24 Renal & Urology News JULY 2010 www.renalandurologynews.com
Industry News FDA Update and Product News
FDA Update Latest News
■ FDA Mulls Application for Prostate Imaging Device
ProUroCare Medical, Inc., of Minneapolis, Minn., has ﬁled a de novo application Over the Counter Pain
with the FDA seeking marketing clearance for its prostate mechanical imaging
(PMI) device (ProUroScan). This will allow the agency to review and potentially
classify such systems as Class II devices subject to special controls.
Relief Patches Introduced
The company’s ﬁling asks the FDA to deﬁne mechanical imaging systems as
devices intended to produce an elastic image of the prostate as an aid in docu- H isamitu Pharmaceutical, which has
U.S. headquarters in Torrance,
Calif., has introduced two over-the-
joints associated with arthritis, sprains,
strains, and simple backaches experi-
enced by patients aged 18 years and
menting abnormalities of the prostate that are initially identiﬁed by digital rectal
examination (DRE). counter pain relief patches to the older, according to the company. Each
American market, the Salonpas Pain patch contains 10% methyl salicylate
ProUroScan uses a transrectal probe with pressure sensor arrays and a
Relief Patch and Salonpas Arthritis and 3% I-menthol as the active phar-
motion tracking system. The system provides real-time elasticity images of
Pain patch. maceutical ingredients.
the prostate, the company said. The device can detect and pinpoint nodules
Both patches are formulated to pro- To introduce the patches, Hisamitsu
because they differ in hardness from surrounding healthy tissue. In a study vide temporary relief of mild to moder- says it will distribute more than two
published in Urology (2008;71:425-429), researchers showed that PMI results ate aches and pains of the muscles and million free samples.
correlated strongly with DRE ﬁndings. The investigators tested PMI and DRE
results for correlation against a transrectal ultrasound of the prostate guided
biopsy for a subgroup of 21 men with elevated PSA levels. Of 13 patients with
biopsy-conﬁrmed malignant nodules, PMI identiﬁed 10 of the nodules and DRE
Ultra-Fine Pen Needle for
identiﬁed six. PMI ﬁndings were consistent with all eight biopsy-negative cases.
DRE resulted in one false-positive result in the eight biopsy-negative cases.
Diabetes Patients Debuts
“The PMI device has the potential to document prostate nodularity by produc-
ing 3D images of the gland and its internal structures based on their respective
hardness,” the researchers concluded.
B ecton, Dickinson and Company
(BD), based in Franklin Lakes, N.J.,
has launched the BD Ultraﬁne Nano,
owner and co-founder of the Diabetes
Management and Training Centers, Inc.,