The Food and Drug Administration(FDA) moved Monday to put sales restrictions on a Bayer birth control implant that has been a target of consumer criticism.
A new visor-like device worn by patients can help providers and emergency medical personnel detect a stroke that requires comprehensive care within seconds and with greater than 90 percent accuracy.
The first quarter of 2018 was light on mergers and acquisitions compared to previous quarters, but those that did crop up were significant, including major companies like Fitbit, Allscripts, Roche, and Johnson & Johnson.
The FDA's Center for Devices and Radiological Health plans to expand its digital health pre-certification pilot program by the end of 2018, the center's associate director for digital health Bakul Patel said March 22, according to Regulatory Focus.
This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval(PMA) from the FDA.
Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
SafeHeal, an early-stage medtech company specialized in digestive surgery and focused on the development of the Colovac device, announces today that it has closed a €6 million Series A financing round led by Sofinnova Partners.
Medical device design agency, Team Consulting, has created the Convesaid haemostat spray device that stops bleeds during surgery.
Cedars-Sinai will be testing a digital pain-reduction kit, which includes VR glasses and mHealth wearables, to see if mobile health technology can replace opioids for people recovering from workplace injuries.
Science 37, a trailblazing company focused on “site-less” clinical trials, announced today a strategic alliance with Novartis that will support the development of its new decentralized clinical trial (DCT) offerings. This three-year commitment will enable a more extensive portfolio of trials powered by the Network Oriented Research Assistant (NORA®), Science 37’s proprietary technology platform that enables patients to participate in clinical research regardless of their geographical location using mobile devices and telemedicine services.
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