WHERE ARE YOU?
Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security
Wednesday, October 21, 2026
Updated every morning. Free. No login.
THE TAPE
Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets
The Directory // Regulatory, Quality & Testing Services

Regulatory, Quality & Testing Services

Consultancies, test labs, CROs and submission specialists that serve device startups. 2 companies listed.

InSilicoTrials
Trieste, Italy  ·  Series A  ·  Not a regulated device

Runs a cloud platform for computational modeling and in silico trials, including credibility assessment of models and FDA-ready documentation. Joined the ARPA-H CIRCLE team in September 2026 to build validation infrastructure for critical illness digital twins.

Profile →www.insilicotrials.com ↗
Scarlet
London, UK  ·  Est. 2021  ·  Series B  ·  Not a regulated device

A conformity assessment body for software and AI medical devices. It is designated as a notified body under EU MDR, an approved body for the UK MHRA, and a third party review organization recognized by FDA, and sells review and surveillance as a subscription.

Profile →
Cardiovascular Neurology & Neurotech Diagnostics & IVD Digital Health & SaMD Surgical & Robotics Orthopedics & Spine Imaging & Radiology Diabetes & Metabolic Respiratory & Sleep Wearables & Remote Monitoring Women's Health Oncology Ophthalmology & ENT Dental Rehab & Mobility Drug Delivery & Infusion GI & Urology Regulatory, Quality & Testing Services Manufacturing, Components & Supply
One email, every morning
THE MORNING BRIEF

New clearances, funding rounds and regulatory moves for device founders, and every new how-to guide and template as it lands. No noise, no login.

✓

You're in. The next morning brief lands in your inbox.

No Spam. Unsubscribe anytime.
By registering, you agree to receive communications from us. Your information may also be shared with sponsors and partners identified on this Site for relevant industry communications. You may unsubscribe at any time. See our Privacy Policy.