Medical Device Developments Weekly: 04/10/23

The latest insight and analysis from the global medical device market from the last week courtesy of Medical Device Developments

Enable Injections secures FDA approval for Empaveli Injector

Enable Injections, Inc. has secured the US FDA approval for Empaveli Injector, based on its enFuse technology.

Empaveli Injector is a compact, single-use, on-body device designed to enable the subcutaneous self-administration of Empaveli (pegcetacoplan), a prescription medicine for paroxysmal nocturnal hemoglobinuria (PNH)

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NordicNeuroLab Selects USound GmbH as A MEMS Speaker Supplier for Its New MRI-Compatible Headphones

USound GmbH, a fast-growing company providing advanced audio solutions, has been selected by?NordicNeuroLab, the leading global producer of medical equipment for functional magnetic resonance imaging (MRI) studies, as a MEMS microspeaker supplier for the production of its new MRI-compatible headphones.

The medical headphones will significantly reduce MRI noise and provide patient comfort as well as improving patient – operator communication during MRI examinations.

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ONWARD completes first-in-human implant of ARC-IM Stimulator with BCI

The patient also received a wireless brain-computer interface (BCI), which enables thought-driven movement when used together with the ARC-IM Stimulator.ONWARD said that its ARC-IM Stimulator is designed to deliver targeted, programmed ARC-IM Therapy to the spinal cord to restore movement and other functions after spinal cord injury.

ARC-IM Therapy has been tested across multiple clinical feasibility studies to restore mobility and stabilise blood pressure after SCI.

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ZEISS Medical Technology, Boehringer Ingelheim partner to early-detect and treat eye diseases

Under the collaboration, ZEISS Group and Boehringer Ingelheim will develop predictive analytics that facilitate early detection and prevent vision loss for people with serious eye diseases.

The two companies will leverage their expertise in ophthalmological technology, data analytics, algorithms, and treatments to detect early and treat retinal diseases before irreversible vision loss.

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Anumana’s ECG-AI LEF device gets FDA nod for low ejection fraction detection

Developed in partnership with Mayo Clinic, ECG-AI LEF is an artificial intelligence (AI)-driven software-as-a-medical device (SaMD).

Anumana designed the algorithm to screen LEF using data from a standard 12-lead electrocardiogram (ECG), which is a fast and common test that is employed in primary as well as speciality care.

The US-based health technology company, which was founded by nference in partnership with Mayo Clinic, created the algorithm using over 100,000 ECG and echocardiography data sets from patients.

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Upcoming webinars

• MedPhab: From idea to product in photonics based medical devices
• DuPont Liveo: Introducing new DuPont? Liveo? MG 7-9960 Soft Skin Adhesive

Recommended webinars

• 1Factory: Automated Quality Control for Medical Device Manufacturing
• Loftware Siemens: The challenge of labeling & UDI for medical devices

Thanks for reading; we hope you enjoyed it.

Until next week.

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