Andrew Celentano – Page 34 – Start Medical Product Development

Meditrina Announces CE Mark Approval and First Multi-International Cases Performed

May 14, 2024

SAN JOSE, Calif., May 13, 2024 /PRNewswire/ — Meditrina, a leading innovator in gynecologic medical devices, announces the successful receipt of UKCA Mark, and CE Mark approval in accordance with Regulation (EU) 20147/745, for its state-of-the-art Aveta Hysteroscopy System. With this significant milestone achieved, Meditrina is thrilled to enter international markets, marking a pivotal moment in the company’s commitment to advancing women’s health globally.

Rapid Medical™ Completes Successful Ischemic Stroke Procedures with the World’s First Robotic Thrombectomy Device

May 14, 2024

The procedures utilized an AI-powered, robotic TIGERTRIEVER to automate and optimize personalized treatments

OrthAlign Launches Lantern® Handheld Technology for Total, Partial, and Revision Knee Arthroplasty in Japan.

May 14, 2024

IRVINE, Calif., May 14, 2024 /PRNewswire/ — OrthAlign, Inc., a leading innovator in surgical technology, announces the launch of its flagship product, Lantern, in Japan. The launch will be driven by its longstanding commercial partner, who have represented OrthAlign in the market since 2013 and supported over 68,000 OrthAlign cases.

Boston Micro Fabrication Launches ‘industry first’ hybrid micro-precision 3D printer series

May 14, 2024

The microArch D1025 Dual-Resolution 3D printer delivers the additive manufacture of parts that require micron-level precision and repeatability, with potential uses in the healthcare and life sciences fields.

Profound Medical wins FDA clearance for AI to support prostate cancer procedure

May 14, 2024

Profound Medical (Nasdaq:PROF) announced today that it received FDA 510(k) clearance for its second AI model for treating prostate cancer.

FDA warns not to use Cue Health COVID-19 test kits

May 14, 2024

The FDA has warned that home test users, caregivers and healthcare providers should not use Cue Health COVID-19 diagnostics.

Carthera wins U.S., EU orphan drug designation for SonoCloud

May 14, 2024

Carthera announced today that it received FDA and European orphan drug designation (ODD) for the use of carboplatin with its SonoCloud.

Olympus Announces Launch of Bronchoscopes Compatible with EVIS X1™ Endoscopy System

May 13, 2024

CENTER VALLEY, Pa., May 13, 2024 /PRNewswire/ — Olympus, a global medical technology company, announced today the launch of two bronchoscopes as part of the EVIS X1 Endoscopy System. The EVIS X1 Endoscopy System represents the latest in diagnostic and therapeutic bronchoscopy from Olympus.

Medtronic pulsed field ablation system wins approval in Japan

May 10, 2024

Medtronic (NYSE: MDT)+
announced today that its PulseSelect pulsed field ablation (PFA) system has won regulatory approval in Japan.

FDA Clears the Individualized Nomogram for Rika Plasma Donation System

May 9, 2024

LAKEWOOD, Colo., May 9, 2024 /PRNewswire/ — Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rika Plasma Donation System™ with the iNomi™ Nomogram. This innovation means that plasma collection volume can be determined by an individual donor’s height, weight and hematocrit level on the day they donate plasma.

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