE:532391) entered into a merger agreement with Cardiac Science Corp. (NASDAQ:CSCX). The Bangalore, India-based medical device developer plans to acquire Cardiac Science in an all-cash tender offer for $2.30 per share, a 10 percent premium over its Oct. 18 closing price and a 30 percent premium on CSCX’s average closing price […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Cardiac Science Corp. (NSDQ:CSCX) will replace 24,000 automated external defibrillators implicated in a November 2009 recall. The Bothell, Wash.-based company’s Powerheart, CardioVive, Nihon Kohden and GE Responder AEDs have electrical component flaws that may cause device failures. The flaws could not be remedied through software patches, according to the Food & Drug Administration. The company […]
The Food & Drug Administration issued warnings to Millipore Corp. and Cardiac Sciences Corp. and a Class I recall to Synthes USA. The FDA has concerns about one company's diagnostic equipment, and malfunctioning defibrillators and vertebral implants from the other two companies.