Pulse Biosciences (NSDQ:PLSE) said today that it launched a clinical feasibility study of its Nano-Pulse Stimulation platform intended to treat cutaneous warts. The Nano-Pulse Stimulation system is a novel, non-thermal tech platform designed to deliver nanosecond duration energy pulses intended to disrupt functions of internal cell structures while maintaining outer cell membranes, the Hayward, Calif.-based company said. […]
Cosmetic/Aesthetic
SEC accuses ex-Sientra CEO Zeini of lying to investors ahead of $60m offering
The U.S. Securities & Exchange Commission today accused former Sientra (NSDQ:SIEN) CEO Hani Zeini of hiding a problem at the company to close a $61 million follow-on offering that led to the company losing more than half of its value. The breast implant maker relied on a single supplier for its silicone implants. But regulators in […]
Korea’s Hironic wins FDA nod for AFit laser acne device
Korean skin care device developer Hironic has won FDA approval for its AFit laser device intended to treat acne. The AFit device features a 1450 nm diode laser designed to penetrated into the dermal and subcutaneous layers. The system also features a bipolar radiofrequency and Cryogen cooling device, the company said. “AFit’s FDA approval has […]
FDA clears Surgical Innovation’s DuraSorb bioresorbable mesh
Medical device start-up Surgical Innovation Assets said yesterday it won FDA 510(k) clearance for its DuraSorb monofilament mesh, designed for reconstructive and cosmetic surgery. The newly cleared DuraSorb mesh is the first from a line of advanced bioresorbable technologies, the Chicago-based company said. The DuraSorb is intended to integrate into the patient’s tissue to provide […]
Syneron Candela acquires Denmark’s Ellipse
Syneron Candela said today it acquired Danish medical device firm Ellipse for an undisclosed amount. Ellipse produces Intense Pulsed Light and laser-based platforms intended for use as medical and aesthetic skin treatments, Wayland, Mass.-based Syneron Candela said. Key products from the Danish company include the Nordlys IPL multi-application, multi-tech IPL and the Nd:YAG platform designed for […]
Bovie Medical retools outlook
Bovie Medical (NYSE:BVX), fresh from the sale of its core electro-cautery business, saw its share price take a hit today after it updated its outlook for the rest of the year. Last month Bovie dealt its core business, including the Bovie brand, to Symmetry Surgical for $97 million. The all-cash sale augured a pivot for Clearwater, Fla.-based Bovie toward the cosmetic surgery […]
Longeviti’s ClearFit gives neurosurgeons a view inside the head
Longeviti Neuro Solutions has launched its novel ClearFit implant to correct and/or restore bony voids or defects of the cranium. This clear, patient-specific implant enables neurosurgeons to see neuroanatomy and critical functional components beneath the ClearFit once it is implanted. “The real advantage to this system is the ability to see what’s underneath the […]
Kleresca wins CE Mark for biophotonic dermatological system
Dermatological device developer Kleresca said yesterday it won CE Mark approval in the European Union for its biophotonic dermatological technology platform. The Kleresca biophotonic system uses fluorescent light energy to stimulate biological processes and repair mechanisms in the skin, the company said. Kleresca said that hte clearance will allow it to “consolidate its business on […]
Hologic pulls Vitalia handpieces, probes in light of FDA concerns over vaginal rejuv tech
Hologic (NSDQ:HOLX) said today that its subsidiary Cynosure is suspending marketing and distribution of its TempSure Vitalia handpieces and probes after the FDA released a warning about a lack of evidence to support certain “vaginal rejuvenation” products late last month. The Marlborough, Mass.-based company said that it takes “the FDA’s recent statements very seriously” and […]
Strat Skin Sciences wins FDA nod for Multi-Micro Dose excimer laser tip
Strata Skin Sciences (NSDQ:SSKN) said yesterday it won FDA 510(k) clearance for the Multi-Micro Dose tip designed for use with its Xtrac 308nm excimer laser. The newly cleared tip is indicated for use in conjunction with the Horsham, Penn.-based company’s Xtrac laser system to filter narrow band UVB light at delivery, intended to individualize non-blistering doses […]
Establishment Labs prices $67m IPO
Breast implant maker Establishment Labs yesterday priced its initial public offering at $18 per share, saying it expects to gross nearly $67 million not including a possible underwriters option. Alajuela, Costa Rica-based Establishment Labs originally registered the offering at $58 million, saying it plans to use the proceeds to fund a pre-market approval study of its Motiva implants. The FDA […]