The medical device company Distalmotion SA has hit a regulatory milestone in the commercialization of its surgical robot, Dexter, earning a CE mark in Europe. The Dexter surgical robot is built with the aim of allowing surgeons to take a hybrid approach to minimally invasive surgery, using the robot for tasks such as suturing and complex dissections while switching to a laparoscopic approach for stapling and basic dissections. Read More
Bioserenity SAS has gained U.S. FDA clearance for the Neuronaute electroencephalography (EEG) system and Icecap EEG wearable device, which aim to help physicians remotely monitor and assess electrical brain activity of people with epilepsy. The company noted that the Icecap and Neuronaute system will facilitate access to care in a variety of settings, including rural and remote environments. Read More
The U.S. FDA’s safer technologies program, or STeP, is designed in part as a complement to the breakthrough devices program, but the September 2019 draft guidance lent little clarity as to what might constitute a significantly safer device. The Jan. 5, 2021, final guidance does little to clarify that question, however. Read More
Emboline Inc., which is developing technology to reduce the chance of stroke during transcatheter heart procedures, completed a $10 million series C financing. The funds are earmarked to gain initial commercial approval of the company’s Emboliner device and to launch a U.S. pivotal study. The round, which included new and existing investors, follows a $5 million bridge round of financing that closed last January. Read More
A new $23 million in funds gives Brainbox Solutions Inc. a head start as it begins enrollment in the pivotal clinical trial of its mild traumatic brain injury (TBI) diagnostic and prognostic test. Bioventures Investors took the lead in the series A financing. The Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, and Astia Angels participated in the fundraising round along with qualified investors including the Cleveland Cavaliers' Kevin Love, a mental health advocate. Read More
New hires and promotions in the med-tech industry, including: Biodesix, Biolife Solutions, Ceretrieve, Color, CS Analytical Laboratory, Cvrs, Inari Medical, Locate Bio, Novacyt, Tela Bio. Read More
Med-tech firms raising money in public or private financings, including: Adapthealth, Canary Medical, Color, Pulse Biosciences, Viewray, Volta Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Bioserenity, Nirmidas Biotech, Spark Biomedical, Trinity Biotech. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO says wound care spending dropped between 2016 and 2018; FDA updates COVID testing data; May 2019 Q-sub guidance appears in final form. Read More
Keeping you up to date on recent developments in oncology, including: Cellular ‘backpack’ boosts activity of macrophages against cancer; Hardware + software = slide-free histology; Researchers wary of social media for clinical trial recruitment; Peptides team up with nanowires to detect cancer exosomes. Read More
