Co-Diagnostics and ReadyGo have begun feasibility work combining portable blood sample preparation with the Co-Dx PCR platform, using decentralized Ebola detection as the first test case.
ZBeats has received FDA 510(k) clearance for ZBPro Diagnostic v2.0, expanding its ECG-analysis platform from short recordings to continuous datasets lasting as long as 14 days.
Synergy Spine Solutions reports 87.1% composite clinical success with the FDA-approved Synergy Disc versus 56.6% with ACDF at two years in its U.S. IDE study.
A meta-analysis covering more than 14 million procedures found several recovery advantages associated with da Vinci robotic surgery, while longer operating times and the study’s largely observational evidence base keep hospital economics central to the debate.
Abbott’s Libre Duo 10 Day has received FDA De Novo authorization as the first integrated continuous glucose and ketone monitoring system in the United States, potentially extending CGM from daily glucose control into early diabetic ketoacidosis warning.
CMS has modernized Medicare coverage for transcatheter aortic valve replacement, ending evidence-development requirements for symptomatic severe aortic stenosis while creating a pathway for certain asymptomatic patients.
Stryker is extending its Prophecy patient-specific surgical planning platform, already used in more than 100,000 ankle cases, to the Incompass Total Ankle System as it builds a more connected Foot & Ankle ecosystem.
GE HealthCare has launched CareIntellect for Operations, an AI-enabled SaaS application designed to predict hospital capacity constraints up to 72 hours ahead and recommend actions around discharge, imaging, transfers and staffing.
Siemens Healthineers has made the CN-3000 and CN-6000 hemostasis systems available for U.S. patient testing, targeting automation, laboratory consolidation and recurring assay revenue as its broader Diagnostics business battles weaker growth.
FDA clearance for Medtronic’s LigaSure RAS Maryland instrument adds a familiar vessel-sealing technology to Hugo, strengthening the company’s effort to build a broader robotic surgery ecosystem around instruments, procedures and recurring revenue.