(Reuters) – An influential panel of U.S. experts issued final recommendations on Monday reaffirming their controversial position that mammogram screening should start at age 50, but also said some women may benefit from screening starting at age 40. Under the U.S. Preventive Services Task Force guidelines, mammogram screening every two years for women 50 to […]
Women's Health
Astora lands FDA panel date for Topas incontinence device
The FDA today scheduled a panel date to discuss the premarket approval submission from Astora Women’s Health for its Topas incontinence device. The company and federal watchdog are slated to meet in late February to consider the company’s sling mesh device. The Topas is designed to be implanted around the puborectalis muscle for treating women […]
Sientra soars after independent panel OKs breast implants
Shares of Sientra (NSDQ:SIEN), which hit a 52-week low last year after regulators shut down production at its sole supplier, soared today after new CEO Jeffrey Nugent said independent testing found its breast implants safe for implantation. Santa Barbara, Calif.-based Sientra tapped Nugent shortly after Brazilian regulator Anvisa suspended production at Silimed, Sientra’s supplier, and the U.K.’s Medicines & Healthcare Products Regulatory […]
PA rep Fitzpatrick wants FDA to launch criminal probe into morcellator deaths
Rep. Mike Fitzpatrick (R-Pa.) wants the FDA to open a criminal investigation of several deaths associated with laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors. The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade […]
Gamma Medica, Alpha imaging ink distro deal for LumaGem breast imager
Gamma Medica and Alpha Imaging said today they inked a distribution agreement, with Alpha Imaging picking up Gamma’s LumaGem molecular breast imaging device for distribution in the Midwest and Mid-Atlantic regions. The LumaGem molecular breast imaging device is designed to improve the detection of early cancers in individuals with dense breast tissue and complex mammograms, […]
FDA slaps PMA requirement on pelvic mesh
The FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the product under its most stringent level of review. The federal safety watchdog said it re-classified the mesh from Class II to Class III and will require makers to go through […]
Seno Medical touts data from Imagio breast cancer pilot study
Seno Medical Instruments on Monday released data from the pilot study portion of its Pioneer pivotal study examining its Imagio opto-acoustic tool designed to diagnose breast cancer. The company said data from the trial showed Imagio system improved physicians’ ability to classify benign breast masses when compared to traditional ultrasounds methods. Data from the 100-patient […]
Jury adds $7 million in punitive damages to Johnson & Johnson’s $5.5m mesh loss
Johnson & Johnson (NYSE:JNJ) must pay $7 million in punitive damages on top of $5.5 million in compensatory damages it was ordered to pay yesterday in the 1st of a series of pelvic mesh lawsuits. Jurors took 2 hours of deliberation before they reached the $7 million figure, according to Law360.com. Johnson & Johnson and its Ethicon […]
Johnson & Johnson lose 1st Philly mesh case
A jury in Philadelphia ruled today that Johnson & Johnson (NYSE:JNJ) must pay $5.5 million in the 1st in a series of pelvic mesh lawsuits. The jury found J&J liable, based on the negligence of its scientists in relation to its Prolift pelvic mesh implant, citing it as the root cause of plaintiff Patricia Hammons’ […]
For AirXpanders, a switch from 510(k) to de novo was no big deal
Scott Dodson didn’t worry when the FDA requested a call. Dodson is CEO of AirXpanders, a Palo Alto, Calif.-based company that had made a 510(k) submission for its AeroForm tissue expander, a device designed for post-mastectomy breast reconstructions that uses a gradual patient-controlled release of compressed gas to expand and stretch the skin/underlying muscle before […]
Philips outsources mammogram electronics assembly to Note
Royal Philips (NYSE:PHG) inked an outsourced assembly deal with Northern European manufacturer NOTE to work with its Mammography Solutions division. The move was made as part of a re-organization of Philips operations in Solna, Sweden, according to NOTE. The outsourcing will utilize NOTE’s assembly capabilities, including complex assembly in a clean room environment. “We went […]