Syneron Candela said today it won FDA clearance for a next-gen version of its Vbeam, the Vbeam Prima cosmetic laser designed to treat skin conditions. The newly cleared device is intended for use in treating skin conditions including rosacea, port wine stains, acne, facial, leg and spider veins, scars, benign pigmented lesions and wrinkles, warts, […]
Cosmetic/Aesthetic
Skin treatment device-maker Clarify Medical raises $1m
Clarify Medical has raised $1 million from 7 investors as part of a $1.5 million offering, according to a document filed with the SEC this week. The San Diego, California-based company has not publicly clarified how it plans to spend its new funds. Clarify Medical sells an at-home light therapy device designed for people living […]
Breast implant maker Establishment Labs registers for $58m IPO
Breast implant maker Establishment Labs yesterday registered for an initial public offering worth nearly $58 million, saying it plans to use the proceeds to fund a pre-market approval study of its Motiva implants. The FDA granted an investigational device exemption in March for the PMA study and enrolled the first patient the next month, the […]
Viveve settles IP suit against Thermigen
Viveve (NSDQ:VIVE) said this week it inked a settlement and licensing agreement with Thermigen and associated defendants to resolve a patent litigation claiming Thermigen improperly used Viveve intellectual property with its ThermiVa system. The resolution clears up all pending disputes between the companies, according to an SEC filing from Englewood, Colo.-based Viveve, and grants Thermigen a non-exclusive, […]
Bovie Medical shares rise on Q1 sales Beat, closed enrollment of cosmetic J-Plasma IDE study
Shares in Bovie Medical (NYSE:BVX) rose today after the medical device maker beat sales expectations on Wall Street with its first quarter earnings release and announced that it closed enrollment of an FDA investigational device exemption study of its J-Plasma tech seeking a new cosmetic indication. The Clearwater, Fla.-based company posted losses of $935,000, or 3¢ […]
FDA OKs Opus breast implant line from Sientra
The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants. The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016. Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when […]
Bovie Medical launches Renuvion cosmetic surgery J-Plasma brand
Bovie Medical (NYSE:BVX) said yesterday it launched the Renuvion brand of cosmetic surgery devices using its J-Plasma technology. Through the newly launched brand, the Clearwater, Fla.-based company said it will sell devices powered by the J-Plasma technology specifically for the cosmetic surgery market. The J-Plasma device is a plasma-based cutter and coagulator that uses helium ionization […]
Bovie Medical launches IDE J-Plasma dermal skin resurfacing study
Bovie Medical (NYSE:BVX) said today it launched an FDA investigational device exemption clinical study of its J-Plasma surgical cutter, looking to explore the use of the device in dermal skin resurfacing. The first patient in the trial was enrolled by Dr. J. Holcomb at Sarasota, Fla.’s Institute for Integrated Aesthetics. The J-Plasma device is a plasma-based cutter […]
7 medtech stories we missed this week: Oct. 13, 2017
From Orthocell’s distribution deal to CorNeat unveiling its artificial cornea, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. OrthoCell inks Australian distro deal Orthocell announced in an Oct. 10 press release that it has signed a distribution deal with Surgical Specialities. The deal will make Surgical Specialities the […]
These 7 antique medical devices will make you shudder
It’s a good thing we live in the times of modern medicine. Historically, medical devices have been scary and unorthodox – and sometimes amounted to downright quackery. Surprisingly, a lot of these devices were thought to be useful in their era, long before the U.S. FDA started preapproving devices (which wasn’t until the 1970s). You […]
Robotic hair transplant dev Restoration Robotics raises $25m in IPO
Robotic hair restoration company Restoration Robotics has raised $25 million in an initial public offering and seen its shares rise nearly 40% after its debut, according to a Silicone Valley Business Journal report. The 91-person company, co-founded by surgical robotics pioneer Fred Moll, sold 3.6 million shares at $7 each, then proceeded to open at […]