MedTech News
.................... by Andrew Celentano

New imaging approach simplifies retina exams by enabling digital refocusing
A team of researchers from Johns Hopkins University, Boston University, and collaborators has now demonstrated a new type of fundus camera that removes one of the main challenges: focusing. Instead of relying on mechanical adjustments of a lens, the system uses a special diffuser that captures 3D light information during imaging. With this data, a computer can reconstruct and refocus images after they are taken.

Lupin Receives U.S. FDA Approval for Risperidone Long-Acting Injectable, with 180-Day CGT Exclusivity
NAPLES, Fla., Sept. 10, 2025 /PRNewswire/ — Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials.

Abbott reports first commercial Tendyne mitral valve implant in the U.S.
An Abbott (NYSE: ABT)+
official announced on social media that doctors completed the first commercial implant of Tendyne in the U.S.

Levita Magnetics reports first AI-guided autonomous gall bladder surgery with MARS system
Levita Magnetics announced today that surgeons used its MARS platform to perform the world’s first gall bladder surgery featuring an autonomous surgical camera.

Pulse Biosciences wins FDA approval for AF study using nsPFA technology
The trial will evaluate the effectiveness of the nsPFA cardiac surgical system during concurrent surgical procedures.

Essentia Health launches new Alzheimer’s detection test
The test detects amyloid plaques, abnormal brain protein deposits linked to cognitive impairment and a key indicator of Alzheimer’s.

Neurescue gains CE mark for non-shockable cardiac arrest catheter
Neurescue’s device is claimed to be the first catheter to have received a CE mark for addressing non-shockable cardiac arrest.

Centinel Spine’s prodisc C Vivo and C Nova systems obtain MDR certification
The company has completed registration and certification for its total disc replacement products, which are now CE-marked.