Monitoring Device Receives FDA Clearance
Smart CapnoLine™ O2, a monitoring device that provides the earliest possible detection of respiratory adverse events that can occur during procedural sedation, received 510(k) clearance from the US Food and Drug Administration in November 2001.

This device by Oridion Systems Ltd, Jerusalem, accurately and continuously measures and monitors a nonintubated patient’s ventilation vital signs by collecting breath samples for CO2 analysis from both the nose and mouth while supplying oxygen to the patient. The uni-junction, a single meeting point for nose and mouth breath sample sources, automatically identifies and selects the nose or mouth breath source providing the highest-pressure sample for a smooth gas flow, and then carries the sample back to the monitor for an uninterrupted waveform during sedation.

“This device meets a critical need for the earliest possible detection of apnea and adverse events, and its exceptional ease-of-use should afford it rapid acceptance by the increasing number of physicians performing procedural sedation outside of the operating room,” says Patricia Hennessey, senior vice president of Field Operations, Capnography Business Unit.

Partnership to Distribute Calorimeter
VIASYS Healthcare Inc, Yorba Linda, Calif, plans to market and distribute MedGem™, the first handheld indirect calorimeter, to hospital and related markets. Manufactured by HealtheTech, Golden, Colo, the device measures respiratory airflow and oxygen consumption and determines resting metabolic rate.;

Respironics Introduces Newest Mask Series
Respironics, Pittsburgh, introduces the ComfortSelect Nasal Mask, the latest addition to its Comfort series of masks, all aimed at increasing patient compliance and comfort when using mask therapy. The ComfortSelect features a dual-layer cushion and adjustable forehead bracket that guards against mask leaks and gives patients a secure, comfortable, and personalized fit. The device is available in small, medium, and small/wide. (800) 345-6443;

3M and Sepracor Announce Collaboration
3M Drug Delivery Systems (DDS) Division, St Paul, Minn, and Sepracor Inc, Marlborough, Mass, announce the manufacturing collaboration for the Xopenex® hydrofluoroalkane (HFA) metered-dose inhaler (MDI). The collaboration will combine Sepracor’s short-acting beta-agonist, Xopenex (levalbuterol tartrate), and 3M’s MDIs.;

New HCPCS Code for CoughAssist
CoughAssist™, a device manufactured by J.J. Emerson and distributed by Respironics, Pittsburgh, will now function under the HCPCS code E0482 (cough stimulating device, alternating positive and negative airway pressure). This will be used in place of the miscellaneous HCPCS code E1399, enabling providers to bill for these devices with less administrative hassle. However, medical necessity documentation is still required.

Medicare classifies code E0482 under the Capped Rental payment category, which covers items that are typically required to be rented for a period of time before the patient is given the option to purchase the equipment. Payment for items in this category may not exceed a period of continuous use longer than 15 months. After this period, the home care provider must continue to supply the item without charge until the medical necessity ends or Medicare coverage ends. For more information about reimbursement information, visit

Radiometer Signs Agreement With MedAssets and Novation
Radiometer America Inc, Westlake, Ohio, and MedAssets HSCA Inc, St Louis, signed a 3-year contract with an additional option year for blood gas analyzers and transcutaneous monitors. This contract extends a preexisting contract between the two companies.

Novation, Irving, Tex, renewed its blood gas contract with Radiometer for 1 year. The contract was also extended to include the point-of-care analyzers NPT7 and ABL77, as well as the TCM400 multichannel transcutaneous monitor.

New Pro-Tech Vice President of Sales and Marketing
Pro-Tech Services Inc, Mukilteo, Wash, announces the promotion of Robert Hezlep to the position of vice president of sales and marketing. He will oversee and develop the sales and marketing departments and will assist in the development of new business opportunities and products.

Telemetry System Reduces Costs of Oxygen Delivery
Chart Industries Inc, Cleveland, announces that its CoolTel division will provide remote monitoring and logistic services to two prominent companies that deliver liquid oxygen to home health care patients. The initial contracts call for the monitoring of 750 liquid oxygen reservoirs.

CoolTel’s medical telemetry system, the O2Guardian™, provides home care liquid oxygen distributors with up-to-date information on the liquid level of their home patients’ oxygen reservoirs. This assures that patients will not experience “run-outs” that cause costly emergency fills. It further enables distributors to make deliveries only when needed.

“HME suppliers have been asking for help to reduce the costs of their oxygen delivery operations and we are demonstrating that telemetry provides the dramatic impact they need in this regard,” says John Hupp, president of CoolTel. “The acceptance of the O2Guardian by some leading health care dealers is a very significant step for the health care industry.”