Medical Devices

Medical device reports

Each report covers a single newly approved device: PMA approvals, De Novo grants and Breakthrough devices with real commercial questions. We forecast installed base, procedure volume and revenue, assess reimbursement, and judge the usability and workflow risks that decide how fast clinicians adopt it. A free two page executive summary comes with every published report.

Published

Full device reports are 25 pages with internal team sharing included, written on order and delivered within 5 business days.

Free summary availableFDA PMA approvedOncologyWearable deviceOctober 2026

Optune Pax in Locally Advanced Pancreatic Cancer

Novocure's wearable Tumor Treating Fields device added about two months of survival to chemotherapy in PANOVA-3 and won FDA approval in February 2026. The report assesses why US prescriptions slowed after launch and what wear time and payer coverage mean for revenue.

Base case US 2031: ~USD 95M OS 16.2 vs 14.2 mo 266 US patients, Q3 2026
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USD 650
Order full report → Free executive summary Delivered within 5 business days
Free summary availableFDA PMA approvedCardiovascularInterventionalOctober 2026

Selution SLR in Coronary In-Stent Restenosis

Cordis' sirolimus-eluting balloon is the second coronary drug-coated balloon approved in the US, after Boston Scientific's Agent. The report sizes the in-stent restenosis opportunity, the reimbursement gap with Agent and the larger prize in small de novo vessels.

Base case US 2031: ~USD 68M Non-inferior to stents De novo trial: 960 patients
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USD 650
Order full report → Free executive summary Delivered within 5 business days
Free summary availableFDA De Novo authorizedLab automationRoboticsOctober 2026

Aletta Robotic Blood Draw in Outpatient Phlebotomy

Vitestro's Aletta is the first autonomous blood draw robot authorized by the FDA, with draw success that matches trained staff. The report models the labor economics, placement pace and workflow risks that will decide adoption in US draw centers.

Base case US 2031: ~USD 57M 95% first stick success 1 supervisor : 3 robots
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USD 650
Order full report → Free executive summary Delivered within 5 business days

Tracking a specific device?

Tell us the device, the indication and your deadline. We accept a limited number of custom device reports, using the same structure and methodology as our published reports.

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