Regulators in the UK and Hong Kong issued warnings on CircuLite’s Synergy circulatory support system after at least 3 reports that the devices’ inflow cannulae fractured.
Cardiovascular medical device maker CircuLite won conditional FDA approval for its flagship device, the Synergy circulatory support system. The company claims that this device, roughly the size of a AA battery, is the world’s smallest implantable heart pump.
The federal watchdog agency has granted conditional approval for Investigational Device Exemption (IDE) status. Synergy is an implanted device meant to halt symptoms for chronic heart patients by improving blood flow during a heart failure.
The European Union granted CE Mark approval to a pair of medical device companies, CircuLite and NeuroSigma, for their technologies designed to treat heart failure, epilepsy and depression.
Merck Global Health Innovation Fund will invest up to $17 million in medical app maker Physicians Interactive Holdings. The financing includes $8.5 million up front, but could double if the mHealth marketer meets Merck’s milestones.
The Marlborough, Mass.-based company plans to use the Merck funds to grow "4 key products," including its flagship medical resources app Skyscape.
CircuLite Inc. landed $30 million in an oversubscribed Series D financing round led by McAndrews & Forbes Holdings Inc. and Forbion Capital Partners.
The Saddle Brook, N.J.-based company will use the funds to support the European commercial launch of its Synergy circulatory support system and to fund an investigational device exemption pilot study in the U.S.
CircuLite touts Synergy as the world’s smallest implantable heart pump, saying it’s roughly the size of a AA battery. The company expects to receive European Union CE Mark approval for the system during the first half of 2012.