|Name/Company||Approval Dates and Comments|
Taliglucerase alfa for injection
The US FDA approved this enzyme replacement therapy in May 2012 for the long-term treatment of adults with a confirmed diagnosis of Type 1 (non-neuropathic) Gaucher disease. It is the first approved plant cell-expressed drug that is derived from a proprietary manufacturing system (ProCellEx®, Protalix BioTherapeutics), using genetically engineered carrot cells. Treatment is administered every other week by a health care professional.
Nd:YAG surgical laser
Fotona® XP Laser
US FDA 510(k) clearance was granted to this Nd:YAG laser device in March 2012. Intended uses include: matrixectomy, radical nail excision, periungual and subungual warts, plantar warts, neuromas, and temporary increase of clear nail in patients with onychomycosis.
Q-switched laser for melasma
This Q-switched laser device received FDA clearance in March 2012 for the treatment of melasma. A controlled split face study of this 1064 nm Q-switched laser, at low fluence and short pulse widths, demonstrated statistically significant reductions in the appearance of melasma.
Diode hair removal laser
The FDA granted regulatory clearance in April 2012 to market this hair removal laser. The manufacturer’s press release describes the unit as providing optimal efficacy by utilizing a larger spot size, which reduces treatment time and penetrates deeply to maximize hair removal outcomes.
Low-level laser diode device for circumferential reduction
FDA clearance was granted to this novel direct skin contact laser device in April 2012 for fat reduction and body contouring. According to the manufacturer, the unit emits low levels of laser energy, generating chemical signaling in fat cells and breaking down stored triglycerides into free fatty acids and glycerol, which are released though channels in cell membranes. The fatty acids and glycerol are transported to body tissues for use during metabolism to yield energy. In conjunction, a period of post-treatment exercise facilitates metabolism and elimination of the released fatty acids from the body.
FDA device clearance was granted to this diode laser in April 2012. The laser system is generally indicated for use in incision, excision, vaporization, abalation, hemostasis, or coagulation of soft tissue.
In March 2012, the FDA issued a safety notice to healthcare professionals and cautioned consumers to avoid the use of skin creams, beauty and antiseptic soaps, or lotions that may contain mercury, a potent toxin that can cause neurological symptoms, kidney damage, and birth defects. Over the last few years, more than 35 products containing unacceptable levels of mercury have been uncovered by the agency. The products are illegally imported and sold in the US, or brought into the country for personal use. They are marketed as skin lighteners and anti-aging treatments to remove age spots, freckles, blemishes, and wrinkles, or as acne treatments. Consumers are urged to check product labels or listed ingredients for any mention of mercurous chloride, calomel, mercuric, mercurio, or mercury, and discontinue use immediately if found.