Massachusetts-based medical device maker EarlySense received FDA clearance for its oximetry-integrated bedside system and central display system to help the clinicians provide a higher level of supervision for post-surgical patients.
MASSDEVICE ON CALL — A series of high-profile drug and device recalls has locked the FDA in defense mode, making standard review processes more difficult, venture capitalists say.
The unpredictability and threat of longer review times may be making investors more wary of putting their faith and their dollars into med-tech.
Amid lawsuits concerning its Pinnacle metal-on-metal hip implant, Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics won U.S. Food & Drug Administration clearance for its next-generation Pinnacle ceramic-on-metal hip implant.
Ceramic-on-metal is a novel combination in the hip implant market, having undergone two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing as part of the clearance process.
EarlySense Ltd. announced its intentions to open its U.S. headquarters in Massachusetts.
The move is a "direct result" of Mass. Gov. Deval Patrick’s March trip to Israel, where he met with EarlySense officials, according to a Mass. Life Sciences Center official.
Israeli medical device company EarlySense Ltd. announced today that its EverOn Central Display Station — which accompanies its EverOn Touch patient monitoring system — was cleared the Food & Drug Administration.
The 510(k) clearance covers the ability to collect real-time vital sign information from up to three dozen EverOn bedside monitors and display the information on a computer screen at a nurse’s station. The information also is displayed on large LCDs on medical or surgical floors, enabling clinicians to continuously monitor patients.
By Mary Vanac
Ramat Gan, Israel-based medical device company EarlySense Ltd., which recently closed a $13 million fund-raising round, received Food & Drug Administration clearance to sell its EverOn Touch patient monitoring system in the United States.
EverOn is a patient supervision system that goes underneath a hospital bed mattress. The device measures patients’ vital signs, such as heart and respiration rates, as well as movements to alert caregivers about their medical condition.