Guided Therapeutics (OTC:GTHP) said yesterday that China’s FDA has requested a small clinical trial of its LuViva line of cervical scan products. The Norcross, Ga.-based company said it received the request as a “new communication regarding regulatory approval of its LuViva line of products in China,” adding that it plans to submit final paperwork for approval […]
Canada bans Allergan Biocell breast implants
Health Canada has suspended sales of Allergan’s Biocell breast implants due to a higher incidence of a rare breast cancer in patients with macro-textured breast implants than other implants. The Allergan (NYSE: AGN) Biocell breast implants are the only macro-textured implants available in Canada. The regulatory agency instituted the ban based on the results of a 2017 safety […]
Report: J&J faces uphill battle in $20 million pelvic mesh appeal
Johnson & Johnson (NYSE:JNJ) is appealing a $20 million verdict in a 2018 Indiana pelvic mesh trial, but a federal appeals court panel pushed back against the device maker’s argument this week, according to a published report. J&J’s Ethicon subsidiary claims it was wrongly barred from presenting evidence from the FDA saying that its Prolift pelvic […]
J&J ordered to pay $80 million in Pennsylvania pelvic mesh case
A Philadelphia jury has awarded a woman $80 million for injuries caused by pelvic mesh manufactured by Johnson & Johnson’s Ethicon subsidiary, according to media reports. The award includes $50 million in punitive damages and $30 million in compensatory damages — the largest compensatory damages verdict to date in a pelvic mesh case, a company […]
FDA updates on Essure device report numbers, post-market study data
The FDA yesterday provided an update on its oversight of Bayer‘s (ETR:BAYN) Essure permanent birth control device, which was removed from the U.S. market last summer. The federal watchdog said that it received approximately 6,000 medical device reports last year, a decrease from the nearly 12,000 it received in 2017 but close to the numbers […]
AirXpanders files special FDA 510(k) seeking nod for smooth AeroForm
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 […]
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 […]
Biotronik touts launch of first NICM CRT-D, ICD treatment trial exploring sex-specific outcomes
Biotronik said today that it launched enrollment in what it claims to be the first large-scale prospective study exploring sex-specific outcomes in patients with non-ischemic cardiomyopathy treated with a cardiac defibrillator. The newly launched BIO-LIBRA study aims to enroll up to 1,000 patients, with a minimum of 40% female enrollment, and will explore whether women […]
Judge denies Minerva Surgical’s bid for new trial in $5m loss to Hologic
UPDATED May 6, 2019, with comment from Minerva. A Delaware federal judge this week denied Minerva Surgical‘s bid for a new trial in its $5 million patent infringement loss to Hologic (NSDQ:HOLX), despite an appeals court ruling last month that invalidated one of the patents at issue. Hologic’s NovaSure ablation device, acquired with the 2007 buyout […]
FDA won’t ban textured breast implants
The FDA yesterday said it won’t ban textured breast implants, which may be linked to a type of immune system cancer, after one of its advisory panels said there’s not enough evidence to support the move. In March the federal safety watchdog’s General & Plastic Surgery Devices panel held two days of hearings before reaching […]
Hologic posts Street-beating fiscal Q2 earnings
Hologic (NSDQ:HOLX) today posted fiscal year 2019 second quarter earnings that topped expectations on Wall Street and lifted its guidance for the remaining fiscal year. The Marlborough, Mass.-based company posted losses of $272.6 million, or $1.01 per share, on sales of $818.4 million for the three months ended March 30, seeing losses shrink 60% while sales […]
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