The FDA announced today that it authorized marketing for Memic Innovative Surgery’s Hominis system for transvaginal hysterectomy. Hominis is the first FDA-approved robotically-assisted surgical device for performing transvaginal hysterectomy, with indication for performing benign hysterectomy with salpingo-oophorectomy, according to an FDA news release. Using minimally invasive surgical instruments inserted through the vagina and a video […]
Women's Health
Axonics acquires Contura and its Bulkamid bulking agent for $235M
Axonics (NSDQ: AXNX) announced today that it acquired Contura and its flagship Bulkamid product for up to $235 million. London-based Contura’s Bulkamid is a urethral bulking agent for women with stress urinary incontinence (SUI). It is a next-generation hydrogel injected into the urethral wall in a minimally invasive office or outpatient facility procedure to restore the natural […]
UK passes post-Brexit medical device regulation
The U.K. has enacted a new law governing medical devices and drugs, with a focus on patient safety. The Medicines and Medical Devices Act, introduced in July 2020, establishes the position of commissioner for patient safety to respond to public and patient complaints and concerns about drugs and medical devices. The law was necessitated by […]
Hologic completes Biotheranostics acquisition
Hologic (NSDQ:HOLX) announced that it completed its previously announced acquisition of Biotheranostics for $230 million. Marlborough, Mass.-based Hologic last month announced that it was set to buy Biotheranostics and its two molecular diagnostic tests for breast and metastatic cancers, the Breast Cancer Index and CancerTYPE ID. Both laboratory-developed tests are not required to be cleared by […]
Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women. The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine […]
FDA approves expanded labeling for Medtronic InterStim SureScan MRI leads
Medtronic (NYSE:MDT) announced today that it received FDA approval for expanded MRI labeling of its InterStim SNM systems. Fridley, Minn.-based Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads were approved under updated MRI guidelines allowing for a wider range of MRI scan parameters and shorter wait times between scans, […]
Federal lawsuit over Boston Sci pelvic mesh heads to trial
A federal judge in Arkansas has ruled that most counts in a pelvic mesh lawsuit against Boston Scientific can go to trial. Kortney Cline sued Boston Sci in 2014, claiming that she suffered injuries after implantation with the company’s Obtryx trans-obturator mid-urethral sling in 2009. Cline’s case was recently transferred to federal court in Arkansas […]
GE Healthcare sells molecular breast imaging assets to SmartBreast
SmartBreast today announced that it has acquired GE Healthcare (NYSE:GE)’s molecular breast imaging assets for an undisclosed amount. The Pittsburgh-based company acquired the Discovery NM750b and other MBI scanner designs, manufacturing tools, instructions and related patents and installed-base service business as part of the deal. SmartBreast will begin to market and distribute the Discovery NM750b and […]
CooperSurgical acquires Aegea Medical and its water vapor ablation system
CooperCompanies’ (NYSE:COO) CooperSurgical business has purchased Aegea Medical, nearly a year after Aegea secured FDA approval for its Mara water vapor ablation system for treating heavy menstrual bleeding. The financial terms of the deal were not disclosed in the companies’ announcement yesterday. The companies pointed out an international, multi-center pivotal clinical trial enrolling 155 women, […]
Hologic and Google Cloud team up on digital diagnostics for cervical cancer
Hologic (NSDQ:HOLX) has entered into a multi-year deal to use Google Cloud’s machine learning and deep learning technologies with its Genius digital diagnostics system, a cytology platform that uses volumetric imaging data to identify precancerous lesions and cancer cells of the cervix. The machine learning and deep learning capabilities from Google Cloud will enable Hologic […]
COVID-19 assays sales power Hologic to Street-beating Q1
Hologic (NSDQ:HOLX) shares ticked up after hours today on first-quarter results that topped the consensus forecast. The Marlborough, Mass.-based company posted profits of $653.4 million, or $2.50 per share, on sales of $1.6 billion for the three months ended Dec. 26, 2020, for a 69.4% bottom-line gain on sales growth of 89.3%. Adjusted to exclude one-time […]
