Hologic (NSDQ:HOLX) announced that it won an extension of the CE Mark approval for its LOCalizer radiofrequency identification (RFID) tag for long-term placement. Under yesterday’s extension approval, the LOCalizer can now be implanted more than 30 days prior to a breast-conserving surgery to improve flexibility and convenience for both patients and providers. The LOCalizer is a […]
Renovia lands FDA clearance for updated pelvic device
Renovia announced today that it won FDA 510(k) clearance for its next-generation Leva pelvic digital therapeutic for urinary incontinence (UI) in women. The Leva system is designed to strengthen pelvic floor muscles and treat stress incontinence as well as mixed and mild-to-moderate urgency UI in women. It uses Renovia’s patented movement-based sensor and app technology […]
Hologic to sell Cynosure medical aesthetics business for $205m
Hologic (NSDQ:HOLX) announced today that it entered into a definitive agreement to sell its Cynosure medical aesthetics business in a deal worth more than $200 million. The Marlborough, Mass.–based company is in agreement with an affiliate of investment funds managed by Clayton, Dubilier & Rice and expected to collect net cash proceeds of approximately $138 million, according […]
Gynesonics launches Sonata 2 System
Gynesonics has announced the full U.S. and European launch of its Sonata 2 transcervical fibroid ablation system for incisionless, uterus-preserving procedures. The Sonata 2 system is the world’s first and only transcervical fibroid ablation system to combine intrauterine ultrasound guidance with targeted radiofrequency energy in the incisionless procedure, according to a Nov. 11 news release. […]
Invo Bioscience signs European distribution deal
Invo Bioscience (OTCQB:IVOB) announced that it entered into commercialization agreements covering Turkey and Jordan to support the company’s expansion into Eurasia. The commercialization agreements are in place to spread the Lakewood Ranch, Fla.–based company’s InvoCell in vivo fertility system to the Eurasia area. Invo Bioscience said research shows that an estimated 15% to 20% of the […]
Hologic wins FDA approval for 3DQuorum AI imaging technology
Hologic today said it received FDA approval for its 3DQuorum Imaging Technology that is powered by the company’s Genius AI. The imaging technology works with Hologic’s Clarity HD high-resolution imaging technology to reduce tomosynthesis image volume for radiologists. Using Genius AI-powered analytics, 3DQuorum reconstructs high-resolution 3D data to make 6mm “SmartSlices.” The analytics help doctors […]
FDA panel wants info on metal implant reactions
This article has been updated with a link to the FDA webcasts of the proceedings. An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device. The Immunology Devices Panel of the agency’s Center for Devices and Radiological […]
Sientra posts Q3 losses, acquires Opus breast implant operation
Sientra (NSDQ:SIEN) shares skyrocketed today after the company posted Street-beating third-quarter results despite a bottom-line dip. The Santa Barbara, Calif.-based company is also acquiring the Opus breast implant manufacturing operation. Sientra posted losses of -$22.43 million, or -45¢ per share, on sales of $22.41 for the three months ended Sept. 30, for a 9.2% bottom-line slide […]
Hologic Q4 results meet or beat The Street
Hologic (NSDQ:HOLX) stock is up in after-hours trading this evening after the company posted fourth-quarter results that met or beat analysts’ expectations. The Marlborough, Mass.–based women’s health medtech company reported profits of $39.9 million, or 15¢ per share, on sales of $865.8 million for the three months ended Sept. 28, 2019, versus $50.5 million, or 18¢ […]
Hologic launches Definity cervical dilator
Hologic (NSDQ:HOLX) said it has launched its Definity cervical dilator for accessing uterine cavities without a tenaculum. The device uses SureAccess balloon technology to access the cavities to lessen patient discomfort and reduce the risk of perforation during dilation, was soon to hit the market, according to the Marlborough, Mass.-based company. The Definity dilator is […]
Invo Bioscience wins CE Mark for InvoCell fertility device
INVO Bioscience (OTCQB:IVOB) said last week that it received CE Mark approval for its InvoCell culture and retention device as an alternative to traditional in vitro fertilization treatment. InvoCell won FDA de novo approval in November 2015 and was launched in the U.S. in April 2016. Currently, it is distributed throughout the U.S. under an $8 […]
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