UroMems announced today that it added $8.3 million to its Series B financing round, bringing the total funds raised to $27.3 million. Grenoble, France-based UroMems’ $27.3 million (€23 million) financing round had its first tranche completed in May 2020 but added the $8.3 million (€7 million) thanks to existing investors including Hil-Invent GmbH, Financière Arbevel, […]
Urology
FDA clears point-of-care STI test
The FDA announced today that it authorized the Binx Health IO CT/NG assay at point-of-care settings to diagnose STIs. Point-of-care settings include physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance or certificate of accreditation, according to a news […]
Boston Scientific to acquire Lumenis surgical business for $1.07B
Boston Scientific (NYSE:BSX) announced today that it entered into a definitive agreement to acquire the global surgical business of Lumenis for nearly $1.1 billion. Marlborough, Mass.–based Boston Scientific, entered into the agreement with an affiliate of Baring Private Equity Asia (BPEA) to acquire the privately-held company’s global surgical business, which develops and commercializes energy-based medical […]
Axonics, Micro Systems Technologies partners to make rechargeable SNM device
Axonics (NSDQ:AXNX) announced today that it entered into a strategic alliance with Micro Systems Technologies. Micro Systems Technologies (MST) manufactures printed circuit board assemblies for the Axonics r-SNM (sacral neuromodulation) system in Lake Oswego, Oregon, according to a news release. The newly minted strategic alliance expands the relationship between the two as the companies collaborate […]
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, […]
Corinth MedTech receives $5M venture loan
Horizon Technology Finance Corporation announced yesterday that it provided a $5 million venture loan to Corinth MedTech. San Jose, Calif.-based Corinth develops the FDA-cleared Veloxion system for treating symptoms related to benign prostatic hyperplasia (BPH), also known as TURP for enlarged prostate, according to a news release. Veloxion includes a resectoscope with an integrated camera, […]
Boston Scientific launches product for prostate cancer patients
Boston Scientific (NYSE:BSX) announced today that it has launched a product to help reduce radiation side effects in prostate cancer patients. The SpaceOAR Vue hydrogel is designed to create a temporary space between the prostate and rectum during radiation therapy, according to a news release. The hydrogel’s use also enables radiology staff to use computerized tomography […]
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 […]
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 […]
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 […]
