Reimbursement

Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.

AdvaMed’s new online clock documents the time since CMS promised to replace MCIT, a program guaranteeing coverage for FDA-cleared breakthrough devices.

Ekso Bionics’ exoskeleton received a final payment determination from the Centers for Medicare and Medicaid Services, paving the way to faster rehabilitation for more patients.

This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.

Dozens of researchers signed a letter condemning the AvertD test from SOLVD, which looks for genes that may contribute to a propensity toward opioid addiction. But the FDA and the manufacturer both say the test is effective.

Abbott wins FDA approval for TriClip regurgitation therapy, which will compete against Edwards Lifesciences’ recently approved Evoque transcatheter tricuspid valve replacement device. Two analysts expect Tricuspid will be eligible for a new technology add-on payment, which will be positive for Abbott.

Medtech Insight spoke to QliqSOFT executive Bobbi Weber about the advantages of collecting patient data though chatbots, and how the technology can make conversations at the doctor’s office a little more manageable. 

Collaboration with Japan and Europe could help ease the development path for pediatric devices, cardiovascular device office director Bram Zuckerman said at a recent conference. Zuckerman also spoke on other cardiac device priorities at the FDA.

Axena Health recently secured a HCPCS code for its female incontinence device Leva. For CEO Eileen Maus, this is just the latest in a string of successes across the women’s health, or femtech, sector. 

This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.

The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.

NICE has recommended endoscopic sleeve gastroplasty for the treatment of obesity in adults.

VC funding will remain challenging for many in the health care industry, Silicon Valley Bank’s market manager Milo Bissin told attendees at the recent DHIS West conference. Companies focusing on promising areas such as AI-powered technologies, women’s health and value-based care likely have the best chances to draw investors’ attention.

The Innovative Device Access Pathway pilot has launched in the UK with eight new promising medical technologies. The cohort is overwhelmingly diagnostic-focused, with innovative testing for Alzheimer’s, stroke, and liver cancer, amongst others.

The US government is said to be investigating a sudden spike in Medicare billings for urinary catheters, which jumped from $153m in 2021 to $2.1bn in 2023.

Implementing acts for Joint Clinical Assessments and exchange of information with the EMA were on the agenda of this month’s Member States Coordination Group on HTA meeting. The discussion marks considerable progress towards the application deadline in January 2025.