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

New test could dramatically speed diagnosis of hard-to-detect lung infections
A little-known chronic lung disease is silently emerging as a growing public health threat in the U.S. and around the world. Nontuberculous mycobacteria—a group of 200 known environmental bacteria found in soil and water, including household plumbing—can cause chronic, tuberculosis-like lung infections. NTM lung disease afflicts as many as 300,000 Americans a year.

Osteoporosis fractures fall by 94% in small first-in-human stem cell trial
Somewhere in the world, a woman over 50 will have fractured a bone by the time you finish reading this sentence due to osteoporosis, a silent bone disease that can weaken the structural integrity of the skeletal system and a person’s quality of life. The disease weakens bones and makes them more likely to break because of reduced bone mineral density and bone mass, and it affects an estimated 75 million people across Europe, the USA, and Japan.

Piezo Direct Develops Mesh Piezo Atomizer for Inhalation Applications
Safety-driven design eliminates laser-drilling debris and holds hole diameter at 2.0 microns

Powerful Medical announces FDA De Novo nod for AI ECG
Powerful Medical today announced FDA De Novo authorization for its Queen of Hearts AI ECG model.

Beta Bionics insulin patch pump scores FDA clearance
Beta Bionics (NASDAQ: BBNX) has claimed an FDA clearance for its first patch pump insulin delivery system, amid plans to roll out an updated diabetes dosing algorithm and the launch of a new CGM partnership with Senseonics.

XCath Robotics receives FDA breakthrough nod for Iris system
XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke.

Abbott wins FDA approval for Aveir VR Mini ventricular leadless pacemaker
Abbott (NYSE: ABT) announced today that the FDA has approved the smallest version yet of its Aveir leadless pacemakers.

Retinal scans may flag atrial fibrillation four years before diagnosis
People with atrial fibrillation have signs of the condition in their retinas that can be detected as early as four years before diagnosis, according to a new study led by University College London (UCL) and Moorfields researchers.