Pressure Increases on FDA to Bar Code Medical Devices
The AHA News reports that seven members of the House of Representatives are requesting a written response from FDA Acting Commissioner Lester Crawford concerning the FDA's plan to require the bar coding of medical devices. After thinking about this, it doesn't seem so crazy if applied to implantable and single use devices like pacemakers, catheters and stents. Bar coding beds, IV pumps and more durable medical devices is still crazy.
Datascope Reports Q3 2005 Results
Datascope took another hit in their vascular closure device business in the quarter ending March 31, 2005. Sales came in at $96.1 million (vs. $89.9 million for last year), but would have been 1% behind last years performance without a $6.1 million Panorama backlog and favorable exchange rates kicking in another $3.6 million. Overall, gross margins are lower with R&D and SG&A expenses higher than last year.
Sales of patient monitoring products were $44.7 million in the third quarter, 17% above last year (mostly due to the Panorama revenue mentioned above). Increased monitor sales also contributed to the increase. Panorama sales averaged over the last 3 quarters are nearly equal the demand of the OEM-based (i.e., GE's DataCritical acquisition) networks sold over the comparable period last year — good performance for replacing a major product in a mature market. The third quarter saw the release of “Phase 3″, a Panorama software release that improved arrhythmia detection performance. Also released in Q3 was the new Duo vital signs monitor (sadly, no connectivity features are mentioned on their web site — but there's probably an RS232 serial port). Duo has a cool looking ergonomic stand too. Datascope is targeting Duo at the low cost spot vital sign monitor market, estimated at $35 million annually.
Cardiac assist product sales increased by 6% to $35.7 million for the quarter, riding on continued strong sales of their CS100 balloon pump, and the introduction of the Linear 7.5 Fr. IAB in January.
Interventional products were down at $6.6 million compared to $9.4 million in 2004 — this mostly due to declines in vascular closure device sales. Datascope released two new products in this category last year, and has two more in the pipeline to reverse the trend.
Datascope seems bullish on their near to mid term prospects, having just repurchased 29,000 shares of stock for $1.1 million. The company has a $40 million stock buy back program, and has spent just over $35 million so far.
Its Been a Crazy Week
I've been collecting some interesting things that have been going on this week, as well as some other items that have come to my attention. I'll be posting this evening and through the weekend to catch up, so check back!
