The FDA is easy. Let’s talk CPTs.
 “You are not going to get paid for cool ideas,” IntelliDOT CEO and founder of CardioNet James Sweeney told a group of wireless health entrepreneurs at the Wireless Life Sciences Alliance event last month. “You are not going to get paid for saving lives. You are not going to get paid for anything unless you can prove that you can save them money.”
Sweeney’s words clearly still echo in the halls of CardioNet’s Conshohocken office building. The company just announced a more modest outlook for its full 2009 fiscal yearbecause it anticipates lower commercial reimbursement rates for its MCOT wireless remote monitoring for cardiac arrhythmias technology. The company expects revenues for the year to be in the range of $156 million to $160 million now instead of its previously predicted $170 million to $175 million revenue range.
“In the world we’re moving into, more than ever, if you can’t justify the cost benefits, then you will fail,” Sweeney told the crowds at WLSA. “In my view, getting the FDA’s approval is not nearly as hard as getting the CPTs and insurance reimbursement approvals.”
CardioNet can certainly claim wireless health pioneer status for getting a CPT code and gaining reimbursement approvals, but anyone who has played classic video games knows the pioneer’s trail is fraught with countless obstacles. Maintaining reimbursement dollar amounts is clearly one of them.
“CardioNet intends to continue its previously announced investments in its sales and marketing organization, product development and clinical research programs,” CEO Randy Thurman said in a statement. “Other areas of spending will be curtailed and restructured.”
Financial blog PhillyDeals wondered: What’s left to cut after sales, marketing, product and research? (Maybe future acquisitions?)
“[CardioNet] just completed training for its expanded sales organization and expects to have over 140 experienced cardiology account executives fully deployed beginning in the third quarter of 2009,” Thurman said in a statement. “CardioNet believes this will be the largest sales organization in the world dedicated to wireless healthcare. The second half of the year will also be marked by the company’s entry into the hospital and cardiac thoracic surgery markets.”
Other wireless health start-ups looking to follow CardioNet’s trail, listen up: Once you have sorted through the increasingly complicated regulatory framework in this emerging industry you have the reimbursement kerfuffle to look forward to. If Sweeney is to be believed, the second is the road less travelled by, but it could make all the difference.
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Glucose Buddy inks deal with Roche
MYLEstone Health, developer of the Glucose Buddy iPhone app, is working with Roche Diagnostics’ Accu-Chek to add its educational program to the Glucose Buddy diabetes management app. Even though the addition of Accu-Chek’s educational program to the iPhone app is a far cry from meter integration, MYLEstone co-founder Matthew Tendler told mobihealthnews, it is a step in the right direction and it will bring substantial value to people with diabetes and iPhones.
In early March one of the other big four meter makers was interested in working with us, but given Glucose Buddy’s availability exclusively on the iPhone, the company saw a limited opportunity, Tendler said. A few weeks later Apple invited LifeScan on-stage at an iPhone event to demonstrated a Bluetooth-enabled blood glucose monitor. Tendler said that the next morning everyone held meetings to discuss how they could break into the iPhone.
“What we are creating [with Roche] will take us probably two months total,” Tendler said. “They have told me that if they were doing this in-house it would take over two years [to reach market].” Tendler said he expects the Accu-Chek program to be included in Glucose Buddy by the end of the summer. Continue >>
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Sprint demos wireless health services
At last week’s “mHealth Solutions and Policy Forum” hosted by the wireless industry association CTIA, wireless carrier Sprint was the only carrier to participate and demonstrate a few of the healthcare solutions its wireless network currently supports.
During the event, Sprint demonstrated these mHealth services:
REDFLY Mobile Companion, developed by Celio, is a 2 lb device that acts “as a smartphone terminal and extends all information from the smartphone to the big screen and keyboard, allowing physicians to use their smartphones like a laptop,” according to the carrier. The REDFLY Mobile Companion links to smartphones via USB cable or wireless Bluetooth connection and extends the Windows Mobile interface.
mVisum, which is a “mobile application that allows physicians to securely receive, view and respond to patient data recorded at the point of care” (POC) on their smartphones. The mVisum STEMI Alert System allows transmission of ECGs and other patient data directly to a physician’s Blackberry to reduce the amount of time it takes for a diagnosis to help lower door-to-balloon time, according to the company’s site.
Creative inPerson, which is a video conferencing application that enables communication between healthcare providers and patients and costs around $700 per system.
While these products demonstrate that wireless carriers have been supporting the healthcare industry for some time — 30 years in Sprint’s case, according to the carrier — that support is largely helping physicians and hospital staff become more efficient. To date, the opportunity to leverage the mobile phone and other wireless technologies to further the rise of the empowered patient is an opportunity that third party applications have done more to realize than the wireless carriers themselves.
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iPhone exec joins VC to invest in mHealth
Apple’s senior director of worldwide product development for the iPhone recently left the company to join venture capital firm Opus Capital as a general partner. Bob Borchers, 43, previously worked at Nokia and Nike before joining Apple in 2004.
Borchers told VentureWire he won’t be leaving the wireless industry: his focus at Opus will include wireless and medicine as well as mobile marketing technologies.
Opus currently has four partners and more than $1 billion in committed capital. It raised its last fund, which has $280 million in assets, in 2006.
At Apple’s special sneak preview of iPhone OS 3.0, Scott Forstall, SVP of iPhone Software at Apple declared: “Now here’s a class [of services] that we think will be really interesting: medical devices.” A few weeks later, Apple’s Mark Wilson reportedly said that “The medical community is flocking to the iPhone” during his remarks at Apple’s Worldwide Developers Conference.
For more read this report from the San Francisco Business Journal.
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| Sequoia Capital invests in eCardio
Texas-based arrythmia monitoring provider eCardio announced today an undisclosed minority investment from Sequoia Capital. This investment marks the first round of institutional funding for the company since its founding in 2004. Sequoia has previously invested in Apple, Cisco, PayPal, Google, Oracle, Yahoo, YouTube and other well-known tech companies.
“eCardio has experienced tremendous growth by meeting the needs of physicians and the patients they serve,” Sequoia Capital’s Scott Carter stated in a company release. “We are excited to partner with a company that provides doctors with the most advanced cardiac diagnostic and monitoring solutions.”
eCardio has some big competition in the cardiac remote monitoring business: CardioNet, LifeWatch and Intelli-Heart are just a few of its rivals. CardioNet has already gone public and attainted reimbursement for its services, while LifeWatch has grown its business and recently cozied up to Verizon Wireless in an exclusive deal.
For more on the eCardio news, read the company’s release.
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Wireless sensors for faith-based nursing facilities
Wireless sensor-powered remote monitoring company WellAWARE recently inked deals with two large faith-based nursing charities just weeks after the company launched, according to a report over at ZDNet Healthcare. The deals come after five years of development and pilots. A total of 60 facilities currently have WellAWARE installed.
When a resident’s movement and activities differ from the norm, the system pushes an alert to caregivers’ mobile phones.
The company uses proprietary wireless sensors for its system, but is evaluating the ZigBee standard for future components, especially since the current system only uses sensors to track patient’s movement throughout their residence. ZigBee might make it easier to add blood pressure monitoring and blood glucose monitoring application, CEO Jeff Noce said. The proprietary sensors can run up to 6 months before a battery change is required.
The company’s first two official launches are with the Evangelical Lutheran Good Samaritan Society and Hastings.
Noce told ZDNet that Intel and GE’s recently announced plans to enter this market will only help to legitimize WellAWARE’s progress to date.
For more, read the article from ZDNet
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| ReachMD: 60,000+ downloads for CME app
XM satellite radio’s ReachMD recently launched a new iPhone application that includes all of the continuing medical education (CME) offerings from its previous app plus a live stream of the XM radio station for free right from the user’s phone. During its first week available in the iPhone AppStore, ReachMD MedicalRadio had 3,000 downloads, CEO Gary Epstein told mobihealthnews. The original ReachMD CME app has had more than 60,000 downloads, Epstein said.
“This new app is holistically all of ReachMD. It includes the way you would listen to the radio in your car, archive programming and some rich search functions. If you are a doc and only want cardiology content, you can build your profile on the app so it only pushes cardiology programming to you or whatever content in your area of interest.”
While the new app does include all of the functionality of the original one, Epstein said the company has no immediate plans to remove the first one — it’s just a more streamlined CME app and it has proven quite successful.
“I have an instinct that may just be a bias from my days at the AMA, but I know docs like things spoon-fed and easy,” Epstein said. “Docs are very efficient minded so they may prefer the original. Also, what harm is there for us to keep the other app up?” Continue >>
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Guest Column: E-Medicine’s time is coming
E-medicine will have a wide, growing and very important place in the delivery of health care in the years to come. By e-medicine I refer to simple approaches like email all the way to the very complex telesurgery done remotely across continents with a robot.
There are many hurdles, not the least of which are funding and reimbursement. For example, most physicians do not like to use email with their patients because the time invested is not reimbursed by insurance. Too bad because email can save visits to the doctor, speed up diagnosis and therapy and reduce the overall cost of care while improving quality. The same goes for wireless devices such as a digital scale used by the patient with heart failure. Every morning his weight is transmitted to the doctor’s office. An algorithm notifies the staff if the weight is rising, perhaps suggesting the need for a medication modification. This can prevent an office visit or even a trip to the emergency room or admission to the hospital. Similar wireless technologies can be used for observing blood sugar among diabetics; but again, no reimbursement so these technologies are not yet finding their maximum value. Continue >>
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Wireless device/implant help quell Parkinson’s
U. of House works on wireless sensors: University of Houston and the Abramson Center for the Future of Health are designing an in-home health system for vital sign monitoring and location tracking. For about $1,000 an entire house could be outfitted with the system, which could then alert caregivers via their smartphones when a patient is in need. For movement tracking, patients will have to wear a sensor the size of a quarter on a piece of their clothing, while vital sign monitoring requires a sensor attached to the patients skin like a band aid. More
UK leveraging mHealth for osteoarthritis: UK researchers just received an $18.2M grant for rehabilitating patients with osteoarthritis and slowing its development to delay joint deterioration. Some of the funding will go toward developing wireless sensors that enable patients to maximize the effects of their rehabilitation exercises. When patients wear the sensors, doctors can monitor knee motions and correct wrong movements if necessary. More
Relief for Parkinson’s related involuntary movement? Orlando Health neurologist Dr. Alex Gonzalez can now use a wireless device, a bit larger than a PDA, to remotely adjust an electronic implant in a Parkinson’s patient to quell his involuntary movements as they arise. More
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Understanding mHealth regulation: FCC & FDA
Wireless technology has long been a part of medical devices. The recent introduction of more sophisticated wireless phones and the deployment of wireless broadband networks has sparked the development of new “mHealth” (mobile health) applications and services that enable medical professionals to monitor patient data and help patients manage their condition and adhere to a treatment regimen. New applications in the pipeline will empower patients by aiding in early detection and allowing for home-based diagnostic tests.
mHealth raises policy issues within the domain of at least two federal agencies-the Federal Communications Commission (FCC) and Food and Drug Administration (FDA). The FCC has jurisdiction over the use of the electromagnetic spectrum used by cellphones, Wi-Fi routers, and similar devices. It also has jurisdiction over the spectrum used by devices that are attached to or are implanted in patients, measure vital signs or other medical information, and transmit that information wirelessly elsewhere. The FDA has jurisdiction over medical devices and must approve the medical devices before they are made available to the public.
The FCC is currently considering whether to make more spectrum available for certain types of medical devices. The FDA has already determined that some mHealth software (applications) loaded on to cellphones constitutes a medical device, and is now beginning to wrestle with the question of whether the mobile phone itself may become a medical device, requiring regulation by the agency, when it is running these types of applications. In this alert, we provide an overview of the FCC’s and FDA’s respective roles regarding mHealth and the current mHealth issues before these agencies. Continue >>
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Five mHealth start-ups that snagged VC in 09
This year the emerging wireless health industry has enjoyed a boon of publicity and in some cases hype, but it’s also been a bright spot for venture capital investment, too. Here are five mHealth start-ups that received venture capital investments in 2009. Their products range from wireless implantable neurological devices to fitness-tracking wristbands and waiting room tablets. Continue>>
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Apple patent for wireless remote monitoring
Apple-focused publication MacNN’s patent editor has uncovered a recently granted iPhone-related patent that covers wireless remote monitoring of vital signs. The first patent MacNN found is for the “technological make-up of a monitoring device” and a “transponder that reflects event data,” which by example is presented as a mobile phone – heart rate detector system as well as a mobile phone – weight sensor, temperature sensor or chemical sensor system.
A monitor device preferably includes an adhesive strip that provides for convenient attachment of the device to an object or person, the patent filing states.
Another use case the patent describes is an in-home baby monitoring alarm system that includes a Band Aid-like sensor that would be attached to the child’s foot. The device then synchs to the baby’s body movement, breathing sounds, pulse or respiratory rate via the sensor. The device also sounds alerts and alarms when the baby’s heart rate, respiration or pulse are absent.
Apple files many more patents than they do launch products, so these patents should not be taken to mean a related product is forthcoming. Clearly, though, Apple has its eye on the wireless remote monitoring market more so than it seemed previously.
For more read this article from MacNN.
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Slideshow: Healthcare Unbound images, quotes
Last week at the Healthcare Unbound conference in Seattle, Washington about 150 health industry thought leaders convened to discuss electronic medical records and wireless health services.
Scroll through this slideshow of images taken from the show in Seattle for some of the memorable quotes and points made during the course of the event last Monday and Tuesday.
Play Slideshow
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The World Health Care Congress Leadership Summit on Wireless Health
July 27-28, Boston
This two-day Summit convenes policy-makers, payers, providers and medical group practices from across the nation to discuss business and clinical opportunities for integrating mHealth, Remote Monitoring and Telehealth solutions into existing care systems. Real-life, case studies and the results to-date from pilots at several leading provider organizations will be shared.
Save $300! Enter promo code JXS955 at registration!
Register here
ATA Mid-Year Meeting
Sept. 24-25, Palm Springs
The Third Annual ATA Mid-Year meeting is one great meeting combining two great tracks & showcasing the latest in products and services:
Track I:
Cutting Edge and Off-The-Shelf Technology: Making the Right Decisions
Track II:
4th Annual Pediatric Telehealth Colloquium
Register here
CTIA WIRELESS I.T. & Entertainment
October 6-9, San Diego
No matter what your business is – healthcare, entertainment, fleet management or financial planning – wireless can transform how you do business. International CTIA WIRELESS I.T. & Entertainment brings this possibility to life. With a focus on applications, network architecture and technologies such as LBS, machine-to-machine and WiMAX (just to name a few), this international event brings a community of users, carriers, developers and manufacturers together to generate dialogue, share ideas and debate the economics of MOBILE BUSINESS.
Register here
Health 2.0
October 6-7, San Francisco
With nearly a hundred speakers and plenty of new healthcare demos and technologies on display on stage and in the exhibit hall, you’ll get a sweeping overview of the ways that information technology and the web are changing healthcare. We’ll be looking at the “traditional” Health 2.0 areas like vertical search, online social networks and tools for consumers. But the conference will also be focusing on how new technologies are connecting patients and clinicians, and examining the impact of Health 2.0 technologies on patients lives.
Register here
TEDMED 2009
October 27-30,
San Diego
The fifth in a series created by Marc Hodosh and Richard Saul Wurman, TEDMED celebrates conversations that demonstrate the intersection and connections between all things medical and healthcare related: from personal health to public health, devices to design and Hollywood to the hospital. Together, this encompasses more than twenty percent of our GNP in America while touching everyone’s life around the globe.
Register here
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