ECGI(.058)...acquisition, medical device clearances.....
ECGI's acquisition of a US-based data monitoring center is expected to occur this Friday (as per the 8-K filing).
In addition to the marketing clearance from Health Canada that the company received for its NowCardio product, ECGI is expecting to receive at least two other marketing clearances before the end of 2016 (United States and Europe).......
As part of the Event Cardio-NCMC deal, the center will serve as the company’s U.S. data monitoring hub. NCMC, an FDA-registered independent diagnostic testing facility, already provides ECG support services for physicians, hospitals, scanning services and home health care agencies. It boasts of about 900 customers and projects sales of $2.5 million this year.
To help in this monitoring operation, Event Cardio plans to use the NCMC, a 30-year-old organization that is located in Glenelg, Md., “as a vehicle to launch our product,” following FDA clearance, Bentivoglio told Medical Device Daily. He added that talks between the two had been ongoing for about six months. Event Cardio plans to use the facility to monitor data and detect heart problems in patients performing their day-today activities.
The company intends to submit its 510(k) application for the Nowcardio system by the end of July.
Event Cardio plans to keep and enlarge the NCMC staff, expanding its sales force to 25 states by the end of the year and all 50 states by the end of 2017. Richard Owsik, president, CEO and co-founder of NCMC, will stay on board as a consultant. Joseph Hashim, formerly with NCMC, will become vice president of sales and marketing at Event Cardio.
Richard Smith, chief technical officer at Event Cardio, told Medical Device Daily that the company is aiming to move its remote monitoring model globally, and already has gained ground in Australia and the Asia-Pacific region. Bentivoglio added that the company expects the CE mark within 90 days.
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