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Mapping Malignancies
Medical Tactile, Inc’s, visual
mapping system that electronically
documents clinical breast
exams (SureTouch) has received
approval from the US Food and
Drug Administration (FDA) to
commence with commercial
sales. Through a hand-held
probe, the product palpates suspicious
breast lesions as small as
5 mm; an electronic record is
then created. Recently displayed
at the San Antonio Breast
Cancer Symposium (December
2005), the system is designed to
improve the sensitivity, specificity,
and objectivity of manual
breast palpation exams.
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Better Than a Bone Scan
Roche Diagnostics’ blood test
measuring the concentration of
osteocalcin in blood serum
(Elecsys N-MID Osteocalcin)
has been approved for use in
the treatment of postmenopausal
osteoporosis. The test would
enable physicians to track
patients’ progress by showing any
indications of bone formation.
It would also encourage regular
monitoring of osteoporosis, as
it can be performed more frequently
than the bone scan.
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Antidepressant to
Treat Panic
Wyeth Pharmaceuticals’ venlafaxine/
hydrochloric acid in capsule
form (Effexor XR), a serotoninnorepinephrine
reuptake inhibitor,
has received clearance by
the FDA for the treatment of
panic disorder in adults. The
final authorization, which marks
the first antidepressant to be
approved for panic disorder in
almost 4 years, was based on the
product’s efficacy in two doubleblind,
12-week placebo-controlled
studies, and one 26-week trial.
The product is already marketable
as a therapy for major
depressive disorder, generalized
anxiety disorder, and social
anxiety disorder.
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Freezing Fibroadenoma
Galil Medical’s minimally invasive
cryotherapy technology
(CryoHit) received FDA clearance
for the treatment of breast
fibroadenoma. With ultrasound
guidance, the product ablates
benign tumors at sub-zero
temperatures through the insertion
of 1.47-mm needles. The
technology would allow patients
to have benign tumors removed
at the clinic or on an outpatient
basis, with a short recovery time
and no surgical scarring. The
technology has been FDAapproved
since 1998 for a
variety of other indications
including prostate, kidney,
and liver cancers.
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Mammogram Flexibility
R2 Technology, Inc, has
recently introduced their new
mammography computer-aided
detection (CAD) system
(Imagechecker, Version 8.1)
into the health care market. It
is the first CAD system to offer
separate operating points
between highest sensitivity and
lowest false-marker rates. The
product’s updated features
enable radiologists to indicate a
mass with microcalcifications,
determine lesion significance,
process mammography quickly,
and scan film from a distance.
Clinical studies have previously
shown that use of the CAD system
results in 6.6% to 19.5%
more cancers detected.
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