AirXpanders (ASX:AXP) said yesterday that it submitted a special 510(k) application with the FDA seeking approval for a smooth shell version of its AeroForm tissue expander system. The Palo Alto-based company’s AeroForm tissue expander is intended for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent […]
Cosmetic/Aesthetic
Sientra plunges on Q1 results
Sientra (NSDQ:SIEN) shares plunged today after the cosmetic device maker’s first-quarter earnings missed the mark by a mile. Losses grew 36.4% for Santa Barbara, Calif.-based Sientra, to -$26.5 million, or -91¢ per share, on sales growth of 19.6% to $17.6 million during the three months ended March 31, compared with Q1 2018. Analysts on Wall […]
FDA warns Surgisil for unapproved facial implant marketing
The FDA this week released a warning letter it sent to cosmetic device maker Surgisil over unapproved marketing of its Perma Facial Implant device. The letter follows an inspection of the company’s facilities in Plano, Texas, during which an FDA investigator determined that the company is marketing its Perma Facial Implant for indications outside of […]
Pulse Biosciences slides on FDA setback, Q1 miss
Pulse Biosciences (NSDQ:PLSE) said yesterday that the FDA asked for more data on the 510(k) application for its CellFX dermatology device and reported higher-than-expected first-quarter losses, sending its share price down. Hayward, Calif.-based Pulse is seeking an indication for treating general benign lesions including sebaceous hyperplasia and seborrheic keratosis. The company said it received a letter […]
FDA clears Tela Bio’s Restella soft tissue bioscaffolds
Tela Bio said yesterday that it won FDA 510(k) clearance for its Restella reconstructive bioscaffolds, now cleared for use in reinforcing soft tissue in patients requiring soft tissue repair or reinforcement during plastic or reconstructive procedures. The Malvern, Penn.-based company’s tech platform is based on interwoven polymer through layers of biologic tissue in a patented pattern […]
Australia’s TGA considering, but not yet implementing, textured breast implant ban
Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods. The regulatory body gave suppliers of the devices 10 working […]
Health Canada notifies Allergan on intent to suspend Biocell breast implant license
Health Canada said yesterday that it plans to suspend Allergan‘s (NYSE: AGN) licenses to sell its Biocell breast implants in the region due to a possible association with a rare immune system-cancer. The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of […]
Report: France to ban textured breast implants
France is planning to ban textured breast implants, which have been linked a rare immune-system cancer, according to a report from France24. France’s National Agency for Medicines and Health Products began informing manufacturers on April 2 of its plans to ban manufacturing, distribution, importing, exporting, promotion and wearing of textured breast implants and polyurethane breast […]
Apyx Medical withdraws Renuvion FDA 510(k) app for dermal resurfacing indication
Apyx Medical (NYSE:APYX), formerly known as Bovie Medical, said late yesterday that it has voluntarily withdrawn the FDA 510(k) clearance application for its J-Plasma/Renuvion device seeking a dermal resurfacing indication. The Clearwater, Fla.-based company submitted a new 510(k) clearance application seeking new indications for the Renuvion system in December. The application came supported by by […]
FDA Panel: Too early to pull textured breast implants over cancer risk, need more data
A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report. The recommendation comes from the first day of a two-day panel meeting […]
FDA warns J&J, Sientra over lack of post-approval silicone gel breast implant studies
The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants. The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct […]