Hologic (NSDQ:HOLX) announced that it acquired fibroid treatment developer Acessa Health in a deal worth approximately $80 million. Austin, Texas-based Acessa markets the Acessa ProVu fully integrated laparoscopic system for combining radiofrequency ablation with intra-abdominal ultrasound visualization and guidance mapping for treating women with symptomatic, benign uterine fibroids. Marlborough, Mass.-based Hologic said in a news release […]
FDA clears Pelvital pelvic floor device
Pelvital announced that it received FDA clearance for its Flyte device for treating those with stress urinary incontinence. Minneapolis-based Pelvital touts Flyte as a first-of-its-kind, non-invasive, intravaginal home-use device designed to strengthen the pelvic floor muscles, which can help women with stress urinary incontinence, according to a news release. Physicians at the Arctic University of […]
BREAKING: Bayer settles 90% of Essure claims for $1.6B
Bayer (ETR:BAYN) announced today that settled approximately 90% of U.S. claims involving women alleging injuries related to its Essure device. Leverkusen, Germany-based Bayer reached agreements with plaintiff law firms on about 90% of the nearly 39,000 filed and unfiled U.S. Essure claims from women who allege device-related injuries, according to a news release. Settlements include all […]
Bayer sets aside nearly $1.4B for potential Essure settlements
Bayer (ETR:BAYN) during its second quarter ended June 30 set aside €1.245 billion ($1.39 billion), mainly to provide for potential lawsuit settlements related to its Essure permanent birth control device. Some of the provision was also for litigation defense costs and other pharmaceutical matters. As of July 24, Bayer faced U.S. lawsuits from roughly 32,000 Essure […]
FDA approves new Medtronic neurostim leads
Medtronic (NYSE:MDT) announced today that it received FDA approval for its InterStim Micro neurostimulator and SureScan MRI leads. Fridley, Minn.-based Medtronic’s InterStim Micro device for delivering sacral neuromodulation (SNM) therapy is used in treating overactive bladder, fecal incontinence and non-obstructive urinary retention. According to a news release, it is the smallest rechargeable device of its kind. […]
Hologic blasts American Cancer Society over new Pap test guidelines
Hologic (NSDQ:HOLX) — a major company in the Pap and human papillomavirus (HPV) testing space — is criticizing the American Cancer Society over new cervical cancer screening recommendations that prefer simply doing HPV tests every five years. “Although all the screening tests are good at finding cancer and pre-cancer, primary HPV testing is better at finding […]
FDA approves Channel Medsystems’ cryotherapy device
Channel Medsystems announced today that it received FDA approval for its next-generation Cerene cryotherapy device for treating menstrual bleeding. Cerene initially received FDA premarket approval in March 2019 as a device with proprietary, hand-held technology for delivering cryotherapy to the lining of the uterus, freezing the tissue and significantly reducing future menstrual bleeding. The device […]
Bayer failed to report Essure problems, lawsuit claims
Bayer (ETR:BAYN) failed to tell FDA about thousands of injury complaints related to its Essure contraceptive device, according to newly unsealed lawsuit documents reported by Bloomberg. The lawsuit documents out of California claim that the underreporting went back before Bayer acquired Essure maker Conceptus for $1.1 billion in 2013. Bayer responded to Bloomberg last week that […]
Essure study shows more pain, bleeding in women with implant
Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control. The FDA posted the results as part of a long-term safety evaluation of the device, which has […]
AdaptHealth prices $124m upsized offering
AdaptHealth (NSDQ:AHCO) announced today that it upsized and priced an underwritten offering of common stock at approximately $124 million. Plymouth Meeting, Pa.-based AdaptHealth is offering 8 million shares of its Class A common stock at $15.50 per share. The maker of home medical equipment, supplies and related services had previously set the offering at 6.5 […]
Gynesonics lands FDA clearance for fibroid-removal system
Gynesonics announced that it received FDA 510(k) clearance for its next-generation Sonata System 2.1 for transcervical fibroid ablation (TFA). Redwood City, Calif.-based Gynesonics’ Sonata platform integrates what the company touts as the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device. The system provides an incision-free, uterus-preserving transcervical treatment for symptomatic […]
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