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Saturday, September 5, 2026
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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 // Diagnostics & IVD

Diagnostics & IVD

Assays, point-of-care testing, sequencing and lab instruments. 7 companies listed.

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.

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.

Denver, CO  ·  Unknown  ·  PMA approved

Develops blood tests that quantify liver function from cholate clearance to stage liver disease and guide varices screening. Runs its own CLIA laboratory in Colorado.

Durham, NC  ·  Est. 2026  ·  Unknown

Building real time 3D ultrasound systems meant to replace 2D imaging for procedures such as vascular access and central line placement.

Bengaluru, India  ·  Est. 2017  ·  Unknown

Builds robotic microscopes and vision guided scanning systems for cancer diagnostics and digital pathology.

Tel Aviv, Israel  ·  Est. 2011  ·  Unknown  ·  $124M raised  ·  510(k) cleared

Built Sight OLO, a benchtop analyzer that runs a complete blood count from a small blood sample in minutes. The company laid off its remaining staff in April 2026.

Utrecht, Netherlands  ·  Est. 2017  ·  Series B  ·  De Novo granted

Builds Aletta, an autonomous robotic blood-draw device that images the vein, inserts the needle and collects the sample. CE-marked in Europe; FDA granted De Novo authorization in August 2026.

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