Regulatory: Page 28

Varian gets FDA nod for Ethos adaptive therapy unit
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has garnered U.S. Food and Drug Administration (FDA) clearance for its Ethos system, a radiation therapy platform that utilizes artificial intelligence to adapt treatments in real-time to changes in tumors and patient anatomy.
February 10, 2020
2019 09 15 16 36 2192 Varian Ethos Show Thumb 20190916034947
U.S. House releases plan to address surprise medical billing
By AuntMinnie.com staff writers
The U.S. House of Representatives' Ways and Means Committee on February 7 released text of new legislation that would address surprise medical billing.
February 9, 2020
2017 04 20 14 33 37 718 Money Hundred Bills 400
Caption Health gets FDA nod for echo AI software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) said it has cleared artificial intelligence (AI) software developer Caption Health's Caption Guidance echocardiography AI software.
February 9, 2020
2019 10 21 17 41 6509 Artificial Intelligence Ai Suit 400
Amyloid-PET advocates take their case to Congress
By Wayne Forrest
Proponents of a bill pending in the U.S. Congress that would ensure adequate reimbursement for diagnostic radiopharmaceuticals for use with PET to diagnose Alzheimer's disease and other neurodegenerative conditions took their cause to the nation's capital on January 29.
January 29, 2020
2020 01 30 00 34 2553 2020 01 30 Amyloid Pet Thumb
NEMA releases new electrical standards, product guide
By AuntMinnie.com staff writers
The National Electrical Manufacturers Association (NEMA) has published the 2020 edition of its Electrical Standards and Products Guide.
January 28, 2020
2018 07 25 17 25 6194 Nema 400 20180928171153
FDA takes action to counter novel coronavirus
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) outlined steps it plans to take to advance the development of countermeasures against the novel coronavirus (2019-nCoV) in a statement released January 27.
January 26, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
FDA to host workshop on medical applications of AR, VR
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has scheduled for March 5 a public workshop discussing the current techniques, needs, and gaps in evaluating the use of augmented reality (AR) and virtual reality (AR) devices for medical applications.
January 22, 2020
2020 01 23 21 56 6847 Virtual Reality Glasses Surgeon 400
FDA finalizes easier rules for CADe software
By Erik L. Ridley
The U.S. Food and Drug Administration (FDA) has finalized rules that make it easier for developers of computer-aided detection (CADe) software to win regulatory clearance for their products. Certain CADe products can now be classified as class II devices.
January 20, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
Most lung vaping cases linked to informal sources of THC
By Melissa Busch
The recent outbreak of lung disease linked to vaping appears to be most prevalent in people who vaped THC-containing products obtained from informal sources, such as family, dealers, and online, according to a new report released on January 14 by the U.S. Centers for Disease Control and Prevention.
January 16, 2020
2019 08 20 18 44 6604 Vaping E Cigarette Man 400
Carestream wins FDA clearance for tomosynthesis
By AuntMinnie.com staff writers
Carestream Health has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its digital tomosynthesis software, adding a 3D capability to the firm's general radiography technology.
January 13, 2020
2020 01 14 18 18 4944 Carestream Dt 20200114183606
Aidoc secures FDA clearance for AI stroke software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Israeli artificial intelligence (AI) software developer Aidoc's AI software for identifying large-vessel occlusion stroke on head CT angiography scans.
January 12, 2020
2020 01 13 17 52 0598 Artificial Intelligence Ai Brain 400
FDA clears patient-specific 3D-printed airway stent
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared patient-specific 3D-printed airway stents designed from CT scans by a physician from the Cleveland Clinic.
January 12, 2020
2020 01 13 17 38 0908 Cleveland Clinic Stent 400 Thumb
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