Record Quarter for Medical Device Funding
According to this story in the San Francisco Chronicle, the medical device market is setting records for venture capital investments.
Underscoring the expanding investor interest in life sciences, deals for
companies making medical devices reached a record of $1.08 billion for 96
deals, a 60 percent jump from the level of funding in the fourth quarter of
2006.
“It was the strongest quarter ever for biotech and medical devices since
we started keeping numbers 10 years ago,” said Mark Heesen, president of the
National Venture Capital Association, which published the study together with
PricewaterhouseCoopers based on data from Thomson Financial.
The biggest device investment lately is the $110 million bridge financing raised by CardioNet.
Defibtech Lifts Ship Hold
Defibtech has released new software to upgrade recalled devices, and has lifted their ship hold on the Lifeline and ReviveR brand automated external defibrillators (AEDs).
recall. The new software also includes a free upgrade of the unit to
the latest 2005 AHA Guidelines. Customers who currently have Defibtech
AEDs deployed in the field do not need to send their AEDs to Defibtech
to correct the issue, rather, the units can be easily upgraded in the
field, there where the units are deployed. The upgrade procedure is
very simple and takes only a few minutes to complete.
The recall was announced on March 7, so they were on ship hold for about a month – not a fun time for Defibtech, I'm sure.
USB Implementers Forum Creates Healthcare Working Group
The industry group responsible for the advancement and adoption of USB technology (warning: obnoxious sound track) has created a health care working group. Apparently patterned on the Continua Health Alliance approach, the group is targeting health and wellness, disease management and aging independently market segments. Noted members are also all Continua members: Cisco, Intel, Nonin, and Welch Allyn. From the press release (pdf).
In a previous post, the security threats posed by USB devices to personal health records (PHRs) were described. Many medical devices today are based on Windows CE because of the many communications services built into the operating system. A USB drive can carry executable code that could install a Trojan horse program or corrupt data. How (or if) medical devices will mitigate this risk will be interesting to see.
The good news is that USB connectivity is pretty crude and poorly suited for most medical device connectivity applications and should be eclipsed by Ethernet and wireless LANs.
Pictured right is a kanitume USB drive.
[Hat tip: Health Data Management]
Disruptive Continuous EEG Monitor for ICU
Continuous EEG monitoring is a useful diagnostic tool for identifying a number of important neurological problems and to guide therapy. The problem with continuous EEG monitoring is that it requires specialized techs and consulting neurologists. Last November (2006) Stellate introduced a continuous EEG monitor for the ICU with an impressive array of connectivity features (press release). From an MD Buyline write up:
for operation by ICU staff, while incorporating advanced EEG analysis and
display options. Mindful of space limitations in the ICU environment, the
platform features a small form factor panel PC with touch screen controls.
Vita ICU provides several customizable trending options including Cerebral
Function Monitor display, automatic quantification of Burst Suppression
activity and Color Density Spectral Array that each facilitate quick
identification and review of critical events. Sophisticated seizure detection
programs help capture seizure information that would otherwise be difficult to
identify by physical observation. E-mail and pager alerts can be programmed
for notification of attending physicians while they are away from the ICU. The
networking and remote access feature enables review and intervention when
needed by EEG technologists or clinicians without the need for them to be
physically present in the ICU.
In addition to alarm management, the system provides remote alarm notification via email or pager. Alerts can be defined based on trended values, and all data is stored in a SQL database. The system also supports a webcam video camera for streaming video synchronized to the EEG signal to consulting physicians.
Let's summarize. A continuous EEG monitor designed to be set up and operated by ICU staff rather than a specialized tech, with connectivity to provide immediate remote access to retrospective and near real time patient data for consults. Sounds promising, although it seems they may have made a few newbie connectivity mistakes. Pictured right is the Vita ICU system.
FDA Lifts Warning on Guidant ICDs
The FDA has lifted the December 2005 warning letter on Guidant implantable cardioverter defibrillators (ICDs) that suspended Boston Scientific's introduction of new Guidant products. It took Boston Scientific a full year to retool their quality systems and backfill required documentation. The FDA reinspected the Guidant facilities last November and December, rending their decision almost 4 months later. From the Boston Globe story:
Scientific received from the FDA in January 2006. That letter applies
to its drug-coated stent business and the rest of the pre-Guidant areas
of the company. Executives have said they do not expect the warning
issue to be resolved until the second half of this year. Until then,
the company will be prevented from receiving agency approval of any new
models of drug-coated stents.
Congrats to Boston Scientific. Pictured right is the Guidant Contak Renewal ICD.
