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 […]
Investor lodges class action suit against Boston Scientific over U.S. mesh withdrawal
A plaintiff purporting to represent Boston Scientific shareholders sued the company yesterday, alleging that it misled investors about the prospects for its pelvic mesh products ahead of an FDA order to halt all U.S. sales of the devices. Last week the FDA ordered an immediate halt to sales and distribution of Boston’s Uphold Lite and Xenform products; […]
Plaintiff wins $120m in latest pelvic mesh trial against Johnson & Johnson unit
A state court jury in Philadelphia reportedly slapped Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon with a $120 million verdict yesterday in a product liability lawsuit brought over one of its pelvic mesh products. The jury in the Pennsylvania Court of Common pleas awarded Susan McFarland $20 million in compensatory damages and $100 million in punitive damages after […]
Johnson & Johnson settles Washington AG’s pelvic mesh suit for $10m
Johnson & Johnson (NYSE:JNJ) has agreed to pay $9.9 million to settle a suit it faced from Washington Attorney General Bob Ferguson over a failure to include serious risks in instructions and marketing materials for surgical mesh devices, according to a Washington State Office of the Attorney General release. Approximately 14,000 women in Washington State have […]
Appeals court hands Hologic a loss in patent spat with Minerva Surgical
The U.S. Court of Appeals for the Federal Circuit today ruled against Hologic (NSDQ:HOLX) in a patent spat with Minerva Surgical, upholding a ruling from the U.S. Patent Trial and Appeal Board that claims on a patent Hologic owns, related to detecting perforations in body cavities during ablation, are unpatentable as obvious. In the case, Minerva […]
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