Cionic Inc. doubled its funding to date with a $12.5 million series A round led by Bluerun Ventures. The cash infusion will support the manufacturing and delivery of the company’s Neural Sleeve, development of additional products on its human augmentation platform and expansion of the team. The Neural Sleeve received FDA clearance in February and is designed to help individuals with impairments caused by multiple sclerosis, stroke, cerebral palsy and other diseases retain or regain mobility. Read More
Stryker Corp. reported the launch of its Q Guidance system for spine applications. The system leverages new optical tracking options via a redesigned camera with the advanced algorithms of the newly released Spine Guidance software. Read More
Precisis GmbH is ready for market rollout after securing CE marking for its minimally invasive brain pacemaker for treating drug refractory epilepsy. Read More
The U.S. Congress passed a five-year reauthorization of the Medical Device User Fee Amendment (MDUFA) agreement, the fifth iteration of this user-fee agreement since the system's implementation in 2002, after many months of back and forth with the med-tech industry. The extension passed as part of a temporary spending bill needed to avoid a partial government shutdown ahead of Friday’s deadline. The spending bill passage gives lawmakers a reprieve until after the midterm elections when they'll need to figure out a longer-term funding plan for the fiscal year ending Sept. 30, 2023. Read More
In a development that is a potential boon for wearables and other sectors of the digital health industry, the U.K.’s NICE has petitioned the National Health Service (NHS) to expand its coverage of devices that monitor patients with Parkinson’s disease. That data would be used by NICE to inform a health technology assessment that might ultimately boost sales of these devices if the data suggest a strong benefit to patients and to the U.K. health care budget. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GE Healthcare, Intuitive Surgical. Read More
