The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.

Benjamin Wallfisch, a senior attorney at the Office of the Inspector General in the US Department of Health and Human Services, recently discussed how companies can avoid apparent violations of anti-kickback law while hosting educational programs.

In this week’s podcast,  EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union. Topics include discussion of ISO 13485, ongoing industry concerns with MDR implementation, and the Eudamed database expansion.

The US FDA’s most recent guidance revises UDI requirements for class I and unclassified medical devices the agency issued in July. Class I devices categorized as consumer health products will be exempt from some submission requirements.

The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.

The consequences of China’s volume-based, centralized procurement of medical supplies, initiated in 2018, are starting to become clear, according to reports from Omdia.

The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.

Benjamin Wallfisch, a senior attorney at the Office of the Inspector General in the US Department of Health and Human Services, recently discussed how companies can avoid apparent violations of anti-kickback law while hosting educational programs.

The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.

Dexcom is making CGM data available through consumer devices starting with Garmin’s smartwatches and bicycle computers.

A new report from Informa's Meddevicetracker highlights strong projected growth in the market, explaining the underlying reasons why.

Better Therapeutics is developing prescription digital therapeutics for behavioral therapy to address the root causes of cardiometabolic disease.

Massachusetts’ Medicaid program will cover reSET and reSET-O prescription digital therapeutics for the treatment of substance abuse disorder and opioid use disorder.

The French company is promoting its ScanWatch as the first wearable device to receive FDA clearance for both atrial fibrillation detection through medical grade ECG and measuring SpO2 levels from the wrist.

In a panel discussion at The Medtech Conference, hosted by AdvaMed, CEOs discussed the challenges, benefits and technicalities surrounding an IPO.

Dexcom is making CGM data available through consumer devices starting with Garmin’s smartwatches and bicycle computers.

The French company is promoting its ScanWatch as the first wearable device to receive FDA clearance for both atrial fibrillation detection through medical grade ECG and measuring SpO2 levels from the wrist.

Medtronic’s robotic-assisted surgery system earned a CE mark approval for urologic and gynecologic procedures, which make up about half of all robotic procedures.

MindMaze, which designs VR-based games to help people retore motor function after stroke or brain injury, will use the proceeds to accelerate marketing of its platform and run clinical trials.

September has been full of cardiovascular technology news, including announcements from Biotronik and Biosense Webster. Here are a few of the highlights.

Medtech Insight sat down with Think Surgical’s CFO Paul Weiner at the recent AAOS conference to discuss the roll-out of the next-generation TSolution One TKA robot and company plans.