Archives for February 2008
Expanded Indications for Immunicon’s CellSearch
Immunicon’s CellSearch Circulating Tumor Cell (CTC) Kit has received FDA clearance as an aid in the monitoring of patients with metastatic prostate cancer.
The kit is now cleared for three of the four most prevalent cancers; a combined ≈$1 billion market, according to the company.
The CellSearch CTC kit was originally cleared in January 2004 to predict progression-free and overall survival in patients with metastatic breast cancer and later expanded to include monitoring. In November 2007, the kit was cleared by the FDA for monitoring metastatic colorectal cancer.
The American Cancer Society estimates that in 2006 there were 1.4 million new cancer cases diagnosed and 564,000 deaths. Close to 90% of all cancers are solid tumors or carcinomas. Computed tomography (CT) scans are standard for tracking the progression of carcinomas by assessing changes in tumor size, but CT scans are highly subjective and for
Exactech Expands Direct Distribution Abroad
Exactech, a developer of orthopedic implant devices, surgical instruments and biologic materials, announced yesterday the opening of a wholly-owned distribution subsidiary in Japan and the planned acquisition a distribution subsidiary in France.
Japan and France are two of the largest orthopedic device markets outside the U.S.
The move is part of a larger plan to aggressively grow direct sales. In early January, Exactech finalized its acquisition of North Carolina-based Altiva, an agreement that allowed the company to better leverage its sales and distribution channels in the spinal implant market.
France
France Medica SAS is an importer and distributor of orthopedic products and surgical supplies in France. The company has worked with Exactech for a number of years. In addition to distributing the Exactech’s Optetrak knee system, France Medica provides hips, shoulders, trauma products and instrumentation sets for clinics and hospitals.
France Medica’s purchase price is
New Competition for OraQuick Advance? Sublicense Agreement Expands Opportunity for Chembio’s Oral Fluid HIV Diagnostic
Chembio Diagnostics has acquired a worldwide, non-exclusive sublicense from Bio-Rad Laboratories. Under the terms of the agreement, Bio-Rad will permit Chembio to manufacture and market a rapid test for both HIV-1 and HIV-2 under Chembio brands.
Bio-Rad will retain rights to patents claiming the HIV-2 virus and various means to detect its presence in infected patients.
In June 2004, OraSure entered into a similar arrangement with Bio-Rad. OraSure’s lead product, OraQuick ADVANCE, uses oral fluids to test for HIV 1/2 and provides accurate results in 20 minutes. The test has been approved by FDA and has received support from many governmental agencies including the CDC.
Chembio Diagnostics’ Sure Check HIV and the STAT-PAK are single-use tests for the rapid, visual detection of HIV antibodies. The tests are FDA approved and CLIA waived.
Like OraQuick, these assays produce results within 20 minutes allowing testing, counseling and referrals
MedicalRecords247: A Lesson in Destructive Marketing
One of the surest and quickest ways to alienate your target audience is through the use of comment spam.
It pains me to see a new business adopt a terrible, cheap marketing strategy.
Such is the case with MedicalRecords247 – an online service that manages personal health records. Here’s one of several comments they left to piggyback off this post:
“For my money I would never trust Microsoft with this given tis track record with windows and Google has stumbled around now trying to team up with a big burecratic health system. For my money I sticking to the smaller companies like www.medicalrecords247.com to have the most relevant and easy to use system”
Given our intelligent readership – do they think paying someone to leave this type of sloppy comment spam will further their business?
Here’s another one left at IdealGovernment.com: “I trust Google but come on…this
ATS Medical’s CryoMaze: Initial Clinical Results Promising
The Cox-Maze procedure creates a series of incisions in the right and left atria of the heart to interrupt the conduction of abnormal electrical impulses which cause Atrial Fibrillation (AF). This allows sinus impulses to travel to the atrioventricular node as they normally would.
The Cox-Maze procedure has the highest success rate (≈90%) of any surgical treatment for AF. But because of its invasive open-chest nature, it is commonly performed during a concomitant procedure, most typically a mitral valve replacement or repair.
Dr. James Cox began performing the procedure at the Cleveland Clinic in 1991. As was previously announced, Cox joined ATS Medical where he is furthering the commercialization of CryoMaze, a less-invasive treatment for AF that replicates the Cox-Maze approach, making it more suitable for stand-alone procedures.
CryoMaze forgoes surgical incisions and instead freezes lines in the heart to re-direct electrical impulses. CryoMaze
Google to Tackle the Electronic Personal Health Record Industry with a Patient-Centric Focus; Monetization Opportunities Abound
The Cleveland Clinic will facilitate Google’s potential domination of the electronic personal health record (PHR) space. Google chose the Clinic because they offer 100,000 patients the tools to manage their medical records online and coordinate care with doctors using a PHR suite called eCleveland Clinic MyChart. An invitation will be extended to 1,500 - 10,000 of these users.
The trial will validate the secure exchange of patient medical record data including prescriptions, conditions and allergies between the Cleveland Clinic PHR to a secure Google profile in a live clinical delivery setting.
The goal is to give patients the ability to interact with multiple physicians, healthcare service providers and pharmacies.
“Patients are more proactively managing their own healthcare information,” said C. Martin Harris, Chief Information Officer, Cleveland Clinic. “This collaboration is intended to help Google test features and services that will ultimately allow all
U.S. Supreme Court Rules 8 to 1 in Favor of Medtronic in Riegel v. Medtronic
The decision affirmed the dismissal of the lawsuit brought by Charles Riegel, who was injured after a Medtronic balloon catheter burst during an angioplasty procedure in 1994.
Makers of medical devices are protected against liability for personal injuries provided the FDA has approved the device before it is marketed.
The Court ruled in favor of a 1976 law barring state-law claims challenging safety or effectiveness of devices that have won pre-market approval from the FDA.
The decision was seen as a victory for the Bush administration, which has fought for years to broaden the FDA’s authority over state regulation. The administration argued that there would be a serious undermining of the FDA’s authority if state-based juries could second-guess the agency.
Supreme Court Justice Antonin Scalia wrote that it would be difficult for a jury to properly assess the costs and benefits of a device, saying,
Medical Device Alternatives for Treating Depression
In the U.S., millions suffer from psychological disorders including depression, anxiety and insomnia. Doctors typically rely upon pharmaceuticals to treat the underlying symptoms. The negative side effects of these drug regimens have prompted many to look for alternative treatment methodologies.
Electronic therapeutic devices may reduce the number of drug-related errors by reducing the amount of medication needed to treat common psychological disorders.
Brainsway
Israel-based Brainsway Ltd. reported positive results this week in the testing of its non-invasive Transcranial Magnetic Stimulation (TMS) treatment for depression. So far, 64 depressive patients who did not respond to at least two antidepressant drugs have been treated with the Deep TMS device. Brainsway CEO Uzi Sofer believes the data will open the door to a CE Mark.
The company is also gearing up for a multicenter trial in the U.S. Brainsway is waiting to hear back from the FDA but
The Truth, The Whole Truth, Nothing But the Truth: No Lie MRI
“It is always the best policy to speak the truth – unless, of course, you are an exceptionally good liar,” so spoke the English author Jerome K. Jerome. This, of course, was back in the days when being an ‘exceptionally good liar’ was enough.
From individuals to corporations to governments, trust is a critical component of our ability to peacefully and meaningfully coexist with other individuals, businesses, and governments. Our society has long sought a means of detecting the truth – or more aptly, lies.
Polygraph was used extensively through the mid 1980s. The test measures whether an individual is in a state of autonomic nervous arousal, which occurs when a person is anxious, fearful, or angry. While these are potential indications that a person is not telling the truth, they are confounded with other potential explanations, including anxiousness about the testing
AdvaMed 2008 Now Accepting Panel Proposal Applications
Our friends at AdvaMed are gearing up for their annual medical technology conference and exhibition to be held September 21-24, 2008 in Washington, D.C.
In 2007, the event attracted more than 1,100 senior level executives representing some 500 companies from 35 states and 25 countries. AdvaMed members produce nearly 90% of the health care technology purchased annually in the U.S. and more than 50% purchased annually around the world.
If you’re an organization from or affiliated with the medtech industry, you can submit a proposal to organize a 90-minute panel at AdvaMed 2008.
Panel applications are reviewed by AdvaMed staff and an independent Program Committee. To download the panel proposal guidelines click here or e-mail program@advamed2008.com. AdvaMed is accepting proposals through March 21st.
The tentative program tracks are as follows:
- 21st Century Health Policy
- Business Development / Finance
- Compliance Learning & Training
- Emerging Company Issues
- Global Business Issues
- International
- Legal & Intellectual Property
- Manufacturing
- Medical
