MamaLift Plus, 510(k)-cleared by the FDA in April as the first prescription digital therapeutic for treating postpartum depression, will soon be available for download on the App Store or Google Play. Announced 28 August, Curio has raised $10m in Series A funding to bolster commercial activities.
Women experiencing postpartum depression – estimated to affect one in seven new mothers – soon may be able to benefit from a non-pharmaceutical alternative for treatment: Curio Digital Therapeutics’ MamaLift Plus.
The US Food and Drug Administration granted Curio 510(k) clearance in April for MamaLift Plus, a first-of-its-kind, prescription-only digital therapeutic...
When a large medtech company sets up a venture fund, it typically invests in technologies that are adjacent to its pre-existing portfolio. Intuitive Surgical’s approach is different.
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.
Spain has one of the highest incarceration rates in Europe, with 160 individuals imprisoned per 100,000 residents. In 2020, 43,494 people were incarcerated in facilities not managed by regional health authorities — essentially all regions except Catalonia, the Basque Country, and Navarra.
The medtech companies navigate tariffs through a mix of proactive manufacturing moves, financial planning and global supply chain adjustments. Medtech Insight combined comments from executives made during their first-quarter earning calls to get an industry pulse check on how the surge of tariffs im
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation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.
