FDA to Accelerate Approval Process
Innovative respiratory therapy manufacturers may soon be able to gain US Food and Drug Administration (FDA) approval of new devices more quickly and economically.
In response to a reduction in marketing applications and an increase in longer total approval times in some product areas in 2002, the FDA released a plan to expedite the application and approval process.
The report, released January 31 and titled “Improving Innovation in Medical Technology: Beyond 2002,” lists three major goals for improvement: reducing delays and avoidable product development costs by avoiding multiple cycles of FDA review through early communication; improving the quality and efficiency of the review process by adopting a quality systems approach; and facilitating new product development by providing clearer, up-to-date guidance for particular diseases and for emerging technologies.
“Improvement in the rate of single-cycle approval must result from better product development, not lower standards,” says FDA Commissioner Mark McClellan, MD, PhD.
Chad Enters Sleep Market
CHAD Therapeutics Inc, Chatsworth, Calif, has entered into product development and license agreements with AirMatrix Technologies Inc and ACOBA LLC. Together, these companies plan to address potential applications in the rapidly growing sleep therapy market and develop technology to expand CHAD’s home and hospital respiratory product lines.
The joint project should take 12 to 24 months before the initial products are ready for market introduction, CEO Thomas E. Jones says. Funding will most likely come from cash flow from operations.
Overall, CHAD reported increased revenues and net earnings for the third quarter and first 9 months of fiscal 2003 ended December 31. Jones attributes part of the company’s success to domestic sales of conservers and expects earnings to continue to grow for the remainder of this year and in fiscal 2004.
Bloomberg TV Names Respironics “Wall Street Favorite”
In February, a 24-hour business and financial news television network recognized Respironics Inc, Murrysville, Pa, for demonstrating market capitalization of $500 million or more and receiving “strong buy” ratings from top market analysts.
Respironics Inc and four other companies appeared on Bloomberg Television’s show “Morning Call,” which dubbed the companies “Wall Street Favorites.” Interviewed in the segment, Respironics’ COO and Executive Vice President Craig Reynolds spoke about the company’s growth drivers, stock position, performance-to-date, international markets, outlook for growth through the 2003 calendar year, and new C-Flex technology. In addition, Reynolds pointed out that patient comfort and awareness programs distinguished Respironics from the competition.
| BOC, NJ Hospital Network Unite to Develop Oxygen Systems BOC, Murray Hill, NJ, an industrial and medical gases, vacuum technologies, and distribution services company, and Atlantic Health System, a nonprofit health care system in New Jersey, have joined to develop technology to improve the dependability and safety of hospital liquid oxygen storage and delivery systems. As part of the cooperative agreement, BOC will supply the Atlantic Health System’s four northern New Jersey hospitals with medical oxygen and liquid oxygen storage, monitoring, and vaporization technology. Colorado Hospital Installs “The new Nellcor OxiMax N-595 pulse oximeters provide accurate patient monitoring and have the ability to read through patient movement,” says Yvonne Young, assistant clinical manager and clinical educator for pediatrics and the pediatric intensive care unit at Memorial Hospital. “There has been a decrease in the number of false alarms. Now, when an alarm goes off, we know it is real.” Duke To Hold Pediatric |
