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Women's Health

Bayer sets aside nearly $1.4B for potential Essure settlements

August 4, 2020 By Chris Newmarker

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 […]

Filed Under: Featured, Gynecological, Legal News, Product Liability, Regulatory/Compliance, Women's Health Tagged With: Bayer, Essure

FDA approves new Medtronic neurostim leads

August 3, 2020 By Sean Whooley

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. […]

Filed Under: Featured, Food & Drug Administration (FDA), Gynecological, Men's Health, Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance, Urology, Women's Health Tagged With: FDA, Medtronic

Hologic blasts American Cancer Society over new Pap test guidelines

August 3, 2020 By Chris Newmarker

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 […]

Filed Under: Diagnostics, Featured, Gynecological, News Well, Oncology, Women's Health Tagged With: American Cancer Society, cervical cancer, Hologic

FDA approves Channel Medsystems’ cryotherapy device

July 21, 2020 By Sean Whooley

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 […]

Filed Under: Food & Drug Administration (FDA), Gynecological, Regulatory/Compliance, Women's Health Tagged With: Channel Medsystems, FDA

Bayer failed to report Essure problems, lawsuit claims

July 13, 2020 By Chris Newmarker

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Gynecological, Legal News, Product Liability, Regulatory/Compliance, Women's Health Tagged With: Bayer, Essure

Essure study shows more pain, bleeding in women with implant

July 8, 2020 By Sean Whooley

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Gynecological, Recalls, Regulatory/Compliance, Women's Health Tagged With: Bayer, Essure, FDA

AdaptHealth prices $124m upsized offering

July 1, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diabetes, Funding Roundup, Gynecological, Men's Health, Respiratory, Urology, Wall Street Beat, Women's Health, Wound Care Tagged With: AdaptHealth

Acessa Health appoints three new executives to leadership team

June 18, 2020 By Danielle Kirsh

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 […]

Filed Under: Business/Financial News, Women's Health Tagged With: acessahealth

Philips launches remote fetal monitor for high-risk pregnancies during COVID-19

June 12, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Patient Monitoring, Women's Health Tagged With: coronavirus, COVID-19, Philips

Gynesonics lands FDA clearance for fibroid-removal system

May 29, 2020 By Sean Whooley

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 […]

Filed Under: 510(k), Business/Financial News, Food & Drug Administration (FDA), Gynecological, Regulatory/Compliance, Women's Health Tagged With: FDA, Gynesonics

Invo Bioscience raises $2.1m

May 29, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Funding Roundup, Gynecological, Women's Health Tagged With: INVO Bioscience

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