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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets
The Directory // 326 companies · 19 categories

Find a Startup

Medical device startups from the last five years, by category. FDA status comes from the clearance tracker where an applicant matches; funding figures are public numbers only.

BY CATEGORY

19 CATEGORIES

Structural heart, electrophysiology, vascular access and cardiac monitoring.

All 85 →

Assays, point-of-care testing, sequencing and lab instruments.

All 44 →

Software as a medical device, AI decision support and digital therapeutics.

All 51 →

Ultrasound, MRI, CT, optical imaging and image analysis.

All 49 →

CGM, insulin delivery and metabolic monitoring.

All 8 →

Ventilation, sleep apnea, airway and pulmonary devices.

All 19 →

Patches, wearables, home monitoring and hospital-at-home hardware.

All 41 →

Fertility, maternal health, pelvic and breast health devices.

All 15 →

Tumor treatment, ablation, radiation and cancer detection devices.

All 33 →

Dental implants, aligners, imaging and chairside tools.

All 3 →

Exoskeletons, prosthetics, physical therapy and assistive devices.

All 9 →

Endoscopy, incontinence, kidney and gastrointestinal devices.

All 29 →

Consultancies, test labs, CROs and submission specialists that serve device startups.

All 2 →

RECENTLY ADDED

8 NEWEST
Boca Raton, FL  ·  Unknown  ·  Submission pending

Builds robotically assisted radiation therapy systems for brachytherapy and intraoperative radiation therapy. Its Vektra platform follows Sculptura, a beam-sculpting system Empyrean bought from Sensus Healthcare in 2022.

Menlo Park, CA  ·  Est. 2023  ·  Unknown  ·  510(k) cleared

Builds airway and GI stents, cryo biopsy probes and steerable endobronchial instruments, plus molecular diagnostics for lung cancer triage. Formed under Ajax Health in 2023 and acquired Thoracent in 2025.

Kaunas, Lithuania  ·  Unknown  ·  CE mark

Robotic platform for remote endovascular procedures, pairing a bedside unit that drives guidewires and catheters with a radiation-free control suite. Also sells Inflante, a digitally controlled indeflator for balloon inflation.

San Francisco, CA  ·  Series D+  ·  $150M raised  ·  510(k) cleared

Cloud-native radiology platform that combines PACS, diagnostic viewing, reporting and worklist in a single system. Also sells Sirona Cortex, an agentic AI layer for radiology workflow.

Besançon, France  ·  Est. 2018  ·  Series A  ·  $9M Series A in 2026, after €5.5M in 2022 raised  ·  510(k) cleared

Makes EOlife, a real-time ventilation feedback device that measures the air volume delivered to a cardiac arrest patient's lungs and shows rescuers when to adjust.

Suzhou, China  ·  Series B  ·  Not a regulated device

Develops ophthalmic imaging hardware and AI diagnostic software, including the MIAS-3000 OCT analysis system cleared as a Class III device in China.

Bristol, United Kingdom  ·  Est. 2020  ·  Seed  ·  £470K equity plus an £8.4M Innovate UK contract raised  ·  In development

Builds handheld optical coherence tomography systems on a photonic chip, for retinal disease monitoring in clinics and at home.

Dehradun, India  ·  Est. 2016  ·  Series A  ·  $7M Series A in 2026 raised  ·  Submission pending

Builds the Spandan line of smartphone-connected ECG devices for personal, clinical and institutional cardiac screening, with remote physician review.

STARTUP NEWS

8 STORIES
01
510(k) Filed

Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system

Empyrean Medical Systems filed a 510(k) for Vektra, a robotically assisted brachytherapy and intraoperative radiation therapy system. Vektra builds on Sculptura, cleared in 2019 and bought from Sensus Healthcare for $15M in cash.

Empyrean Medical Systems2 days ago2 min
02
Partnership

Paradromics hands Siemens Healthineers the imaging workup for its brain implant

Paradromics will work with Siemens Healthineers on imaging protocols for its Connexus brain-computer interface, covering candidacy assessment through surgical navigation. Neither company disclosed financial terms.

MassDevice2 days ago2 min
03
Guidelines

Neuromod says Lenire is named in the first AAO-HNSF tinnitus guideline update since 2014

AAO-HNSF published an updated tinnitus clinical practice guideline on October 12 with a new statement on bimodal neuromodulation. Neuromod Devices said October 16 that its De Novo authorized Lenire device is named in it.

PR Newswire5 days ago2 min
04
Hire

EndoQuest hires a commercial chief before filing its De Novo

EndoQuest Robotics named former HCA Healthcare robotics VP Jared Eben chief commercial officer on October 15. The Houston company is preparing a De Novo request for its endoluminal surgical robot and targets a US launch next year.

MedTech Dive6 days ago2 min
05
IPO withdrawn

BioVentrix withdraws its $17M Nasdaq IPO eight months after filing

BioVentrix pulled the registration for a roughly $17 million Nasdaq listing it filed in February 2026. The company said the terms of the offering were never set and no securities were sold.

MassDevice6 days ago2 min
06
Market exit

Siemens Healthineers stops selling its general ultrasound carts

Siemens Healthineers has stopped selling Acuson general ultrasound carts, including the Sequoia, Redwood, Juniper and Maple. It will keep the Freestyle point-of-care probes and the Acuson Origin cardiovascular line.

MassDeviceOct 132 min
07
Distribution

Zimmer Biomet extends its exclusive deal for a Persona version of Think Surgical's TMINI

Zimmer Biomet extended its exclusive distribution agreement with Think Surgical for a multi-year term, announced October 13. Zimmer sells a version of the TMINI handheld robot configured for its Persona knee system.

MedTech DiveOct 132 min
08
Litigation

Boston Scientific sues J&J's Atraverse over a patent issued in September

Boston Scientific sued Atraverse Medical in Delaware over US Patent 12,733,955, which issued September 15, 2026. The accused product is Hotwire, an RF transseptal guidewire cleared in May 2024. Johnson & Johnson bought Atraverse earlier this year.

MD+DIOct 92 min

Listing is editorial and does not imply endorsement. Companies are added from FDA filings, funding announcements, accelerator cohorts and reader tips. To add or correct a listing, send it in.

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