$1.4B
Surgical Robotics Funding 2026
↑ 61% YoY · Fastest growing category
$890M
Cardiovascular Device Deals
↑ 34% YoY · Structural heart leading
$620M
Neuromodulation Investment
↑ 48% YoY · Closed-loop driving growth
$540M
Diabetes Device Rounds
↑ 22% YoY · CGM + closed-loop
2026 Funding by Device Category
Surgical Robotics$1.40B
Cardiovascular Devices$890M
Neuromodulation$620M
Diabetes / Metabolic$540M
Imaging / Diagnostics HW$480M
Orthopedics / Spine$310M
Wearables / RPM$260M
Device Deal Flow (2026 Monthly)
JANFEBMARAPRMAYJUNJULAUGSEPOCTNOVDEC
52
Deals YTD
$1.9B
Deployed YTD
$36M
Avg Deal Size
Top Strategic Acquirers / Investors
6 deals · Surgical robotics focus
8 deals · Cardiac + neuro
11 deals · Device-focused VC
7 deals · Late-stage devices
Medtronic Ventures
5 deals · Strategic investments
Recent Device Activity
Most recent FDA device clearances, approvals and De Novo grants
| Decision Date | Company | Category | Pathway | Device & Outcome | FDA ID |
|---|---|---|---|---|---|
| Oct 11, 2026 | E Endovascular Engineering, Inc. Anesthesiology |
Anesthesiology | 510(k) | Helo Return — Cleared | K253717 |
| Oct 9, 2026 | N Nexus CMF, LLC Orthopedic |
Orthopedic | 510(k) | TruVision Single-Use 1.9mm Arthroscopy System — Cleared | K260156 |
| Oct 9, 2026 | S Shenzhen Jianchao Intelligent Technology Co., Ltd. General, Plastic Surgery |
Surgical | 510(k) | IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820 … — Cleared | K262352 |
| Oct 9, 2026 | C CathRx, Ltd. Cardiovascular |
Cardiovascular | 510(k) | Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) — Cleared | K262068 |
| Oct 9, 2026 | F Fertilis Pty, Ltd. Obstetrics/Gynecology |
Women's Health | 510(k) | Fertilis microICSI Device — Cleared | K262090 |
| Oct 9, 2026 | I Ischemaview, Inc. Radiology |
Imaging | 510(k) | Rapid ICH (v4.0) — Cleared | K262301 |
| Oct 9, 2026 | S Shenzhen Jianchao Intelligent Technology Co., Ltd. Physical Medicine |
Physical Medicine | 510(k) | Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524 … — Cleared | K262834 |
| Oct 9, 2026 | V Vivachek Biotech (Hangzhou) Co., Ltd. Clinical Chemistry |
Diagnostics | 510(k) | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System … — Cleared | K260687 |
| Oct 9, 2026 | N Neurotronics, LLC Neurology |
Neurology | 510(k) | Sleep Analysis Module — Cleared | K261521 |
| Oct 9, 2026 | S Stryker Neurovascular Cardiovascular |
Cardiovascular | 510(k) | Excelsior Reach Microcatheter — Cleared | K261649 |
| Oct 9, 2026 | W Wishbone SA Dental |
Dental | 510(k) | Wishbone HAE — Cleared | K260096 |
| Oct 9, 2026 | C CarboFix Orhtopedics , Ltd. Neurology |
Neurology | 510(k) | CarboClear® Cervical Navigated Instruments — Cleared | K263154 |
Most recent FDA device decisions. Source: openFDA.
Regulatory Pipeline Tracker
510(k) clearances, PMA approvals and De Novo grants, sourced from the U.S. FDA
| Company | Device | Category | Pathway | Decision | FDA ID | Decision Date | Review |
|---|---|---|---|---|---|---|---|
E Endovascular Engineering, Inc. |
Helo Return | Anesthesiology | 510(k) | Cleared | K253717 | Oct 11, 2026 | 321d |
N Nexus CMF, LLC |
TruVision Single-Use 1.9mm Arthroscopy System | Orthopedic | 510(k) | Cleared | K260156 | Oct 9, 2026 | 262d |
S Shenzhen Jianchao Intelligent Technology Co., Ltd. |
IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) | Surgical | 510(k) | Cleared | K262352 | Oct 9, 2026 | 91d |
C CathRx, Ltd. |
Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) | Cardiovascular | 510(k) | Cleared | K262068 | Oct 9, 2026 | 109d |
F Fertilis Pty, Ltd. |
Fertilis microICSI Device | Women's Health | 510(k) | Cleared | K262090 | Oct 9, 2026 | 109d |
I Ischemaview, Inc. |
Rapid ICH (v4.0) | Imaging | 510(k) | Cleared | K262301 | Oct 9, 2026 | 94d |
S Shenzhen Jianchao Intelligent Technology Co., Ltd. |
Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620 … | Physical Medicine | 510(k) | Cleared | K262834 | Oct 9, 2026 | 59d |
V Vivachek Biotech (Hangzhou) Co., Ltd. |
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System … | Diagnostics | 510(k) | Cleared | K260687 | Oct 9, 2026 | 220d |
N Neurotronics, LLC |
Sleep Analysis Module | Neurology | 510(k) | Cleared | K261521 | Oct 9, 2026 | 155d |
S Stryker Neurovascular |
Excelsior Reach Microcatheter | Cardiovascular | 510(k) | Cleared | K261649 | Oct 9, 2026 | 143d |
W Wishbone SA |
Wishbone HAE | Dental | 510(k) | Cleared | K260096 | Oct 9, 2026 | 269d |
C CarboFix Orhtopedics , Ltd. |
CarboClear® Cervical Navigated Instruments | Neurology | 510(k) | Cleared | K263154 | Oct 9, 2026 | 30d |
M Materialise NV |
CMF Titanium Splints | Dental | 510(k) | Cleared | K260913 | Oct 9, 2026 | 204d |
M Medical Components, Inc. |
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler | General Hospital | 510(k) | Cleared | K260080 | Oct 9, 2026 | 270d |
F Fujifilm Corporation |
ECHELON Synergy | Imaging | 510(k) | Cleared | K262902 | Oct 9, 2026 | 52d |
A Allwin Medical Devices, Inc. |
The D-Tip Denudation Pipette | Women's Health | 510(k) | Cleared | K261234 | Oct 9, 2026 | 177d |
M Med-El Corp. |
MED-EL Cochlear Implant System | Other | PMA Supplement | Approved | P000025/S136 | Oct 9, 2026 | 491d |
M Medtronic Neuromodulation |
InterStim Therapy System, Verify Evaluation System | Other | PMA Supplement | Approved (30-day notice) | P970004/S459 | Oct 9, 2026 | 29d |
M Medtronic Neuromodulation |
InterStim Therapy System, Verify Evaluation System | Other | PMA Supplement | Approved (30-day notice) | P080025/S353 | Oct 9, 2026 | 29d |
M Medtronic, Inc. |
Affera Sphere-9 Mapping and Ablation Catheter | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240013/S032 | Oct 9, 2026 | 28d |
O Organox Limited |
OrganOx metra® System | Other | PMA Supplement | Approved | P200035/S038 | Oct 9, 2026 | 168d |
B Biotronik, Inc. |
Acticor Sky HF-T 481986; Rivacor Sky HF-T 481991; Rivacor Rise HF-T 482017; Rivacor Aura HF-T 482013 … | Cardiovascular | PMA Supplement | Approved | P050023/S213 | Oct 9, 2026 | 88d |
B Biotronik, Inc. |
Edora 8 HF-T QP 407137; Edora 8 HF-T 407138; Evity 8 HF-T QP 407139; Evity 8 HF-T 407140 … | Cardiovascular | PMA Supplement | Approved | P070008/S181 | Oct 9, 2026 | 88d |
D Depuy, Inc. |
ATTUNE Revision Knee System | Orthopedic | PMA Supplement | Approved (30-day notice) | P830055/S379 | Oct 9, 2026 | 10d |
B Biotronik, Inc. |
Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evity 6 DR-T 407149 … | Cardiovascular | PMA Supplement | Approved | P950037/S296 | Oct 9, 2026 | 88d |
A Abbott Medical |
Motorized Outer Tubing Cutter for UltiPace Leads | Cardiovascular | PMA Supplement | Approved (30-day notice) | P960013/S135 | Oct 9, 2026 | 29d |
B Biotronik, Inc. |
Acticor Sky VR-T 481989; Rivacor Sky VR-T 481984; Rivacor Rise VR-T 482020; Rivacor Aura VR-T 482015 … | Cardiovascular | PMA Supplement | Approved | P980023/S149 | Oct 9, 2026 | 88d |
B Biotronik, Inc. |
Acticor Sky DR-T 481987; Rivacor Sky DR-T 481982; Rivacor Rise DR-T 482018; Rivacor Aura DR-T 482014 | Cardiovascular | PMA Supplement | Approved | P000009/S132 | Oct 9, 2026 | 88d |
D Dent4You AG |
One Coat Bond; One Coat Bond SL | Dental | 510(k) | Cleared | K263680 | Oct 8, 2026 | 1d |
S Stryker Instruments |
Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000) … | Other | 510(k) | Cleared | K262244 | Oct 8, 2026 | 99d |
S Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp) … | Imaging | 510(k) | Cleared | K261617 | Oct 8, 2026 | 146d |
S Samsung Medison Co., Ltd. |
V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System … | Imaging | 510(k) | Cleared | K263150 | Oct 8, 2026 | 30d |
W Wuhan Phomed Technology Co., Ltd. |
CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30) … | Surgical | 510(k) | Cleared | K262346 | Oct 8, 2026 | 90d |
I IVT Medical, Ltd. |
MeCare Alpha (MCA2019) | Surgical | 510(k) | Cleared | K260426 | Oct 8, 2026 | 240d |
N Neuroxt, Inc. |
NEXT-Cue | Neurology | 510(k) | Cleared | K261805 | Oct 8, 2026 | 129d |
V Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
VENTANA MMR RxDx Panel | Diagnostics | PMA Supplement | Approved | P210001/S016 | Oct 8, 2026 | 300d |
V Vistakon, Division of Johnson & Johnson Vision Car |
VISTAKON (SENOFILCON A) Brand Contact Lenses | Ophthalmic | PMA Supplement | Approved (30-day notice) | P040045/S146 | Oct 8, 2026 | 20d |
W W. L. Gore & Associates, Inc. |
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | Cardiovascular | PMA Supplement | Approved | P160021/S051 | Oct 8, 2026 | 244d |
C Croma-Pharma GmbH |
saypha® ChiQ | Surgical | PMA Supplement | Approved | P250021/S002 | Oct 8, 2026 | 90d |
A Abbott Medical |
Volt PFA Catheter, Sensor Enabled | Cardiovascular | PMA Supplement | Approved (30-day notice) | P250022/S009 | Oct 8, 2026 | 24d |
V Ventana Medical Systems |
VENTANA MMR RxDx Panel | Diagnostics | PMA Supplement | Approved | P200019/S014 | Oct 8, 2026 | 300d |
A Abbott Medical |
Volt Pfa Catheter, Sensor Enabled | Cardiovascular | PMA Supplement | Approved (30-day notice) | P250022/S012 | Oct 8, 2026 | 10d |
D Depuy, Inc. |
ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System … | Orthopedic | PMA Supplement | Approved (30-day notice) | P830055/S377 | Oct 8, 2026 | 24d |
Z Zhongshan GL Electronics Co. , Ltd. |
Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) | Surgical | 510(k) | Cleared | K262822 | Oct 7, 2026 | 58d |
D Deep Reasoning Ai, Inc. |
NeuroDR | Imaging | 510(k) | Cleared | K262134 | Oct 7, 2026 | 104d |
C Centers for Disease Control and Prevention |
B. anthracis Real-time PCR Assay | Diagnostics | 510(k) | Cleared | K262368 | Oct 7, 2026 | 89d |
C Centinel Spine, LLC |
prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments | Orthopedic | 510(k) | Cleared | K263159 | Oct 7, 2026 | 28d |
U UAB Ligence |
Ligence Heart | Imaging | 510(k) | Cleared | K261733 | Oct 7, 2026 | 134d |
C Ceiba Healthcare US, Inc. |
eClinics | Cardiovascular | 510(k) | Cleared | K260075 | Oct 7, 2026 | 268d |
I InnoDtech, Inc. |
Dr.AlignNavi | Dental | 510(k) | Cleared | K262378 | Oct 7, 2026 | 86d |
B Beijing Nubway S&T Co., Ltd. |
Diode Laser Hair Removal Machine (QDTM-03) | Surgical | 510(k) | Cleared | K261692 | Oct 7, 2026 | 138d |
V Vista AI, Inc. |
Vista AI Scan | Imaging | 510(k) | Cleared | K260092 | Oct 7, 2026 | 268d |
P Paragon 28, Inc. |
APEX 3D S Diamond Tibia | Orthopedic | 510(k) | Cleared | K261120 | Oct 7, 2026 | 187d |
J JenaValve Technology, Inc. |
Trilogy Transcatheter Heart Valve System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P250024/S006 | Oct 7, 2026 | 9d |
C Croma-Pharma GmbH |
saypha® ChiQ | Surgical | PMA Supplement | Approved | P250021/S001 | Oct 7, 2026 | 89d |
O Okami Medical, Inc. |
LOBO Vascular Occlusion System | Cardiovascular | 510(k) | Cleared | K262798 | Oct 6, 2026 | 60d |
U Urolution Medical, Inc. |
OpenFlo Urinary Catheter | Other | 510(k) | Cleared | K261141 | Oct 6, 2026 | 182d |
B Bayer Medical Care, Inc. |
MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12) … | Cardiovascular | 510(k) | Cleared | K262043 | Oct 6, 2026 | 111d |
A Anhui JBH Medical Apparatus Co., Ltd. |
Power Wheelchair (DC12) | Physical Medicine | 510(k) | Cleared | K261079 | Oct 6, 2026 | 188d |
A Alembic, LLC |
APRO 88 Catheter | Cardiovascular | 510(k) | Cleared | K261938 | Oct 6, 2026 | 118d |
Source: U.S. FDA via openFDA. 1591 decisions dated Jun 28, 2026 – Oct 26, 2026. Every row links to its FDA record. Last refreshed 2026-10-26 08:00. FDA publishes decided submissions only; pending reviews are not public data.