Royal Philips (NYSE:PHG) said yesterday it launched an all-in-one breast assessment solution designed for use with its Epiq and Affiniti ultrasound systems. The newly launched solution, which has received CE Mark approval in the European Union and FDA 510(k) clearance in the US, is intended for the assessment, monitoring and treatment of breast diseases, the Amsterdam-based […]
Boston Scientific touts 3-year Solyx stress urinary incontinence mesh trial data
Boston Scientific (NYSE:BSX) this week released three-year data from a study of its Solyx single incision sling system intended to treat stress urinary incontinence, touting that the trial met all primary and secondary endpoints. Boston Scientific said it presented the full results from the trial yesterday at the annual scientific symposium of the American Urogynecologic Society. The […]
DeviceTalks: Hologic CEO MacMillan on leading a turnaround and the importance of women’s health in medtech
Stephen MacMillan joined a struggling Hologic (NSDQ:HOLX) as CEO in December 2013, and within one day, he had already made his first major move in restructuring the company’s executive leadership team. MacMillan spoke in a keynote presentation at DeviceTalks Boston yesterday about his entry into the women’s healthcare market with Hologic, how his turn-around of the […]
Acessa Health wins FDA nod for 3rd-gen ProVu
Acessa Health said today it won FDA 510(k) clearance for its third-gen Acessa ProVu radiofrequency ablation system intended for use in treating symptomatic uterine fibroids. The Austin, Texas-based company said the newly cleared system features ultrasound visualization and a guidance mapping system, and that it is intended to provide a safe alternative to hysterectomy procedures for […]
Hologic closes $125m Focal Therapeutics buyout
Hologic (NSDQ:HOLX) said it closed the $125 million deal to acquire bioresorbable tissue marker developer Focal Therapeutics yesterday. Aliso Viejo, Calif.-based Focal Therapeutics makes the BioZorb bioresorbable, three-dimensional tissue marker for marking the tumor excision site in lumpectomies. Hologic said it plans to add the BioZorb marker to its breast health product portfolio. The Marlborough, Mass.-based company said […]
Merit Medical to acquire Cianna Medical for up to $200m
Merit Medical (NSDQ:MMSI) said yesterday that it agreed to acquire Cianna Medical and its breast cancer localization and guidance devices for up to $200 million. Aliso Viejo, Calif.-based Cianna makes the Savi Scout wire-free breast tumor localization system, designed to produce audible and visual indicators surgeons can use to tag cancerous tissue during lumpectomy and biopsy procedures. The device won […]
Hologic to buy Focal Therapeutics for $125m
Hologic (NSDQ:HOLX) said today it inked a $125 million deal to acquire bioresorbable tissue marker developer Focal Therapeutics. Aliso Viejo, Calif.-based Focal Therapeutics produces the BioZorb bioresorbable, three-dimensional tissue marker which is intended to improve lumpectomy surgeries by marking the tumor excision site for monitoring and future treatments. Hologic said that it will add the BioZorb marker […]
Alydia Health raises $10m in Series B
Alydia Health, formerly known as InPress Technologies, said today it closed a $10 million Series B financing round to help support its technology platform designed to prevent maternal morbidity and mortality caused by postpartum hemorrhage. The round was led by the Global Health Investment Fund and joined by Astia Angles and other existing investors. As […]
FDA pushes back on silicone breast implant study
The FDA last week pushed back at a large study showing an association between silicone breast implants and some rare diseases, standing by its record of warning the public about their risks – despite granting approvals to a slew of the implants in recent years. The study, published Sept. 14 in the Annals of Surgery, […]
Atlantic Therapeutics touts muscle stimulation device for urinary incontinence
Atlantic Therapeutics‘ Innovo shorts beat intravaginal probe devices at keeping women with stress urinary incontinence dry in an FDA-designed clinical trial. An externally worn electrical muscle stimulation device, Innovo demonstrated greatly reduced risk of infection and improved user tolerability over the intravaginal devices, according to research presented this week at the International Continence Society meeting in […]
FDA clears UVision360 hysteroscopy device
UVision360 said today it won FDA 510(k) clearance for its Luminelle DTx hysteroscopy system, now indicated for both hysteroscopy and cystoscopy. The Raleigh, N.C.-based company’s Luminelle DTx system is designed to allow physicians to see the internal lining of the uterus from an optimal distance to allow for the identification of suspicious tissue. The system […]
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