FDA-Approved Innovation

Medical Devices

Life-changing devices from implantables to wearables, transforming how we treat disease

Breakthrough Technology

Neuralink Brain-Computer Interface

Neuralink CorporationNeurotechnology

Revolutionary implantable brain-computer interface enabling paralyzed patients to control devices with thoughts. First human patient successfully playing chess and video games using only neural signals.

Electrodes

1,024 electrodes

Connectivity

Fully wireless data transmission

Battery Life

All-day battery life

Size

Coin-sized implant

Applications

  • Paralysis restoration
  • Blindness treatment
  • Mental health therapy
  • Cognitive enhancement

Clinical Status

FDA Breakthrough Device Designation

PRIME Study recruiting participants

Read Full Story

Medical Device Categories

FDA-approved devices revolutionizing treatment across specialties

Cardiac Devices

Life-saving devices for heart conditions

$71B by 2028

5.7% CAGR

Watchman FLX™

Boston ScientificLeft Atrial Appendage Closure

Stroke prevention in AFib

95% stroke risk reductionFDA Approved 2020

$25,000-30,000

HeartMate 3™

AbbottLeft Ventricular Assist Device

Advanced heart failure

2-year survival >80%FDA Approved 2018

$100,000+

Micra™ AV2

MedtronicLeadless Pacemaker

Bradycardia

93% fewer complicationsFDA Approved 2023

$15,000-20,000

Neurostimulation

Electrical stimulation for neurological conditions

$13.5B by 2027

12.4% CAGR

Percept™ PC

MedtronicDeep Brain Stimulation

Parkinson's, Essential Tremor

70% tremor reductionFDA Approved 2020

$35,000-50,000

Vercise Genus™

Boston ScientificDBS System

Dystonia, Parkinson's

Real-time neural sensingFDA Approved 2021

$40,000-60,000

Inspire

Inspire MedicalSleep Apnea Implant

Obstructive sleep apnea

79% AHI reductionFDA Approved 2014

$20,000-25,000

Continuous Glucose Monitors

Real-time glucose tracking for diabetes

$16.7B by 2030

9.8% CAGR

Dexcom G7

DexcomCGM System

Type 1 & 2 Diabetes

60% faster warmupFDA Approved 2022

$300-400/month

FreeStyle Libre 3

AbbottCGM System

Diabetes management

14-day wear, 1-minute readingsFDA Approved 2022

$70-130/month

Eversense E3

SenseonicsImplantable CGM

Long-term monitoring

6-month sensor lifeFDA Approved 2022

$99/month after insertion

Robotic Surgery

Precision surgical systems

$24B by 2029

17.5% CAGR

da Vinci 5

Intuitive SurgicalSurgical Robot

Minimally invasive surgery

10,000+ force feedback sensorsFDA Cleared 2024

$2M+ system

ROSA ONE® Brain

Zimmer BiometNeurosurgical Robot

Brain surgery assistance

0.5mm accuracyFDA Cleared 2016

$1.2M system

Mako SmartRobotics™

StrykerOrthopedic Robot

Joint replacement

Predictive modelingFDA Cleared 2017

$1M+ system

Smart Implants

Connected implantable devices

$8.2B by 2028

14.3% CAGR

Linx® Reflux System

Johnson & JohnsonAnti-reflux Device

GERD treatment

85% symptom eliminationFDA Approved 2012

$15,000-20,000

Earlens Contact Hearing

Earlens CorporationDirect Drive Hearing Aid

Hearing loss

10x frequency rangeFDA Cleared 2015

$10,000-12,000

Smart Knee Implant

Zimmer BiometSensor-enabled Knee

Total knee replacement

Real-time kinematic dataFDA Cleared 2023

$25,000-35,000

Wearable Therapeutics

Therapeutic wearable devices

$27B by 2026

25.6% CAGR

Optune Gio®

NovocureTumor Treating Fields

Glioblastoma

5-month survival benefitFDA Approved 2023

$21,000/month

VibraCool®

Pain Care LabsNeuromodulation Device

Pain management

50% pain reductionFDA Cleared 2015

$199-299

ClearUP Sinus Pain

Tivic HealthBioelectronic Device

Sinus pain relief

71% pain reductionFDA Cleared 2019

$149

Next-Generation Devices in Development

Tomorrow's medical breakthroughs in the pipeline today

Artificial Pancreas Systems

2024-2025

Automated insulin delivery

MedtronicTandemInsulet

Bioresorbable Stents

2025-2026

Dissolving cardiac stents

AbbottBoston ScientificElixir Medical

Smart Contact Lenses

2026-2027

Glucose monitoring, AR display

Mojo VisionInWithGoogle

Nano-robots

2027-2030

Targeted drug delivery

Bionaut LabsMicrobot Medical

Regulatory Milestones

Key FDA decisions shaping device innovation

2024

FDA finalizes AI/ML device guidance

Accelerated AI device approvals

2023

Breakthrough Device Program expansion

70% faster approvals for innovative devices

2022

Digital Health Pre-Cert Program

Streamlined software device pathway

2021

Remote monitoring reimbursement

Increased patient access to devices

Getting Access to Medical Devices

Resources for patients seeking advanced medical devices

Insurance Coverage

Check coverage for FDA-approved devices and appeal denials

Coverage Guide →

Clinical Trials

Access cutting-edge devices through clinical research studies

Find Trials →

Compassionate Use

Early access programs for investigational devices

Learn More →

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