Author: Andrew Celentano - Page 14 - Start Medical Product Development

Ultrasound AI Receives FDA De Novo Clearance for Delivery Date AI Technology

March 2, 2026

DENVER, March 2, 2026 /PRNewswire/ — Ultrasound AI, a pioneer in artificial intelligence applications for medical imaging, today announced it has received FDA De Novo clearance for its flagship Delivery Date AI technology, a cloud-based SaMD that determines a Predicted Delivery Date (PDD) solely from standard ultrasound images and seamless integration into current OB/MFM prenatal visit workflows; PDD is provided in real-time for actionable decision-making by the clinical team.

New record: Laser for surgery cuts bone deeper than before

March 1, 2026

Lasers cut precisely and without contact—ideal for surgery. The problem is that in hard tissues such as bone, they are too slow and do not cut deep enough. Researchers at the University of Basel have now demonstrated a way to cut much deeper and faster with a surgical laser than with previous laser systems.

Synergy Spine Solutions® Receives FDA Approval for its Synergy Disc®, Expanding Cervical Disc Replacement Options for U.S. Patients

February 27, 2026

Synergy Spine Solutions®, a medical device company focused on improving the quality of life for patients undergoing spine surgery, today announced it has received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for the Synergy Disc® for 1-level indications at C3-C7.

Engineered protein markers read living brain gene activity in monkeys via blood

February 27, 2026

Gene therapy has been successfully used to treat a number of diseases, including immune deficiencies, hereditary blindness, hemophilia and, recently, Huntington’s disease, a fatal neurological disorder.

AI accurately spots medical disorder from privacy-conscious hand images

February 27, 2026

An AI can accurately diagnose a rare endocrinological condition just by analyzing pictures of the back of the hand and the clenched fist. The privacy-conscious achievement by Kobe University holds promise for establishing more efficient referral systems and reducing health care disparities across communities.

Boehringer Wins Speedy Lung Cancer Approval Under Commissioner’s Priority Program

February 27, 2026

Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.

DeepHealth Achieves CE Mark for TechLive and Enables AWS Marketplace Deployment

February 27, 2026

TechLive is a multimodality, vendor-agnostic remote scanning and radiology management solution extending expert oversight across multiple modalities

Abbott earns FDA green light for next-gen CardioMEMS pulmonary artery pressure reader

February 27, 2026

Abbott (NYSE: ABT)+ today the FDA approved its CardioMEMS Hero next-generation pulmonary artery (PA) pressure reader.

Optellum Secures TGA Approval to Expand AI-Enabled Lung Nodule Solution To Australia

February 26, 2026

OXFORD, England, Feb. 26, 2026 /PRNewswire/ — Optellum, the leading AI-enabled solution for earlier lung cancer detection, is thrilled to announce that it has received Therapeutic Goods Administration (TGA) class IIb approval in Australia for the Virtual Nodule Clinic (VNC) platform to support early lung cancer diagnosis.

A potential immunotherapy strategy for early-stage prostate cancer

February 26, 2026

Immunotherapy has been generally ineffective for prostate cancer because the tumors are considered immunologically “cold,” meaning they do not attract enough immune cells to mount a strong attack.

Blog

- Andrew Celentano

Ultrasound AI Receives FDA De Novo Clearance for Delivery Date AI Technology

New record: Laser for surgery cuts bone deeper than before

Synergy Spine Solutions® Receives FDA Approval for its Synergy Disc®, Expanding Cervical Disc Replacement Options for U.S. Patients

Engineered protein markers read living brain gene activity in monkeys via blood

AI accurately spots medical disorder from privacy-conscious hand images

Boehringer Wins Speedy Lung Cancer Approval Under Commissioner’s Priority Program

DeepHealth Achieves CE Mark for TechLive and Enables AWS Marketplace Deployment

Abbott earns FDA green light for next-gen CardioMEMS pulmonary artery pressure reader

Optellum Secures TGA Approval to Expand AI-Enabled Lung Nodule Solution To Australia

A potential immunotherapy strategy for early-stage prostate cancer