Globus Medical bought Synaptive Medical out of receivership in August
Globus Medical said on November 3 that it has acquired Synaptive Medical, the Ontario maker of cranial navigation, robotic digital microscopy and MRI systems. The deal closed on August 4 through an Ontario receivership, and Globus disclosed no price.
Every 510(k) clearance and original PMA approval from the last 12 months, with panel, product code and applicant, matched against the startup directory. 3,261 decisions on file, newest Oct 23, 2026.
THE FRONT
Rockwell Medical will take the majority of Vantive's hemodialysis assets, including concentrates, monitors, water treatment and the Medolla, Italy plant. Terms were not disclosed and the deal is expected to close in mid-2027.
Follow-on1nhaler raised £2.2M led by Archangels to run a first clinical trial of its cardboard dry powder inhaler. The Scottish company is targeting a regulatory filing in late 2027.
Q3 resultsONWARD Medical reported 2.5 million euros of third quarter revenue and 88 ARC-EX systems sold or supplied, up 120 percent in units. Cash was 73.4 million euros at September 30.
510(k)Contrario Medical won FDA 510(k) clearance for Cyperus, a sterile single-use sperm separation device, on November 2. The Houston company's indication covers preparing motile sperm for ICSI, IVF and IUI.
510(k)A new 510(k) adds structural heart disease patients to the VIVO indications, covering catheter ablation for monomorphic ventricular tachycardia. Catheter Precision announced the expanded US labeling on November 2.
Commercial launchConavi Medical placed its first US commercial OCTIV system at NewYork-Presbyterian/Columbia and ran its first cases there on November 2. The hybrid catheter captures IVUS and OCT images in a single pullback.
BUILD YOUR SUBMISSION
Six stages, from “does Section 524B apply” to the metrics you report after clearance, every requirement cited to FDA’s February 3, 2026 guidance.
The same gaps recur across premarket and postmarket review. Here is the deficiency language reviewers actually send, paired with what the guidance says closes each one.
PathwayThe pathway decides your evidence, your timeline and your fee. Here is how the three fit together, the FY2027 numbers, and the small business determination that cuts a 510(k) fee by three quarters.
ResourcesThe eSTAR checklist, cover letter, substantial equivalence table, predicate log, Pre-Sub package, threat model, SBOM report and the rest, in editable Word and Excel.
NOTABLE DECISIONS
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Oct 21, 26 | K261252510(k) | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | General, Plastic Surgery | SCV |
| Oct 21, 26 | K263422510(k) | Mint ACE Pump | Beta Bionics, Inc. | Clinical Chemistry | QFG |
| Oct 20, 26 | K262093510(k) | Accuro XV | Rivanna Medical, Inc. | Radiology | IYO |
| Oct 16, 26 | K260391510(k) | AVIEW Aorta Metrics | Coreline Soft Co., Ltd. | Radiology | JAK |
| Oct 16, 26 | K263234510(k) | TMINI Miniature Robotic System | THINK Surgical, Inc. | Neurology | OLO |
| Oct 16, 26 | K263266510(k) | Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | Cardiovascular | NRY |
| Oct 15, 26 | K262576510(k) | twiist Loop Algorithm | Deka Research and Development Corp. | Clinical Chemistry | QJI |
| Oct 11, 26 | K253717510(k) | Helo Return | Endovascular Engineering, Inc. | Anesthesiology | SHJ |
A working directory of medical device startups from the last five years, by category, with FDA status and funding where it is public.