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THE TAPE
Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register
The Directory // Oncology

Oncology

Tumor treatment, ablation, radiation and cancer detection devices. 11 companies listed.

San Francisco, CA  ·  Est. 2020  ·  Unknown

Makes a portable cryoablation device that lets nurses and community health workers treat precancerous cervical cells at the point of care in primary care clinics.

Cleveland, OH  ·  Growth  ·  PMA approved

Cleveland Diagnostics develops blood tests that read structural changes in cancer-related proteins. Its IsoPSA test helps urologists decide whether to biopsy men with elevated PSA.

Mountain View, CA  ·  Seed  ·  Breakthrough designation

Cordance Medical is developing a focused ultrasound system that temporarily opens the blood-brain barrier for drug delivery and liquid biopsy in brain tumors.

Brisbane, CA  ·  Est. 2014  ·  Public  ·  PMA approved

Develops blood-based cancer screening tests built on cell-free DNA methylation and machine learning. SimpleScreen CRC is its first FDA-approved product; listed on Nasdaq as FRNM in July 2026.

Redwood City, CA  ·  Est. 2015  ·  Series C  ·  $200M raised  ·  510(k) cleared

Galvanize Therapeutics builds pulsed electric field ablation systems. Aliya is cleared for soft tissue ablation and is being studied in solid tumors; RheOx targets chronic bronchitis.

Tempe, AZ  ·  Est. 2017  ·  Series D+  ·  $214M raised  ·  510(k) cleared

Sells GammaTile, a bioresorbable brachytherapy implant placed in the resection cavity during brain tumor surgery. Cleared under 510(k) with product code KXK and used at more than 150 US cancer centers.

Minneapolis, MN  ·  Growth  ·  De Novo granted

HistoSonics makes the Edison histotripsy system, which uses focused ultrasound to destroy liver tumors without incisions, heat or radiation.

Durham, NC  ·  Est. 2018  ·  Unknown

Developing a genetically encoded biomaterial that plastic and reconstructive surgeons use to regenerate fat tissue. Spun out of work by Duke professor Ashutosh Chilkoti.

Galway, Ireland  ·  Est. 2019  ·  Unknown

Builds devices that let patients manage parts of cancer treatment at home, including a wearable aimed at preventing chemotherapy hair loss.

Austin, TX  ·  Est. 2022  ·  Unknown

Handheld imaging device using frequency domain near infrared spectroscopy to indicate within a week of starting treatment whether a breast cancer therapy is working.

Toronto, ON  ·  Est. 2013  ·  Public  ·  PMA approved

Builds optical coherence tomography systems with AI detection for assessing surgical margins during cancer surgery. Listed on the TSX Venture Exchange as PINK.

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