UltraShape Power Cleared for Fat Destruction

The U.S. Food and Drug Administration (FDA) has cleared Syneron Medical’s UltraShape Power for noninvasive reduction of abdominal circumference via fat cell destruction. The device uses focused, pulsed mechanical ultrasound to target and destroy fat with a proprietary pulse structure that allows for fat destruction without damaging surrounding blood vessels, nerves and muscles. UltraShape Power includes...

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UltraShape Power Cleared for Fat Destruction

The U.S. Food and Drug Administration (FDA) has cleared Syneron Medical’s UltraShape...

The American Academy of Dermatology Association (AADA) has established a Task Force on...

Biotechnology company Revance Therapeutics has announced the completion of its Type B/...

The Lydia Sarfati Post-Graduate SKIN CARE Academy in Secaucus, New Jersey, will be...

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Blogs

Adding Another Provider
By Mara Shorr and Jay A. Shorr, The Best Medical Business Solutions When it comes to growing your team or providers, we always advise practices to proceed thoughtfully and strategically. If you make a sudden decision because you’re feeling the heat, you can get burned with a new hire. Following is...
Creating Effective Newsletters
By Mara L. Shorr and Jay A. Shorr of Best Medical Business Solutions Each day, your patients’ email inboxes are flooded with e-newsletters and e-blasts craving their attention. Whether they come from daily deal sites, their favorite big box stores or their tried and true online retailers, the sheer...
UltraShape Power Cleared for Fat Destruction

The U.S. Food and Drug Administration (FDA) has cleared Syneron Medical’s UltraShape Power for noninvasive reduction of abdominal circumference via fat cell destruction. The device uses focused, pulsed mechanical ultrasound to target and destroy fat with a proprietary pulse structure that allows for fat destruction without damaging surrounding blood vessels, nerves and muscles. UltraShape Power includes a new transducer, which is lighter and delivers 20% more energy than its predecessor. In a recent clinical study, it demonstrated a 32% reduction in subcutaneous fat thickness.

“We are pleased to announce that we have received FDA clearance for UltraShape Power in the US. UltraShape Power’s strong market acceptance since its launch in the second quarter 2016 outside of the U.S. has been driven by its powerful noninvasive fat reduction capability, patient comfort and an emphasis on ease of use. We believe that this new generation of UltraShape will have a significant impact on our ability to continue building our global leadership position in the fast-growing, noninvasive fat destruction market,” said Amit Meridor, CEO of Syneron Candela.

Photo copyright Getty Images.

AADA Creates Task Force on Drug Pricing and Transparency

The American Academy of Dermatology Association (AADA) has established a Task Force on Drug Pricing and Transparency, citing the largest increase in drug prices in more than a decade. The issues they plan to address are summarized in a Journal of the American Academy of Dermatology article published online July 13.

The authors highlight:

  • Causes of dermatology drug price increases, including industry mergers, restricted supply, shadow pricing, high medical liability and formulary tiering structures that prioritize cost.
  • Potential solutions, such as the FDA’s ability to speed the approval of generics and allow foreign imports during drug shortages, in addition to legislative and regulatory actions that boost access to medication.
  • A table outlining the major points of the AADA’s Position Statement on Patient Access to Affordable Treatments, including its stance on transparency, restrictive formularies and caps on out-of-pocket costs.

The authors call on their fellow AAD members to contact their legislators to advocate on behalf of their patients’ best interests.

Revance to Commence Phase 3 Toxin Trials

Biotechnology company Revance Therapeutics has announced the completion of its Type B/pre-IND/pre-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) regarding injectable DaxibotulinumtoxinA (RT002) for glabellar lines. The company will be moving forward with an Investigational New Drug (IND) submission for a Phase 3 clinical program for RT002 in glabellar lines as well as other supportive studies required for Biologics License Application (BLA) filing.

Revance expects to initiate its Phase 3 trials before the end of 2016. The program will include two placebo-controlled pivotal studies conducted at multiple sites in the U.S. and Canada, with the primary endpoint being a composite of the proportion of subjects who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity on investigator assessment (IGS-FWS) and patient assessment (PFWS) scales, at maximum contraction (frown) at Week 4. The duration of the reduction of severity of the glabellar lines will be assessed as a secondary endpoint. The program will also include a long-term, open-label safety study. Revance plans to announce additional details on the study designs when the company begins dosing...

AAD Commends FDA for Indoor Tanning Restrictions

The American Academy of Dermatology (AAD) applauds the U.S. Food and Drug Administration (FDA) for proposing new regulations governing indoor tanning, including an age restriction for minors under the age of 18 as well as a risk-acknowledgement form that all adults must sign before using indoor tanning devices.


According to the AAD, statistics show that millions of people tan indoors annually and the risk of developing melanoma increases by 59% for individuals exposed to UV radiation from indoor tanning—the risk increases with each use. If the FDA’s proposed rule becomes final,... more »

ASDS Honored With 14 MarCom Awards

The American Society for Dermatologic Surgery (ASDS) and American Society for Dermatologic Surgery Association (ASDSA) were recognized with 14 awards—including three Platinums—in the 2015 MarCom Awards.


The MarCom Awards competition is administered and judged by the Association of Marketing and Communication Professionals, selecting winners “whose work serves as a benchmark for the industry.” The 2015 competition received about 6,500 entries representing more than a dozen countries.


The Platinum Award—MarCom’s top honor—was presented to ASDS in three categories: Currents... more »

Cellfina Available in US

Merz Aesthetics has begun commercial shipment of the Cellfina System, indicated for long-term improvement in the appearance of cellulite in the buttocks and thighs, to aesthetic practices in the U.S.


Cellfina combines proprietary technology with minimally invasive subcision to treat the primary structural cause of dimpled cellulite. Results of the procedure last at least two years—in clinical trials, patient satisfaction with their treatment results improved from 94% at one year to 96% at the two-year mark. The most common side effects reported were soreness, tenderness and bruising... more »