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 […]
Women's Health
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 […]
Acessa Health appoints three new executives to leadership team
Acessa Health this week announced it added three new executives to its team. Shonu Gandhi was appointed VP of market access and clinical strategy. Her role will be focusing on improving patient access to the Acessa procedure by expanding payer coverage and clinical evidence. Gandhi has more than 10 years of experience and most recently […]
Philips launches remote fetal monitor for high-risk pregnancies during COVID-19
Royal Philips (NYSE:PHG) announced today that it launched an addition to its remote patient monitoring platform for at-risk populations during the COVID-19 pandemic. Amsterdam-based Philips added the Avalon CL fetal and maternal pod and patch for reducing unnecessary physical interactions between clinicians and patients to prevent transmission of the coronavirus. The patch makes up part of […]
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 […]
Invo Bioscience raises $2.1m
Invo Bioscience (OTCQB:IVOB) filed an SEC Form D to confirm the sale of more than $2.1 million in equity, debt and other warrants and options. The Sarasota, Fla.-based company made its first sale in the new notice on May 15, collecting the more than $2.1 million from eight investors so far. The offering is not being […]