WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

510(k)

Contrario Medical clears a single-use sperm separation device for fertility labs

MedDevice Startups Staff · 3 days ago · 2 min read · Via Contrario Medical release

Contrario Medical won 510(k) clearance for Cyperus, a sterile single-use sperm separation device, the Houston company said November 2. The indication covers preparing motile sperm from semen for ICSI, IVF and IUI in treating infertile couples.

Cyperus is a closed system with a two-membrane design that generates active flow. Contrario says the flow resembles what sperm meet in the female reproductive tract, and that it reduces microparticles, including microplastics, in the separated sample. The release cites no studies behind that claim.

Embryology and andrology lab staff run the device. Contrario says it takes fewer steps than products already on the market, and advisor Francisco Arredondo said it adds no cost to a lab's workflow.

A microparticle reduction claim is the kind a reviewer ties to a specific test method. The cleared labeling will show whether it survived review or lives only in the marketing.

Questions & Answers

What did Contrario Medical get FDA clearance for?

Contrario Medical received FDA 510(k) clearance for Cyperus, a sterile single-use sperm separation device, announced November 2, 2026. It is indicated for preparing motile sperm from semen for ICSI, IVF and IUI procedures.

How does the Contrario Medical Cyperus device work?

Cyperus is a closed, single-use system with a two-membrane design that generates active flow to separate motile sperm. Contrario Medical says the design uses fewer steps than lab products already on the market.

Where is Contrario Medical based?

Contrario Medical, Inc. is based in Houston, Texas. It develops sperm separation technology for assisted reproduction and won FDA 510(k) clearance for its Cyperus device in November 2026.

← Back to Newly Cleared