Outset Medical said today that it won a contract from the U.S. Health & Human Services Dept. for using its Tablo hemodialysis systems in response to natural disasters. Tablo is designed to use wireless data, sensor-based automation and an animated touchscreen to make dialysis care accessible in-home, requiring only an electrical outlet and tap water […]
ControlRad drums up $15m Series B round
ControlRad said today that it completed a $15 million Series B round for the commercial launch of its Trace system for reducing radiation in fluoroscopically guided procedures. Norcross, Ga.-based ControlRad’s Trace system is the first FDA-cleared technology that can be integrated into existing mobile C-arms to reduce the ionizing radiation that can occur in FGP. […]
Meditrina raises $13m to commercialize Aveta device
Meditrina said yesterday that it completed a round of equity financing worth $13 million for the commercialization of its Aveta System for treating intrauterine pathologies. The San Jose, Calif.-based company’s Aveta system won FDA 510(k) clearance in May; the company plans to put the $13 million toward the platform’s market launch. The Aveta system is […]
NIH puts up $20m for new medtech hubs
The National Institutes of Health said today that it awarded $20 million to fund five medtech hubs to speed the translation of biomedical developments into commercially viable products. The new centers join the Research Evaluation & Commercialization Hubs, which aim to expand a national network of proof-of-concept centers that links 34 academic institutions, according to […]
Philips touts Stellarex balloon study
Royal Philips (NYSE:PHG) said today that third-party data from worldwide clinical trials for the Stellarex drug-coated balloon showed that there was no difference in mortality between patients treated with the device compared to uncoated percutaneous transluminal angioplasty. The primary analysis consisted of three-year patient-level data from the Illumenate pivotal trial and the Illumenate European randomized controlled […]
Imbed Biosciences wins $1.5m NIH grant
Imbed Biosciences said last week that it received a $1.5 million grant from the National Institutes of Health to develop a bioresorbable, antibacterial wound dressing. Fitchburg, Wis.-based Imbed said the two-year Small Business Innovation Research grant, from the NIH’s National Institute for Arthritis & Musculoskeletal & Skin Diseases, is for R&D on a bioresorbable wound […]
Baxter touts Sharesource home dialysis study
Baxter (NYSE:BAX) said today that patients treated with automated peritoneal dialysis cyclers and its Sharesource remote patient management platform showed significant reductions in hospitalization rates and hospitalization days. The results of a study comparing peritoneal dialysis patients managed with Sharesource to those not using the remote platform at home showed a 39% reduction in hospitalizations for […]
Bay Labs rebrands as Caption Health
Bay Labs said today that it is renaming the company Caption Health and rebranding its flagship technology, EchoGPS, as Caption Guidance. The San Francisco-based company plans to incorporate Caption Guidance technology into compatible ultrasound devices and offer that product to the market as Caption AI. Caption AI is designed to allow for quick and accurate […]
Ra Medical recalls Dabra laser catheters
Ra Medical Systems (NYSE:RMED) last week began a voluntary recall of its Dabra laser system single-use catheters due to a calibration problem. The Dabra laser system has experienced inconsistent performance because of catheters that fail to calibrate before procedures, which can result in a temporary delay, according to an SEC filing. Ra Medical’s review of the […]
FDA clears new drill for Neocis Yomi robot-assisted dental surgery device
Neocis said yesterday that it received FDA 510(k) clearance for a new robot-assisted drill to be used with its Yomi dental surgery system. The Miami-based company said the clearance will lead to an easier workflow and provide enhancements to the surgeons’ drilling experience. Yomi won FDA clearance in March 2017 for dental implant procedures, becoming […]
KPMG/RAPS survey highlights MDR barriers
According to a survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS), achieving MDR compliance by the May 2020 deadline remains difficult for companies, mainly due to a lack of resources. The survey, which closed on June 21 this year, takes into account the responses from 230 medical device organizations, 91% of which […]
