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THE TAPE

FDA drafts a guided PMA submission template and sets a November 17 comment deadline FDA keeps radiology AI on the 510(k) path and denies Harrison.ai's exemption petition FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Emanate clears Perio PODS, an at-home hydrogel dressing for after scaling and root planing Wandercraft opens Eve exoskeleton sales with Medicare code K1007 in hand Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA drafts a guided PMA submission template and sets a November 17 comment deadline FDA keeps radiology AI on the 510(k) path and denies Harrison.ai's exemption petition FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Emanate clears Perio PODS, an at-home hydrogel dressing for after scaling and root planing Wandercraft opens Eve exoskeleton sales with Medicare code K1007 in hand Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027

Pre-IND

Sempresto's smartphone epinephrine injector heads for a 505(b)(2) after FDA answers 10 pre-IND questions

MedDevice Startups Staff · 3 days ago · 2 min read · Via Sempresto release

Sempresto got FDA responses to a Type B pre-IND meeting request covering 10 questions about its smartphone integrated epinephrine auto-injector. The agency answered in writing rather than holding the meeting. Sempresto said the answers were generally consistent with its development assumptions.

The product is going down the 505(b)(2) New Drug Application route, not a 510(k). An epinephrine auto-injector is a combination product whose primary mode of action is the drug, so CDER runs the review and the device constituent is assessed inside it. Founders who think of an injector as hardware usually learn that the hard way.

Sempresto is based in Weston, Massachusetts and licensed the underlying technology exclusively from Thomas Jefferson University in November 2025. CEO Elizabeth Reczek called the responses an important regulatory milestone.

Questions & Answers

What did FDA tell Sempresto about its epinephrine auto-injector?

FDA gave Sempresto written responses to 10 questions submitted with a Type B pre-IND meeting request for its smartphone integrated epinephrine auto-injector. Sempresto said on September 16, 2026 that the answers were generally consistent with its development assumptions.

What regulatory pathway is Sempresto using for its auto-injector?

Sempresto plans a 505(b)(2) New Drug Application for its smartphone integrated epinephrine auto-injector. That is the pathway for a combination product whose primary mode of action is the drug rather than the device.

Where did Sempresto's auto-injector technology come from?

Sempresto, based in Weston, Massachusetts, holds an exclusive worldwide license to the smartphone integrated epinephrine auto-injector technology from Thomas Jefferson University, signed in November 2025.

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