1. Medtech Insight
  2. >>Business
  3. >>Strategy

Washington Roundup, April 2012

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover CDRH’s plans to expand its Medical Device Epidemiology Network and the potential impact of the JOBS Act on life sciences start-up companies.

The US Food and Drug Administration (FDA) plans to reach out to the public at a meeting this May to expand its nascent public-private Medical Device Epidemiology Network and discuss models for the network to improve device surveillance.

The network, also known as MDEpiNet, has an “overall mission to bridge the gaps that we currently have in the evidence for medical devices,” said Danica Marinac-Dabic, director of the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Strategy

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

Siemens Healthineers Widens FY25 EPS Range By €0.15 To Absorb Up To €300M In Tariff Costs

 
• By Shubham Singh

The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.

ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

More from Business

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

Siemens Healthineers Widens FY25 EPS Range By €0.15 To Absorb Up To €300M In Tariff Costs

 
• By Shubham Singh

The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By Marion Webb

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.