The US Food and Drug Administration (FDA) on Tuesday finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug and device reform—the Opinion on Strengthening the Reform of the Drug and Medical Device Review and Approval Process to Encourage Drug and Medical Device Innovation (“Opinion 42”).
Managing your medical device product development project can be a daunting task. There are regulations and paperwork to manage, along with expectations such as deadlines or goals for getting the device to market.
Materials are one of the most common causes of failure in medical devices, especially for plastic. Records show that material failure is responsible for 30 to 40 percent of all FDA recalls on medical devices.
Ddu (www.drugdu.com) is the world's first B2B online platform focused on the cross-border trade of pharmaceuticals and medical devices. As a pioneer in the industry, Ddu is committed to accelerating the circulation of the pharmaceutical and medical device trade around the world, making it simpler, easier and more efficient.
Edmond De Rothschild Investment Partners has raised €345 million ($430 million) for its latest fund. The haul makes BioDiscovery 5 the largest fund dedicated to biotechs and medical devices in Europe and tees up Edmond De Rothschild to invest in 15 to 17 companies.
Emaptica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone.
More than nine in 10 nurse managers see voice recognition and telehealth technologies intensifying over the next five years, while secure text messaging, voice communication and photographing wounds and skin conditions will be nearly universal. Major growth is expected in areas like remote patient monitoring.
Wearables, like smartwatches and fitness trackers, are popular with business professionals, and for good reason. The devices can collect data and provide insights, allowing wearers to track their fitness and productivity to reach their goals faster.
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