https://www.nsmedicaldevices.com/news/indica-labs-secures-fda-nod-for-halo-ap-dx-digital-pathology-platform/
Indica Labs secures FDA nod for HALO AP Dx digital pathology platform
May 9, 2024 - Indica Labs has secured the US Food and Drug Administration (FDA) 510(k) clearance for its enterprise digital pathology platform, HALO AP Dx.
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https://www.bioworld.com/articles/726320-bayers-her2-mutated-lung-cancer-treatment-gets-fda-nod?v=preview
Bayer’s HER2-mutated lung cancer treatment gets FDA nod | BioWorld
A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S....
mutated lung cancerfda nod
https://www.statesman.com/business/technology/article/austin-brain-implant-paradromics-clinical-trials-21205266.php
Austin-based Paradromics wins FDA nod for brain-implant trials
Nov 25, 2025 - The Austin-based neurotechnology company announced that it has received approvals to start its clinical trials.
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https://www.medtechdive.com/news/Boston-Scientific-fda-approval-Agent-drug-coated-coronary-balloon/709053/
Boston Scientific gains FDA nod for drug-coated coronary balloon | MedTech Dive
BTIG analyst Marie Thibault said physicians could rapidly adopt the first-of-its-kind device.
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https://www.bioworld.com/articles/727576-stereotaxis-magic-magnetic-ablation-gets-fda-nod?v=preview
Stereotaxis’ Magic magnetic ablation gets FDA nod | BioWorld
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https://www.drugdeliverybusiness.com/tandem-wins-fda-nod-to-pair-mobi-pump-with-android-smartphones/
Tandem wins FDA nod to pair Mobi pump with Android phones
Nov 10, 2025 - Tandem Diabetes Care announced today that it received FDA approval for the Android version of its Mobi mobile app.
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https://www.statnews.com/2024/12/19/spinal-cord-injury-onward-medical-arc-ex-fda-approval/
Onward Medical spinal cord stimulator gets FDA nod | STAT
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https://www.bioworld.com/articles/723580-fda-gives-nod-to-respiree-wearable-for-home-care?v=preview
FDA gives nod to Respiree wearable for home care | BioWorld
The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory...
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https://www.medicaldevice-network.com/news/a2z-radiology-ai-ct-device/
a2z Radiology AI gets FDA nod for abdomen-pelvis CT device
Nov 28, 2025 - a2z Radiology AI has secured approval from the FDA for its a2z-Unified-Triage, a triage system for abdomen-pelvis CT scans.
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https://www.drugdeliverybusiness.com/dexcom-fda-cgm-basal-dosing-t2d/
Dexcom wins FDA nod for CGM-integrated basal dosing for type 2
Nov 19, 2025 - Dexcom announced today that the FDA cleared its Smart Basal CGM-integrated basal insulin dosing optimizer.
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https://www.ibtimes.co.uk/sam-altman-backed-arcadia-medicine-gets-fda-nod-trials-healthier-ecstasy-formula-1747609
Sam Altman-Backed Arcadia Medicine Gets FDA Nod for Trials on 'Healthier' Ecstasy Formula | IBTimes...
Oct 13, 2025 - San Francisco biotech Arcadia Medicine, backed by Sam Altman, wins FDA nod to trial AM-1002, a safer MDMA variant to treat anxiety.
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