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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 // Cybersecurity

Cybersecurity

Product security, SBOM, pentesting and vulnerability management for device makers. 10 companies listed.

Sunnyvale, CA  ·  Unknown

Provides asset discovery and risk management for IoMT, IoT and OT devices, including vulnerability prioritization, device patching and segmentation orchestration. Founded by Shankar Somasundaram, who previously ran IoT security at Symantec.

Scottsdale, AZ  ·  Est. 2014  ·  Bootstrapped

Consultancy that handles premarket cybersecurity for device makers: penetration testing of hardware, firmware, apps and cloud, plus threat modeling, SBOMs and the documentation that goes into 510(k), De Novo and PMA submissions. Founded by Christian Espinosa.

Boston, MA  ·  Unknown

Runs a risk management network that health systems use to assess vendors, products and medical devices, covering third-party, enterprise and AI governance risk. The vendor catalog covers tens of thousands of products, so device makers are assessed through it.

New York, NY  ·  Est. 2017  ·  Unknown

Runs a platform that inventories connected medical and IoT devices on hospital networks, then tracks their vulnerabilities, flags threats and supports network segmentation. Customers include RWJBarnabas Health and several NHS trusts.

Columbus, OH  ·  Est. 2017  ·  Unknown

Analyzes device firmware and binaries to generate SBOMs and find vulnerabilities, and automates the security evidence manufacturers file for FDA and other regulators. Serves medical device, automotive, energy and industrial makers.

Solana Beach, CA  ·  Est. 2016  ·  Series B  ·  $36.4M raised

Sells software and services that medical device manufacturers use to handle product security: SBOM and vulnerability management through Helm, encryption and key management through Guardian, plus threat modeling and premarket submission support.

Fort Lauderdale, FL  ·  Unknown

Provides device cybersecurity services across the product lifecycle: threat modeling, penetration testing, SBOMs, vulnerability scanning and postmarket plans for regulatory submissions. In March 2026 it launched BRIDGE, a platform for passing security advisories from manufacturers to hospitals. Led by CEO Michelle Jump.

Unknown

Sells embedded runtime protection and observability for connected devices, using integrity verification built into device firmware rather than a network agent. Medtronic is a named customer.

Richmond, TX  ·  Est. 2012  ·  Unknown

Contract design and manufacturing firm for active therapeutic and diagnostic devices whose services include embedded cybersecurity, secure firmware development and automated test systems. Known for helping scale ventilator production with General Motors in 2020.

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