A medical alert system developed by wireless communications company Ascom has received 510(k) clearance from the U.S. Food and Drug Administration, and now the company is gearing up to bring the new offering to its installed customer base of nearly 1,200 U.S. hospitals.
Ascom’s ClinicalConneX system already provides voice and messaging services in hospitals. But the company’s system now has FDA clearance to work with patient monitoring systems to deliver medical information to clinicians’ pagers, mobile handsets or other devices. The wireless communications focus of the company comes from its legacy as the business unit of Swiss telecommunications giant Ericsson (NASDAQ:ERIC). Switzerland-based Ascom (SWX:ASCN) acquired the Ericsson operation in 2000, which had carved out a business providing wireless communications systems to a range of business customers including hospitals, manufacturing firms, retailers and hotel operators.
Ascom US CEO Chad West said that about six years ago, the company decided to focus its efforts on hospitals. Using unlicensed parts of the wireless spectrum, Ascom offers hospitals a system that can deliver voice and messaging communication to mobile devices. Rex Hospital in Raleigh, North Carolina is among the hospitals using Ascom’s system for such communication. Hospitals now comprise about 90 percent of Ascom’s North American sales.
Much like other telecommunications companies, Ascom saw that there are business opportunities in offering new services in addition to basic voice. Through its experience in the hospital market, West said Ascom realized it could also work with patient monitoring systems by transmitting medical alerts in real time or near real time. The company filed with the FDA an application for 510(k) clearance. Ascom made the filing even though the FDA was still working on a new Medical Device Data Systems, or MDDS, rule about remote healthcare devices. Previously, such devices had been classified as class III devices requiring a higher level of FDA scrutiny. Under the new MDDS rules that came out in February, these devices are classified as class I devices. West says that other vendors in this space had been waiting for the MDDS rule to come out before moving ahead with their offerings, but Ascom made a gamble that its system would be allowed under the news rules.
“We’ve got a bit of a first mover’s advantage, for a little while anyway,” West said.
West said that Ascom’s medical alert offering, Cardiomax, is able to deliver directly to caregivers any alerts triggered from a patient’s bedside monitors. The offering will be an upgrade that can be added to Ascom’s ClinicalConneX systems already in place in hospitals. But West said that the new offering will also work with hardware provided by competitors Cisco Systems (NASDAQ:CSCO) and Polycom (NASDAQ:PLCM).
Ascom is not the only North Carolina health IT firm developing alert systems for U.S. hospitals. Last week, Raleigh, North Carolina-based Axial Exchange raised $1.5 million in a series A round. The company is developing software that can send real-time electronic alerts over the Internet. Physicians can receive the messages on their computers or smart phones.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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