/PRNewswire/ — EmbracePlus by Empatica has received the European CE mark as a Class lla medical device, for its ability to consistently provide quality…

Neuroelectrics is planning a pivotal test of its wearable medical device, which delivers brain electrical stimulation to treat epilepsy. The startup’s Series A round of funding was led by Morningside Ventures.

Proscia, a provider of digital and computational pathology solutions, and Unilabs, a provider of diagnostic services, have established a strategic partnership to accelerate the adoption of artificial intelligence (AI) in routine pathology practice.

AlgoDx, a clinical stage medical device software company, has announced obtained the CE mark for NAVOY Sepsis. This medical device is intended to assist medical staff at Intensive Care Units (ICU) to predict sepsis in adult ICU patients.

The round is the largest fundraising to date for a privately held medtech company in Europe. Credit Suisse Entrepreneur Capital Ltd. and Endeavour Vision led the financing with significant participation from new investors, including Tandem Diabetes Care, Inc., Ypsomed Group, Federated Hermes Kaufmann Funds, Kingdon Capital, and GMS Capital, as well as existing investors, Schroder & Co. Bank SA, and VI Partners. The company will use the funds to advance commercial plans for CeQur Simplicity, including a phased commercial launch strategy that includes a limited market release in 2021. CeQur Simplicity is a simple, three-day, wearable insulin device for discreet, convenient and injection-free bolus dosing. One Simplicity patch holds up to 200 units of rapid-acting insulin administered in two-unit increments and replaces, on average, nine mealtime injections over three days. Clinical research has shown that nearly 90% of patients using CeQur Simplicity reported following their insulin regimen better as compared to multiple daily injections MDI. The device is clinically proven and both FDA cleared and CE-marked. CeQur is headquartered in Horw close to Lucerne. CFO of the company is Douglas Günthardt, the former CEO of Siegfried and board member of the Ricola Group. “CeQur Simplicity offers a simple solution to a major barrier for many people who need mealtime insulin. This financing, which is transformative for CeQur, provides additional validation for the value of CeQur Simplicity as a simple, convenient and discreet bolus insulin-delivery device that is designed to address the burden of multiple daily injections for over 3 million Americans – and many more individuals around the world,” said Richard Mott, Chairman of the Board at CeQur. (Press release / Stefan Kyora) Photo: CeQur Simplicity

FDA’s Center for Devices and Radiological Health will host a free workshop on April 13 for industry.

From January 1, 2021, the transition period after Brexit ended, and the Medicines and Healthcare products Regulatory Agency (MHRA) took on the role as the UK’s standalone medicines and medical devices regulator.

Alimetry, a digital healthcare and diagnostic devices start-up, announced today that it has achieved CE Mark for its first product, a pioneering medical device for enabling diagnosis of gastric diseases.

The stress and impact that ICUs can have on the mental health of patients typically result in prolonged hospital stays.Troubling cycles typically ensue as soon as patients experience trauma either……

The FDA today issued a ruling that amends medical device classification regulations related to the 21st Century Cures Act.