WHERE ARE YOU?
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 // Drug Delivery & Infusion

Drug Delivery & Infusion

Pumps, injectors, inhalers and combination products. 17 companies listed.

Los Angeles, CA  ·  Est. 2016  ·  Unknown

Develops stimulus responsive materials for biomedical use. Its lead product, Humidifeye, is a thermally responsive treatment for dry eye disease.

Irvine, CA  ·  Public  ·  510(k) cleared

Makes the iLet automated insulin delivery system and the Mint patch pump, both of which dose insulin from continuous glucose monitor data.

Singapore  ·  Unknown  ·  Submission pending

Makes Bioactiv Matrix, a synthetic animal-free regenerative wound dressing produced by 3D printing. Approved by Singapore's HSA for end-use medical implants, with submissions pending in the US, EU, Australia and ASEAN.

Cambridge, MA  ·  Series B  ·  De Novo granted

Cambridge, Massachusetts spin-out from Mass General Brigham developing ReneuRx (Neural Ice), an injectable, drug-free thermal nerve block for musculoskeletal pain. FDA granted De Novo DEN250067 on August 21, 2026, creating product code SJA under 21 CFR 888.3048.

Baltimore, MD  ·  Est. 2021  ·  Series B  ·  510(k) cleared

Makes patient-specific cranial implants and is developing NeuroPASS, a skull-embedded platform for brain access, sensing and drug delivery.

New York, NY  ·  Est. 2019  ·  Unknown  ·  $11M raised  ·  510(k) cleared

Makes Perio PODS, patient-matched single-use dental trays preloaded with a hydrogel that patients wear at home after scaling and root planing.

Taipei, Taiwan  ·  Est. 2015  ·  Series B  ·  510(k) cleared

Makes the EpiFaith smart syringe, which signals the loss of resistance during epidural needle placement, and a version for central venous catheter insertion. The company says EpiFaith is in routine use at more than 30 US hospitals and pain centers.

Carlsbad, CA  ·  Seed  ·  De Novo granted

HAI Solutions makes vascular access devices aimed at healthcare-associated infections, starting with a UVC device and cap that disinfect and protect needleless IV connectors.

San Diego, CA  ·  Est. 2015  ·  Public  ·  510(k) cleared

Builds Pivot, a tubeless insulin patch pump that delivers basal and bolus insulin over a three-day wear period. Aimed at people with diabetes who have not adopted existing pumps.

Melbourne, Australia  ·  Unknown  ·  Breakthrough designation

Builds a wearable patch with DNA-based sensors on microneedles that continuously measures drug and biomarker levels. First product targets vancomycin therapeutic drug monitoring.

Zurich, Switzerland  ·  Growth  ·  $50M raised  ·  Breakthrough designation

ETH Zurich spinout behind the COMS One Therapy System, a portable non-invasive device that uses concurrent optical and magnetic stimulation to treat non-healing wounds.

Cambridge, MA  ·  Unknown  ·  In development

Develops injection platforms for high-viscosity biologics: PRIME, a needle-free jet injector, and PRIME Nexus, a reusable autoinjector. Neither is available for patient use yet.

Weston, MA  ·  Unknown  ·  In development

Developing a smartphone integrated epinephrine auto-injector under an exclusive license from Thomas Jefferson University.

Manchester, NH  ·  Unknown  ·  510(k) cleared

Sequel sells twiist, an automated insulin delivery pump that pairs with Abbott and Senseonics continuous glucose monitors and runs a dosing algorithm derived from Tidepool Loop.

Seattle, WA  ·  Est. 2012  ·  Acquired

Makes DripAssist, a low cost monitor and alarm that measures the rate of gravity fed IV fluid and blood transfusions without an infusion pump.

Westminster, CO  ·  Est. 2009  ·  Public  ·  510(k) cleared

Makes pressure-enabled infusion catheters for liver and pancreatic embolization procedures in interventional radiology. Its cleared devices include the TriNav Infusion System, TriNav Infusion System LV, TriNav Advance and a pancreatic retrograde venous infusion system.

Vancouver, BC  ·  Unknown  ·  510(k) cleared

Makes VaporShield, a closed system transfer device for subcutaneous and intramuscular injection with a retractable needle and low dead space.

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.