RSS

FDA

On day one of Med-Tech Innovation Expo, Ken Block, president and founder of Ken block Consulting will discuss recent drafts and final FDA guidance on a variety of topics. more

News

Digital health company DarioHealth has been granted pre-market notification clearance for the Lightning-enabled version of its Blood Glucose Monitoring system, enabling the use of the Dario app on the latest iPhones. more

News

Google is partnering with connected products designer Flex on a cloud-based platform for medical device analytics. more

News

One-day event in March aims to support medical device manufacturers through the implementation. more

Features

A doctor in the US has been suspended after allegedly reusing disposable single-use anal catheters, according to the news site, NJ. more

News

Provider of respiratory monitoring technology PMD Solutions has been selected to join the NHS Innovation Accelerator Programme. more

News

The FDA has issued new guidance on the use of 3D printing in response to the technology’s growing adoption by the healthcare industry. more

News

The first medical device accessory for the Apple Watch has been approved for use by the FDA. more

News

The FDA has approved a medical device system that can make small adjustments to intraocular lens’ power, potentially giving patients better vision when not using glasses. more

News

A new robotically-assisted surgical device (RASD) that can help with minimally invasive surgery has been cleared by the FDA. more

News

Last month Puerto Rico was devastated by hurricane Maria which wiped out much of the island’s infrastructure and killed 51 people. Most of the island is still without power and basic services are in dire need. more

News

Warren Stacey of labelling specialist Prisym ID examines unique device identification implementation to date, and offers best practice guidance for compliance. more

Features

Pall Medical – a division of filtration group Pall Corporation – says that its ‘QPoint’ water filter capsules have received FDA 510(k) clearance as a class ll medical device. more

News

A number of medical manufactures based in Puerto Rico have responded to the impact and damage caused by hurricane Maria. more

News

The US Department of Homeland Security issues warning over the devices, which it says could be hacked. more

News

The Advanced Medical Technology Association (AdvaMed) has responded to the FDA’s recent Digital Health Innovation Action Plan, commending the initiative for its new regulatory approach to medical device software. more

News

The FDA has released guidance for medical device makers on the use of real-world data (RWD) and real-world evidence (RWE) in gaining approval for their products. more

News

Researchers in the US report that too few medical device manufacturers factor in the influence of their users' sex, age, or race on safety and effectiveness. more

News