The FDA today issued a notice saying the recall of Medtronic McGrath Mac video laryngoscopes is Class I, the most serious kind. Medtronic in October warned on stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties. The company initiated a recall as a result of the stolen, defective products. The company […]
Imaging
Elekta receives $40M radiation tech order in India
Elekta announced today that it received an order worth approximately $40 million for its full suite of hardware and software. Stockholm, Sweden-based Elekta develops precision radiation therapy to treat cancer. The FDA cleared its latest offering, the Comprehensive Motion Management (CMM) with True Tracking and automatic gating, earlier this year. Krishna Institute of Medical Sciences […]
Philips picks up funding from Gates Foundation for AI-powered maternal health ultrasound
Philips announced today that it received a second round of funding from the Bill & Melinda Gates Foundation for its ultrasound technology. The funding goes toward accelerating the global adoption of AI algorithms on the Philips Lumify handheld ultrasound system. Philips’ system utilizes AI to simplify key measurements to identify abnormalities during pregnancy. This can […]
NeuroOne expects FDA nod for neuro ablation tech next year
NeuroOne (Nasdaq:NMTC) announced today that it responded to FDA questions regarding the 510(k) submission of its OneRF ablation system. Eden Prairie, Minnesota–based NeuroOne submitted OneRF for FDA clearance in June. It’s the company’s first therapeutic device. The technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects […]
HistoSonics scores reimbursement win for sonic beam therapy
HistoSonics announced today that the Centers of Medicare & Medicaid Services (CMS) set a new payment rate for its tumor treatment. Minneapolis-based HistoSonics develops a histotripsy treatment for liver tumor procedures. Last month, the FDA granted de novo authorization for its Edison system and novel histotripsy therapy platforms. Edison, an image-guided sonic beam therapy system uses […]
Stereotaxis performs first surgical robot procedure with Abbott cardiac mapping tech
Stereotaxis (NYSE:STXS) today announced the first treated patients in the U.S. as part of its surgical robotics collaboration with Abbott . In May, the two companies entered a deal aimed at taking robotic electrophysiology to the next level. It sought to integrate the Abbott EnSite X EP 3D heart mapping system — with Stereotaxis’ robotic […]
PCI guidance tech from Philips delivers positive study results
Philips today announced study results supporting its instant wave-free ratio (iFR) in guiding percutaneous coronary intervention (PCI). Amsterdam-based Philips offers iFR as a pressure-derived index to assess coronary blockages during interventional procedures. iFR avoids the use of hyperemic agents — drugs that maximize blood flow but can impact the patient experience. Dr. Matthias Götberg presented […]
Butterfly Network is bringing its ultrasound tech to the BCI space
Butterfly Network (NYSE:BFLY) announced today that it entered into a five-year co-development deal with Forest Neurotech. The deal combines Butterfly Network’s portable ultrasound technology with Forest Neurotech’s minimally invasive brain device. Forest, a deep tech research company, develops a device for imaging and stimulating the brain with ultrasound. Forest Neurotech develops an ultrasound-based brain-computer interface […]
GE HealthCare announces cardiac imaging collaboration with Boston Scientific
GE HealthCare today announced plans to showcase a number of innovations and unveiled a new imaging collaboration. The company plans to share its latest innovations at the 2023 Transcatheter Cardiovascular Therapeutics conference (TCT). TCT takes place in San Francisco this week. Among the new developments is a new partnership with Boston Scientific. GE HealthCare intends […]
GE HealthCare, Novo Nordisk partner to treat diabetes and obesity with ultrasound
GE HealthCare and Novo Nordisk are partnering up to advance the clinical and product development of peripheral focused ultrasound (PFUS) to treat chronic diseases like type 2 diabetes and obesity. As part of the collaboration, GE HealthCare and Novo Nordisk will use their respective expertise in ultrasound medical technology and metabolic disease treatment and management […]
Interventional Systems wins new FDA nod for surgical robot with CT guidance
Interventional Systems announced today that the FDA granted a new 510(k) clearance for its Micromate surgical robot system. The new clearance enables U.S. marketing for percutaneous procedures using computed tomography (CT) optical navigation. These include biopsies and ablations for diagnosing and treating conditions in the chest, abdomen and musculoskeletal structures. Interventional Systems said the clearance […]