$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 |
|---|---|---|---|---|---|
| Aug 8, 2026 | M Medtronic, Inc. General Hospital |
General Hospital | PMA Supplement | SynchroMed Infusion System; Ascenda Intrathecal Catheters — Approved (30-day notice) | P860004/S459 |
| Aug 8, 2026 | M Medtronic Neuromodulation Gastroenterology, Urology |
Other | PMA Supplement | InterStim Therapy System, Verify Evaluation System — Approved (30-day notice) | P970004/S455 |
| Aug 8, 2026 | M Medtronic Neuromodulation Neurology |
Neurology | PMA Supplement | Master Restore; Itrel; Synergy; Intellis … — Approved (30-day notice) | P840001/S630 |
| Aug 8, 2026 | M Medtronic, Inc. Neurology |
Neurology | PMA Supplement | Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense — Approved (30-day notice) | P960009/S540 |
| Aug 7, 2026 | R Roen Surgical, Inc. Gastroenterology, Urology |
Other | 510(k) | Zamenix P — Cleared | K253505 |
| Aug 7, 2026 | I Intuitive Surgical, Inc. Gastroenterology, Urology |
Other | 510(k) | Intuitive Endoluminal Gastrointestinal System (IG1000) — Cleared | K253702 |
| Aug 7, 2026 | L Lakong Medical Devices Co., Ltd. Dental |
Dental | 510(k) | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) — Cleared | K251544 |
| Aug 7, 2026 | B Bumlicious, LLC (DBA Bumlicious) Obstetrics/Gynecology |
Women's Health | 510(k) | BUM Oil — Cleared | K261905 |
| Aug 7, 2026 | M Mediaire GmbH Radiology |
Imaging | 510(k) | mdprostate — Cleared | K252571 |
| Aug 7, 2026 | T The Surgical Company International B.V., doing business as TSC Life Cardiovascular |
Cardiovascular | 510(k) | Mistral-Air® Warming System — Cleared | K261437 |
| Aug 7, 2026 | P Philips Medical Systems Nederland B.V. Radiology |
Imaging | 510(k) | Zenition 30 — Cleared | K254205 |
| Aug 7, 2026 | A Aptitude Medical Systems, Inc. Microbiology |
Diagnostics | 510(k) | Metrix COVID Test; Metrix COVID Test Pro — Cleared | K253453 |
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 |
|---|---|---|---|---|---|---|---|
M Medtronic, Inc. |
SynchroMed Infusion System; Ascenda Intrathecal Catheters | General Hospital | PMA Supplement | Approved (30-day notice) | P860004/S459 | Aug 8, 2026 | 29d |
M Medtronic Neuromodulation |
InterStim Therapy System, Verify Evaluation System | Other | PMA Supplement | Approved (30-day notice) | P970004/S455 | Aug 8, 2026 | 29d |
M Medtronic Neuromodulation |
Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and … | Neurology | PMA Supplement | Approved (30-day notice) | P840001/S630 | Aug 8, 2026 | 29d |
M Medtronic, Inc. |
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense | Neurology | PMA Supplement | Approved (30-day notice) | P960009/S540 | Aug 8, 2026 | 29d |
R Roen Surgical, Inc. |
Zamenix P | Other | 510(k) | Cleared | K253505 | Aug 7, 2026 | 280d |
I Intuitive Surgical, Inc. |
Intuitive Endoluminal Gastrointestinal System (IG1000) | Other | 510(k) | Cleared | K253702 | Aug 7, 2026 | 256d |
L Lakong Medical Devices Co., Ltd. |
Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Dental | 510(k) | Cleared | K251544 | Aug 7, 2026 | 444d |
B Bumlicious, LLC (DBA Bumlicious) |
BUM Oil | Women's Health | 510(k) | Cleared | K261905 | Aug 7, 2026 | 60d |
M Mediaire GmbH |
mdprostate | Imaging | 510(k) | Cleared | K252571 | Aug 7, 2026 | 358d |
T The Surgical Company International B.V., doing business as TSC Life |
Mistral-Air® Warming System | Cardiovascular | 510(k) | Cleared | K261437 | Aug 7, 2026 | 99d |
P Philips Medical Systems Nederland B.V. |
Zenition 30 | Imaging | 510(k) | Cleared | K254205 | Aug 7, 2026 | 221d |
A Aptitude Medical Systems, Inc. |
Metrix COVID Test; Metrix COVID Test Pro | Diagnostics | 510(k) | Cleared | K253453 | Aug 7, 2026 | 305d |
C Cepheid |
Xpert Hemorrhagic Fever | Diagnostics | 510(k) | Cleared | K261362 | Aug 7, 2026 | 102d |
L Leica Biosystems Imaging, Inc. |
Aperio GT 450 DX; Aperio GT 180 DX | Diagnostics | 510(k) | Cleared | K253554 | Aug 7, 2026 | 266d |
Y Yadu Medical (Henan) Co., Ltd. |
Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Surgical | 510(k) | Cleared | K261028 | Aug 7, 2026 | 130d |
L Leica Biosystems Imaging, Inc. |
Aperio iQC DX Software | Diagnostics | 510(k) | Cleared | K253561 | Aug 7, 2026 | 263d |
H Hangzhou Qiantang Longyue Biotechnology Co., Ltd. |
Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R … | General Hospital | 510(k) | Cleared | K260933 | Aug 7, 2026 | 140d |
S Shenzhen Chuangtong Yigou Technology Co., Ltd. |
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Surgical | 510(k) | Cleared | K261601 | Aug 7, 2026 | 85d |
T The Belport Company Inc., DBA Gingi-Pak |
PacTemp Automix NE | Dental | 510(k) | Cleared | K261937 | Aug 7, 2026 | 58d |
A Arthrex, Inc. |
Arthrex Bioabsorbable PushLock Suture Anchors | Orthopedic | 510(k) | Cleared | K262357 | Aug 7, 2026 | 28d |
G GE Medical Systems Ultrasound and Primary care Diagnostics, LLC |
Venue Go | Imaging | 510(k) | Cleared | K261668 | Aug 7, 2026 | 79d |
M Maxx Orthopedics, Inc. |
Freedom Total Knee System (E-Poly Tibial Liners) | Orthopedic | 510(k) | Cleared | K261563 | Aug 7, 2026 | 88d |
F Fujifilm Corporation |
EW10-EC02 Endoscopy Support Program | Other | 510(k) | Cleared | K260567 | Aug 7, 2026 | 169d |
B Biotronik AG |
ORSIRO Sirolimus Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved | P170030/S065 | Aug 7, 2026 | 28d |
T Tiger Aesthetics Medical, LLC |
Sanae® | Surgical | PMA Supplement | Approved | P020012/S051 | Aug 7, 2026 | 143d |
A Abbott Medical |
Tendyne Transcatheter Mitral Valve System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240042/S003 | Aug 7, 2026 | 22d |
B Boston Scientific Corporation |
Axonics Sacral Neuromodulation System | Other | PMA Supplement | Approved | P180046/S113 | Aug 7, 2026 | 56d |
G Guardant Health, Inc. |
Guardant360® CDx | Diagnostics | PMA Supplement | Approved | P200010/S032 | Aug 7, 2026 | 28d |
B Baxter Healthcare Corporation |
PerClot® Polysaccharide Hemostatic System | Surgical | PMA Supplement | Approved | P210036/S008 | Aug 7, 2026 | 161d |
I Irvine Biomedical, Inc. |
Ampere Generator | Cardiovascular | PMA Supplement | Approved | P040014/S051 | Aug 7, 2026 | 88d |
B Baxter Healthcare Corporation |
PerClot® Polysaccharide Hemostatic System | Surgical | PMA Supplement | Approved | P210036/S009 | Aug 7, 2026 | 151d |
S St Jude Medical |
TactiSys Quartz Equipment; Ampere Generator | Cardiovascular | PMA Supplement | Approved | P130026/S102 | Aug 7, 2026 | 88d |
S St Jude Medical |
Ampere Generator | Cardiovascular | PMA Supplement | Approved | P960016/S094 | Aug 7, 2026 | 88d |
A Abbott Medical |
Ampere Generator | Cardiovascular | PMA Supplement | Approved | P110016/S095 | Aug 7, 2026 | 88d |
I Irvine Biomedical,Inc.(Ibi) |
Ampere Generator | Cardiovascular | PMA Supplement | Approved | P040042/S059 | Aug 7, 2026 | 88d |
A Abbott Medical |
TactiSys Quartz Equipment; Ampere Generator | Cardiovascular | PMA Supplement | Approved | P220013/S033 | Aug 7, 2026 | 88d |
B Boston Scientific Corporation |
Axonics Sacral Neuromodulation System | Other | PMA Supplement | Approved | P190006/S113 | Aug 7, 2026 | 56d |
I Irvine Biomedical, Inc. |
Ampere Generator | Cardiovascular | PMA Supplement | Approved | P060019/S059 | Aug 7, 2026 | 88d |
O Organox Limited |
OrganOx metra System | Other | PMA Supplement | Approved (30-day notice) | P200035/S041 | Aug 7, 2026 | 22d |
N Nobel Biocare AB |
Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC … | Dental | 510(k) | Cleared | K253999 | Aug 6, 2026 | 234d |
O Overjet, Inc. |
Overjet Multi-Image Caries and Charting Assist | Imaging | 510(k) | Cleared | K261059 | Aug 6, 2026 | 128d |
P Paragon 28, Inc. |
Megalodon Dynamic Compression System | Orthopedic | 510(k) | Cleared | K261121 | Aug 6, 2026 | 125d |
S Scientia Vascular, Inc. |
Aristotle Mini Guidewire | Cardiovascular | 510(k) | Cleared | K260223 | Aug 6, 2026 | 192d |
E Edan Instruments, Inc. |
Telemetry Monitor (iT30, iT50) | Cardiovascular | 510(k) | Cleared | K251508 | Aug 6, 2026 | 447d |
J Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
Manual Wheelchair (H008, PCK7) | Physical Medicine | 510(k) | Cleared | K261571 | Aug 6, 2026 | 86d |
M Mozarc Medical Us, LLC |
Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) … | Other | 510(k) | Cleared | K253469 | Aug 6, 2026 | 300d |
H Howmedica Osteonics Corp. dba Stryker Orthopaedics |
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Orthopedic | 510(k) | Cleared | K261898 | Aug 6, 2026 | 62d |
Q QIAGEN GmbH |
QIAstat-Dx BCID GPF Plus AMR Panel | Diagnostics | 510(k) | Cleared | K254194 | Aug 6, 2026 | 226d |
C Carl Zeiss Meditec Production, LLC |
Ct Lucia 602; Ct Lucia 202; Ct Lucia 611P; Ct Lucia 621P | Ophthalmic | PMA Supplement | Approved (30-day notice) | P100016/S026 | Aug 6, 2026 | 17d |
B Boston Scientific Corp |
Epic Vascular Self-Expanding Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P110035/S078 | Aug 6, 2026 | 24d |
M Medinol, Ltd. |
EluNIR Ridaforolimus Eluting Coronary Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P170008/S064 | Aug 6, 2026 | 29d |
P Physio-Control, Inc. |
LIFEPAK® 35 monitor/defibrillator | Cardiovascular | PMA Supplement | Approved | P160026/S071 | Aug 6, 2026 | 7d |
B Boston Scientific Corp |
Eluvia Drug-Eluting Vascular Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P180011/S069 | Aug 6, 2026 | 24d |
M Medtronic, Inc. |
Sphere-9 Catheter AFR-00001 | Cardiovascular | PMA Supplement | Approved (30-day notice) | P240013/S030 | Aug 6, 2026 | 22d |
B Boston Scientific Corporation |
Innova Self Expanding Stent System | Cardiovascular | PMA Supplement | Approved (30-day notice) | P140028/S087 | Aug 6, 2026 | 24d |
F Farapulse, Inc. |
FARAPULSE Pulsed Field Ablation System | Cardiovascular | PMA Supplement | Approved | P230030/S018 | Aug 6, 2026 | 176d |
M Medtronic Cryocath, LP |
Stop AF First | Cardiovascular | PMA Supplement | Approved | P100010/S152 | Aug 6, 2026 | 359d |
X Xiamen Inno Medical Technology Co., Ltd. |
CAD - Lower GI (EC07-01) | Other | 510(k) | Cleared | K252853 | Aug 5, 2026 | 331d |
T Tianjin Huahong Technology Co., Ltd. |
Huahong Sharps Container (HHR-I, HHR-II) | General Hospital | 510(k) | Cleared | K260845 | Aug 5, 2026 | 142d |
C Class Medical , Ltd. |
Transurethral Catheter Safety Valve (TUCSV) (80050) | Other | 510(k) | Cleared | K260919 | Aug 5, 2026 | 139d |
Source: U.S. FDA via openFDA. 1701 decisions dated Apr 26, 2026 – Aug 24, 2026. Every row links to its FDA record. Last refreshed 2026-08-24 08:00. FDA publishes decided submissions only; pending reviews are not public data.