Hologic (NSDQ:HOLX) said yesterday that its Brevera breast biopsy system with CorLumina imaging tech won CE Mark clearance in the E.U. The real-time breast biopsy and verification system is designed to boost accuracy and improve the patient experience by streamlining the biopsy process, according to Hologic. The technology combines tissue acquisition, real-time imaging, sample verification and […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA approves clinician app for Medtronic’s SynchroMed II drug pump
The FDA has approved a new clinician application for Medtronic‘s (NYSE:MDT) SynchroMed II intrathecal drug pump. The newly-approved programmer was designed to give doctors visual tools and improved workflows to simplify therapy management. The medtech titan’s implantable pump, which has been problematic in the past, delivers drugs directly to the fluid around the spinal cord. Get the full […]
Gynesonics touts pivotal IDE Sonata trial results
Gynesonics today released results from the pivotal FDA investigational device exemption cleared trial for its Sonata system designed for the incision-free treatment of uterine fibroids, touting a 99% freedom from surgical reintervention for heavy menstrual bleeding. The Redwood City, Calif.-based company’s Sonata trial is a prospective, longitudinal, multi-center trial exploring the safety and effectiveness of […]
Novo Nordisk’s once-weekly diabetes injection cleared in Canada
Health Canada has approved Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide injection as an adjunct to diet and exercise that can help adults with Type II diabetes control their blood sugar levels. The drug, Ozempic, is a GLP-1 receptor agonist and won FDA approval in the U.S. in December. Get the full story at our sister site, Drug Delivery Business […]
Nevro wins FDA nod for next-gen Senza II SCS
Nevro Corp. (NYSE:NVRO) said yesterday it won FDA approval for its next-generation Senza II spinal cord stimulation system. The Redwood City, Calif.-based company said the Senza II SCS system is designed to deliver HF10 therapy through a smaller footprint while maintaining the durability and performance of the current generation device. Both the next-gen device and previous versions […]
Attune Medical wins 510(k) clearance for drug-delivery model of EnsoETM esophageal device
Attune Medical said today that it won 510(k) clearance from the FDA for a new model of its EnsoETM device capable of administering tube feeds or medication while regulating a patient’s temperature through the esophagus. The newly-approved model allows clinicians to maintain a patient’s core temperature while simultaneously administering fluids, eliminating the need for a separate […]
Varian inks Chinese cancer care deal with Ping An, wins Taiwanese nod for Halcyon
Varian Medical (NYSE:VAR) said today it signed a strategic partnership deal with Ping An Health Technology to explore expanding cancer care in China, and that it won Taiwanese approval for its Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system. In its deal with Ping An, Palo Alto, Calif.-based Varian said both companies will explore using artificial […]
Intersect ENT reports Q4, full-year revenue prelims
Shares in Intersect ENT (NSDQ:XENT) held steady today after the company reported preliminary data for its fourth quarter and full-year revenues. The Menlo Park, Calif.-based company said it expects to reel in $96.1 – $96.3 million in revenue for the full year of 2017, up 22% from 2016. Intersect also pegged its fourth-quarter revenue between $29.3 million […]
pSivida seeks FDA nod for 3-year treatment of posterior segment uveitis
pSivida (NSDQ:PSDV) has submitted a new drug application to the FDA for its Durasert implant that provides three years of treatment for people with posterior segment uveitis. The drug-delivery product’s NDA includes data from two Phase III trials, both of which met their primary efficacy endpoints after six months. Get the full story at our sister […]
Planmed Oy wins FDA nod for Clarity 2D digital mammography system
Planmed Oy said yesterday it won FDA approval for its Planmed Clarity 2D full-field digital mammography system. The company said the Clarity 2D system is designed to provide improved image quality, optimal ergonomics and usability for breast cancer screenings. The system also supports diagnostic work-up examinations and biopsy procedures, Planmed said. “We are excited that […]
BioCardia files 2nd FDA IDE bid for CardiAMP chronic myocardial ischemia, refractory angina study
BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy of chronic myocardial ischemia and refractory angina as it seeks a second indication. The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate the […]