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 […]
Allergan, Ideal Implant targets of FDA warning letters
The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements. One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of […]
Minerva Surgical closes on Boston Sci intrauterine health franchise buy
Minerva Surgical today said it closed the acquisition of Boston Scientific’s intrauterine health franchise. The financial details of the deal were not disclosed. The new combination of devices includes the Minerva Endometrial Ablation System and the Genesys HTA Endometrial Ablation System for visualization in the uterine cavity during treatment. The deal also includes the Symphion […]
Viveve Medical raises $3.2m
Viveve Medical (NSDQ:VIVE) filed an SEC Form D yesterday to confirm the sale of more than $3.2 million in options, warrants and other rights to acquire other securities. The company made the first sale in the offering on April 20 and has now sold the total offering amount of $3,225,875. There is a sales commission worth […]
Cutera, Senseonics and more receive Paycheck Protection Program loans
A number of medtech companies announced that they received millions of dollars in loans through the Paycheck Protection Program of the Coronavirus Aid, Relief and Economic Security (CARES) Act. Cutera (NSDQ:CUTR), Senseonics (NYSE:SENS), Viveve Medical (NSDQ:VIVE) and Encision (ECIA:ECIA) received approximately $15 million combined through the program administered by the U.S. Small Business Administration amid the COVID-19 pandemic. […]
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