WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

Label update

FDA adds kidney disease and diabetes data to the Symplicity Spyral label

MedDevice Startups Staff · 2 days ago · 2 min read · Via Medtronic

FDA approved updated labeling for Medtronic's Symplicity Spyral renal denervation system. The label now carries clinical data for patients with isolated systolic hypertension, chronic kidney disease through stage 3b, and type 2 diabetes. The indication for use did not change.

The update landed with primary endpoint data from SPYRAL AFFIRM, the post approval study FDA required. At six months, office systolic pressure fell 18.2 mmHg, home pressure fell 9.4 mmHg and 24 hour ambulatory pressure fell 9.7 mmHg, each at p below 0.0001. Antihypertensive medication count held at 3.6. The composite safety endpoint hit 2.1 percent of patients.

Labeling that names comorbid populations without touching the indication is the quiet form of expansion. It gives physicians and payers data to point at for the patients they actually see, and it is a concrete answer to what a mandated post approval study can buy a sponsor back.

Questions & Answers

What did FDA add to the Medtronic Symplicity Spyral label?

The updated Symplicity Spyral labeling, announced November 3, 2026, adds clinical data for patients with isolated systolic hypertension, chronic kidney disease through stage 3b, and type 2 diabetes. Medtronic says the indication for use is unchanged.

What were the six month results of Medtronic's SPYRAL AFFIRM study?

In SPYRAL AFFIRM, office systolic blood pressure fell 18.2 mmHg at six months, home blood pressure fell 9.4 mmHg and 24 hour ambulatory blood pressure fell 9.7 mmHg, each at p below 0.0001. The composite safety endpoint occurred in 2.1 percent of patients.

Where were the SPYRAL AFFIRM results presented and published?

Medtronic presented SPYRAL AFFIRM as late breaking data at TCT 2026 and published the results in Circulation: Cardiovascular Interventions on November 3, 2026.

← Back to Regulatory