Some of the industry news from last week that Medtech Insight is tracking: The FDA granted its breakthrough status to Toku's Clair AI technology for finding markers of cardiovascular disease in retinal scans. Dupont is partnering with STMicroelectronics on a new patch sensor technology, ReWalk secures Medicare coverage for its exoskeleton, and more.
ReWalk Robotics announcedyet another milestone in its efforts to solidify Medicare coverage and help more people with spinal cord injuries gain access to its exoskeleton technology.
After announcing that the Centers for Medicare and Medicaid Services ruled that exoskeletons would be covered in the Medicare brace...
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
A Deep Dive into Evidence-Based Guidelines, Clinical Considerations, and Evolving Practices for Post-SBRT Imaging in Spinal Tumor Patients
This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.
The EU IHI’s eighth call for action also encourages innovative medtech approaches to tackling cardiovascular disease and osteoarthritis and patient-centered endpoints that can benefit from advancements in digital health.
