Cutera (Nasdaq:CUTR) announced today that it received FDA 510(k) clearance for its AviClear acne treatment device. Brisbane, California-based Cutera designed AviClear as a laser treatment for the safe, prescription-free reduction of existing acne. The company said breakout episodes are shorter, less intense and more infrequent following use. Cutera said AviClear is the only energy-based device […]
Cosmetic/Aesthetic
Sientra breast implants win regulatory nod in Canada
Sientra today announced that it received approval from Health Canada to market its smooth surface, high-strength cohesive silicone gel breast implants. The Santa Barbara, California-based company will market the breast implants in Canada through its local partner Kai Aesthetic. Through the distribution agreement, Sientra will uphold the highest product, safety and service standards to patients […]
FDA accepts label update for Suneva’s handheld plasma energy device
Suneva Medical announced today that the FDA accepted updates to its Plasma IQ handheld plasma energy device. The news comes as Suneva prepares to go public through a special purpose acquisition company (SPAC) deal. San Diego-based Suneva Medical designed the Plasma IQ to remove and destroy skin lesions and coagulation of tissue. The company touts […]
Strata Skin Sciences signs distribution deal in Israel
Strata Skin Sciences this week announced that it signed a distribution agreement with JuvenIL to supply Strata’s Xtrac excimer lasers in Israel. Israel-based JuvenIL makes dermatology and aesthetic technologies for medical centers across the country. The distribution deal will provide Strata Skin Sciences with a similar distribution network. “We believe that entering into the Israeli […]
Strata Skin Sciences to acquire acne treatment assets from Theravant
Strata Skin Sciences this week announced that it has acquired Theravant’s TheraClear acne treatment system for $1 million. Horsham, Pennsylvania-based Strata Skin Sciences makes products to treat dermatologic conditions, and the acquisition expands its offerings to the acne treatment market. “As we sought to expand and capitalize on our opportunities for medical device treatment of […]
FDA approves injectable atopic dermatitis treatment from LEO Pharma
LEO Pharma announced today that it received FDA approval for its Adbry injection treatment for moderate-to-severe atopic dermatitis. Ballerup, Denmark-based LEO Pharma designed its Adbry injection for treating atopic dermatitis in adults aged 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Get the […]
NovaBay prices $15M private placement
NovaBay Pharmaceuticals (NYSE:NBY) announced today that it entered into a securities purchase agreement with proceeds of approximately $15 million. Emeryville, California-based NovaBay’s agreement with certain institutional investors occurred in connection with a private placement of 15,000 shares of a newly created Series B non-voting convertible preferred stock. Get the full story at our sister site, […]
Strata Skin Sciences buys Ra Medical’s Pharos dermatology business
Strata Skin Sciences (NSDQ:SSKN) announced that it acquired the Pharos dermatology business from Ra Medical (NYSE:RMED). Horsham, Pa.-based Strata can now market its full business solution to Ra Medical’s existing customer base comprised of 400 dermatology practices, offering opportunities to increase its recurring revenue base and a pathway to gain additional placements for its XTRAC […]
Sientra misses Wall Street estimates in Q2
Sientra (NSDQ:SIEN) posted second-quarter results this week that missed the earnings and revenue estimates on Wall Street. The Santa Barbara, Calif.-based medical aesthetics company reported losses of -$20.1 million, or -35¢ per share, on sales of $20.1 million for the three months ended June 30 for a sales growth of 115.95% compared with Q2 2020. Sientra’s […]
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
Sientra names VP of R&D
Sientra (NSDQ:SIEN) today said it appointed Denise Dajles as VP of research and development, effective June 2. Dajles will lead the Santa Barbara, Calif.-based company’s R&D and medical affairs teams and will report to CEO Ron Menezes. “We are pleased to welcome Denise to the Sientra management team,” Menezes said in a news release. “With her […]