Indian medtech maker Meril Life Sciences said it has won the CE Mark for its MyVal-THV system, a transcatheter aortic valve replacement (TAVR) developed exclusively in India. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells […]
Motus GI lands FDA clearance for next-gen colon prep system
Motus GI (NSDQ:MOTS) today announced it has received FDA 510(k) clearance for the second-generation of its Pure-Vu colonoscopy device. Fort Lauderdale, Fla.-based Motus designed the original Pure-Vu device to attach to standard and slim colonoscopes to deliver a mixture of water and air to remove debris when patients haven’t completed their bowel prep. Pure-Vu GEN2 […]
Beta Bionics touts results of bionic pancreas system study
Beta Bionics’ iLet bionic pancreas system significantly increased the percentage of time that adults with Type 1 diabetes spent with glucose levels between 70–180 mg/dl when compared to usual care therapy, according to a new study. The study’s results also suggest that the iLet, using either the Senseonics (NYSE:SENS)Eversense continuous glucose monitoring system (CGM) or […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
Could this agreement boost continuous glucose monitor use?
An international panel of patients, physicians and researchers has agreed upon evidence-based target glycemic ranges for people who use continuous glucose monitors (CGMs) to control their diabetes. Announced today at the American Diabetes Association (ADA) conference in San Francisco, the International Consensus on Time-in-Range (TIR) was based on data from large pre-CGM clinical trials, CGM […]
ConvaTec helps fund wound management research grants
ConvaTec (LON:CTEC) said today that it has joined the European Wound Management Association (EWMA) to launch three grants for wound management research. The grants will be available to nurses, doctors and scientists working in the field of wound management. ConvaTec’s contribution of approximately $34,000 will be split across three themes: Process redesign to improve quality […]
Wyss Institute lands $131 million gift from founder
Harvard’s Wyss Institute for Biologically Inspired Engineering today announced a donation of $131 million, the latest gift from its founding entrepreneur and namesake, Hansjörg Wyss. Wyss Institute researchers draw on design principles from nature to solve some of the world’s most complex challenges in healthcare and the environment, and the institute commercializes those solutions. Among […]
Biotronik touts success of its resorbable magnesium scaffold
Biotronik said today that new data from a European patient registry strengthen the clinical evidence for its Magmaris resorbable scaffold device, its procedure success and safety profile. The target lesion failure (TLF) rate at 12 months was 4.7%. Cardiac death occurred in 0.1% of the 800 patients who received Magmaris and scaffold thrombosis in 0.6%. […]
Dexcom, Companion Medical will share glucose, insulin data
DexCom (NSDQ:DXCM) and Companion Medical have announced a collaboration to enable a direct exchange of continuous glucose monitoring (CGM) data from Dexcom with insulin data from InPen into both companies’ software applications. Companion made a partnership deal with Glooko this week to integrate data from its InPen smart insulin injection pen into Glooko’s diabetes data management system and mobile […]
Itamar Medical lands FDA clearance for disposable sleep apnea test
Itamar Medical (TASE:ITMR) said that its WatchPAT One fully disposable home sleep apnea test has received FDA 510(k) clearance. The device may save clinics time and money because it does not need return shipping, downloading, cleaning or preparation for the next study, according to Caesarea, Israel-based Itamar. “WatchPAT One is ideally suited for clinics and […]
Human factors and usability investment considerations for medtech companies
By Mark Tavano, Emergo Group Embedding human factors engineering (HFE) and usability studies early in medical device design and development cycles can yield benefits beyond regulatory compliance for manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
MassDevice Network
@MassDevice
LinkedIn
YouTube