GE Healthcare (NYSE:GE) announced that it received FDA 510(k) clearance for its Ultra Edition package on Vivid cardivascular ultrasound systems. The Ultra Edition package on Vivid cardiovascular ultrasound systems includes new features that are based on artificial intelligence (AI) designed to enable clinicians to acquire faster, more repeatable exams on a consistent basis, according to a […]
Imaging
SpectraWave names new CEO
Coronary artery disease (CAD) treatment startup SpectraWave announced today that it has appointed Eman Namati as its new CEO. Bedford, Mass.-based SpectraWave is developing a medical imaging platform that uses photonics to improve CAD outcomes. Namati joins with more than a decade of experience leading the development and launch of highly technical medical imaging products, […]
Olympus gains 510(k) clearance for colonoscopes
Olympus (TYO:7733) announced that it has received FDA 510(k) clearance for its PCF-H190T and PCF-HQ190 colonoscopes. Center Valley, Pa.-based Olympus’ two newly cleared colonoscopes provide an extension to the existing capabilities of physicians to diagnose and treat disorders of the gastrointestinal tract, according to a news release. PCF-H190TL/I is a slim, short-bending scope designed for tighter […]
Imbio, Genentech partner on AI for lung imaging
Imaging AI company Imbio has partnered with the Roche Group’s Genentech business to develop quantitative imaging diagnostics for lung diseases. The multi-year agreement, announced yesterday, leverages Minneapolis-based Imbio’s expertise to build and deploy medical imaging AI technology for use in research, clinical trials and clinical practice. “We are excited to partner with Genentech and we […]
The top 10 medical disruptors of 2021
For the past 18 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Will Morris, executive medical director of Cleveland Clinic Innovations, and Dr. Akhil Saklecha, managing […]
Medtronic to acquire Avenu Medical
Medtronic (NYSE:MDT) announced today that it plans to acquire endovascular arteriovenous (AV) fistulae creator Avenu Medical. Terms of the transaction were not disclosed by the medtech giant or the soon-to-be acquired San Juan Capistrano, Calif.-based company, which focuses on the endovascular creation of AV fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis, according to […]
GE Healthcare kicks off AI in imaging project in France
GE Healthcare (NYSE:GE) announced that it launched its AI DReAM project for facilitating artificial intelligence use in medical imaging. The consortium is slated to gather French companies, research labs and clinical centers to aid in the development of AI in the imaging space. With €13 million in funding from the “Investments for the Future” program led […]
FDA allows at-home capsule endoscopy administration
CapsoVision announced that it received FDA enforcement discretion to allow at-home administration of its CapsoCam Plus. Saratoga, Calif.-based CapsoVision’s CapsoCam Plus is a small bowel capsule endoscope intended for the visualization of the small bowel mucosa in adults. It does not require external equipment to be worn by the patient and it can be returned […]
Varex commences $300m offering
Varex Imaging (NSDQ:VREX) announced that it commenced a private offering of $300 million in senior secured notes. Proceeds from Salt Lake City-based Varex’s notes, due 2027, are earmarked for the payment in full all amounts outstanding under its existing credit facility, including its term loan and revolving credit facility. Another use for the proceeds is general […]
Pentax launches high-def bronchoscopes in U.S.
Pentax Medical announced today that it launched its EB-J10 Series bronchoscopes in the U.S. after receiving FDA 510(k) clearance. The Hoya (TYO:7741) subsidiary’s EB-J10 Series bronchoscopes are designed to provide high-definition visualization of the bronchus and have compatibility with the simultaneously launched Defina video processor for supporting pulmonology practices with advanced imaging. Montvale, N.J.-based Pentax’s EB-J10 […]
NanoVibronix device gains FDA nod for import to U.S.
NanoVibronix (NSDQ:NAOV) announced today that it received FDA enforcement discretion for the U.S. distribution of the UroShield device. According to a news release, the FDA exercised its enforcement discretion, giving Elmsford, N.Y.-based NanoVibronix’s UroShield an intended use code (IUC), clearing the way for the import of the system to the U.S. amid the COVID-19 pandemic. UroShield […]