Hologic (NSDQ:HOLX) announced that it agreed to acquire molecular diagnostic test maker Biotheranostics for approximately $230 million. Privately held, commercial-stage Biotheranostics provides molecular diagnostics for breast and metastatic cancers. Both of its tests are PCR-based gene expression tests which have been validated in large studies in areas of oncology with unmet needs and high growth potential, […]
Women's Health
Hologic to buy Somatex and its biopsy site marker tech for $64M
Hologic (NSDQ:HOLX) announced today that it completed the acquisition of Somatex Medical Technologies GmbH for $64 million. Marlborough, Mass.-based Hologic’s acquisition of the company, which was previously owned by E-Med Solutions GmbH, is slated to support its strategy of providing further solutions across the continuum of breast health care and across Europe, according to a news […]
FDA updates power morcellator warnings for fibroid procedures
The FDA today recommended that manufacturers of laparoscopic power morcellators, which have been implicated in the spread of cancer, add noticeable and easy-to-read boxed warnings about the risks in using the devices in gynecologic procedures. In its final guidance on the topic, the agency recommends that laparoscopic power morcellation (LPM) be limited to use with certain tissue containment […]
IBS treatment gains FDA De Novo clearance
The FDA has granted De Novo clearance to a prescription treatment for irritable bowel syndrome (IBS) from Mahana Therapeutics. San Francisco-based Mahana Therapeutics’ Parallel uses cognitive-behavioral theory (CBT) to influence the communication between the brain and the gut to improve IBS, according to the company’s website. The device classification section of the FDA’s website confirms […]
Ex-Sanovas CEO sentenced to 11+ years in fraud case
Former Sanovas president & CEO Larry Gerrans was sentenced yesterday to 135 months in prison for wire fraud and money laundering in connection with a scheme to defraud the medical device company. U.S. District Judge Edward M. Chen handed down the sentence following a guilty verdict after a two-week trial in San Francisco in January 2020. The […]
Hologic launches hysteroscopy system
Hologic (NSDQ:HOLX) announced today that it launched the Omni suite for optimizing diagnostic and operative hysteroscopy. Marlborough, Mass.-based Hologic’s newly launched suite includes the Omni 30° hysteroscope along with Omni 4K video technology to complement its existing portfolio of GYN surgical solutions, according to a news release. The new Omni hysteroscope offers diagnostic and operative versatility […]
Medtronic issues safety notice for InterStim SureScan MRI leads
Medtronic (NYSE:MDT) recently issued an urgent field safety notice to alert users to a potential issue with its InterStim SureScan MRI leads. Fridley, Minn.-based Medtronic said in the notice out of Germany that the Medtronic Model 3560030/3560022 percutaneous extension is intended for use with the Model 978A1/978B1 InterStim SureScan MRI leads during an advanced evaluation to […]
Axonics launches SNS postmarket study
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it is launching a post-market clinical registry study for its r-SNM system. Irvine, Calif.-based Axonics’ implantable sacral neuromodulation (SNM) system is designed for treating urinary and bowel dysfunction with a battery life of 15 years or more. The Axonics Sacral Neuromodulation System Registry (Artistry) study is a prospective, multicenter […]
GE Healthcare debuts breast cancer tech
GE Healthcare (NYSE:GE) announced today that it made the Serena Bright biopsy technology available in the U.S. Chicago-based GE Healthcare touts Serena Bright as the industry’s first contrast-enhanced guided biopsy solution, according to a news release. The technology is designed to help clinicians and patients in the fight against breast cancer. Serena Bright received FDA 510(k) […]
Bard prevails in pelvic mesh trial
The Supreme Court of Missouri ruled in favor of Becton Dickinson’s (NYSE:BDX) C.R. Bard business in a lawsuit alleging liability issues with its pelvic mesh. In 2013, Eve Sherrer filed claims over polypropylene mesh slings that she’d had implanted in 2011 and 2012 to treat urinary incontinence, including claims for negligence, design and manufacturing defects, and […]
First patient implanted with Medtronic InterStim Micro
Medtronic (NYSE:MDT) announced today that the first patient was implanted in the study of its InterStim Micro SNS system. Fridley, Minn.-based Medtronic’s Elite study of the rechargeable InterStim Micro SNS (sacral neurostimulation) system includes all SNS indications for symptoms of overactive bladder, including urinary urge incontinence (UUI) and urinary frequency (UF), along with non-obstructive urinary retention […]
