Andrew Celentano – Page 26 – Start Medical Product Development

Ikerian (parent company of RetinAI U.S. Inc.) receives EU-MDR Certificate for four devices, its Ophthalmology Data Platform and AI models

June 25, 2024

Bern & Boston, US, June 24th, 2024 – Ikerian AG (“Ikerian”) a leader in developing software solutions for medical image and data management and artificial intelligence (AI) in healthcare, today announced the registration as Class IIa medical devices under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR) of 4 devices.

Penumbra announces European launch of its most advanced neuro access offerings

June 25, 2024

Penumbra has announced the CE Mark and European launch of BMX81 and BMX96. These devices are designed for neurovascular management of ischemic and hemorrhagic stroke and are Penumbra’s most advanced neuro access offerings.

FDA Clears Clarius OB AI for Handheld Ultrasound: A Leap Forward in Prenatal Care

June 25, 2024

The company’s 8th AI model makes ultrasound easier for new ultrasound users to capture important fetal measurements

AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

June 25, 2024

Powered by this AI, the Pocket-Sized Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac Conditions

Novel blood-powered chip offers real-time health monitoring

June 24, 2024

Researchers at the University of Pittsburgh and University of Pittsburgh Medical Center are proposing a new device that uses blood to generate electricity and measure its conductivity, opening doors to medical care in any location.

FDA approves Endotronix Cordella PA sensor system for heart failure treatment

June 24, 2024

Endotronix today announced it received FDA premarket approval for its Cordella PA Sensor System.

Axogen launches Avive+ Soft Tissue Matrix

June 24, 2024

Axogen (Nasdaq:AXGN) today announced it has launched its Avive+ Soft Tissue Matrix.

Philips launches Duo Venous Stent System for treatment of symptomatic venous outflow obstruction

June 24, 2024

Philips, a global leader in health technology, has announced the first implant of the Duo Venous Stent System, an implantable medical device indicated to treat symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI), following premarket approval (PMA) from the U.S. Food and Drug Administration (FDA).

FDA clears orthopedics robot for TKA from Globus Medical

June 21, 2024

Globus Medical has won FDA clearance for its new ExcelsiusFlex orthopedics robot stereotaxic surgery in knee procedures and an expanded indication for its ExcelsiusHub system.

Femasys Receives CE Mark Approval for Four of its Women’s Health Products Clearing the Path for the Company to Begin Commercialization Efforts in Europe

June 20, 2024

ATLANTA, June 20, 2024 (GLOBE NEWSWIRE) — Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces it has received its European Union Medical Device Regulation (EU MDR) certificate and CE Mark certification for four of its products.

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