The FDA granted Blackrock Neurotech LLC breakthrough device designation for its Moveagain brain-computer interface (BCI) system as it targets 2022 for commercialization of the neural implant. Earlier this year, the Salt Lake City-based company received $10 million from investors including, Re.Mind Capital, Sorenson Impact and Facebook investor Peter Thiel to expand its clinical program. The company said its technology could be key to providing tetraplegic patients the ability to control devices directly from the brain. Read More
Aquyre Biosciences Inc., formerly known as Lltech, raised $19,945,534 in a series A2 preferred stock financing round to fund commercialization of its Celtivity system for on-site adequacy assessments of tissue biopsies. Ceros Financial Services acted as placement agent for more than $17.14 million of the funds raised in this round as part of its recently announced commitment to raise $100 million in the next 12 months for investment in early-stage medical technology and medical device companies. Read More
The Health Breach Notification Rule set forth by the U.S. Federal Trade Commission in 2009 was not initially directed toward health apps used strictly for non-medical uses, but the FTC has indicated it will enforce the rule for developers of these non-medical apps as well. The risk is substantial for these developers as the civil penalties for breaches can reach $44,000 per violation per day, which in the case of a mass breach could present a profound financial risk. Read More
PARIS – Incepto Medical SAS, in partnership with Marie-Lannelongue Hospital, is developing an automated system to measure maximum aorta diameter. Called ARVA (Augmented Radiology for Vascular Aneurysm), it’s hosted in the cloud and is CE marked as a class I device. “Our tool uses the first algorithm to provide automatic measurement of external aortic diameter along the entire aorta, from ascending aorta to the iliac arteries,” Antoine Jomier, co-founder and CEO of Incepto, told BioWorld. This new tool for radiologists and surgeons will be used to diagnosis and monitor aneurysms. Read More
TORONTO – Oncocyte Corp. launched Determaio, an immunotherapy response prediction test it said is “the first to comprehensively assess the tumor microenvironment.” This is important because of how smart cancer cells are in that microenvironment, Oncocyte CEO Ronnie Andrews told BioWorld, commandeering natural tissue repair biology and condensing immunological T cells so they back off attacking cancerous tissue. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosig, Quipt, Sourcemark Medical, Stevanato, Technion, Through the Cords. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avinger, Cardialen, Istar Medical, Nano-X Imaging, Paracrine, Softwave. Read More
