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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 // Wearables & Remote Monitoring

Wearables & Remote Monitoring

Patches, wearables, home monitoring and hospital-at-home hardware. 41 companies listed.

London, UK  ·  Unknown  ·  510(k) cleared

Makes AcuPebble, a wearable acoustic sensor worn on the neck that records breathing and heart sounds at home to diagnose sleep apnea.

Singapore  ·  Seed  ·  510(k) cleared

Singapore company behind AeviceMD, a wearable stethoscope for remote respiratory monitoring, plus a cleared software module that flags suspected wheeze in recorded lung sounds.

Besançon, France  ·  Est. 2018  ·  Series A  ·  $9M Series A in 2026, after €5.5M in 2022 raised  ·  510(k) cleared

Makes EOlife, a real-time ventilation feedback device that measures the air volume delivered to a cardiac arrest patient's lungs and shows rescuers when to adjust.

Atlanta, GA  ·  Est. 2022  ·  Unknown  ·  In development

Developing Maternal aRMOR, a wrist worn monitor that uses laser and camera sensing of red blood cell flow to detect postpartum hemorrhage. Won the MedTech Innovator 2025 grand prize.

Petah Tikva, Israel  ·  Series B  ·  510(k) cleared

Biobeat makes a chest-worn patch that measures blood pressure and other vitals without a cuff, cleared for 24-hour ambulatory monitoring.

San Diego, CA  ·  Series C  ·  510(k) cleared

Makes Biolinq Shine, a needle-free forearm patch whose microsensor array reads glucose from the top layers of skin. A color-coded LED on the patch shows the glucose range without a phone, and the device also logs activity and sleep.

Seattle, WA  ·  Est. 2021  ·  Unknown  ·  510(k) cleared

Makes Intellidrop, an automated external CSF drainage system that measures intracranial pressure continuously and drains to a set pressure or volume target in the ICU.

Chicago, IL  ·  Series A  ·  De Novo granted

Builds a chest-worn cardiac sensor and AI software that noninvasively estimate hemodynamic pressures for heart failure management.

London, UK  ·  Series A  ·  $102.5M raised  ·  Submission pending

CoMind is developing CoMind One, a non-invasive optical monitor for cerebral blood flow, autoregulation and intracranial pressure in critical care.

Bothell, WA  ·  Seed  ·  $8M+ raised  ·  In development

Remote robotic ultrasound platform that lets a sonographer run a diagnostic imaging exam on a patient in another location.

Salt Lake City, UT  ·  Series B  ·  $46M raised  ·  510(k) cleared

Makes REMI, a wireless wearable EEG system with disposable sensors that records brain activity for up to 30 days in hospitals and at home, with AI event detection for clinician review.

Modiin, Israel  ·  Series B  ·  $20M Series B first close announced September 2026 raised  ·  CE mark

Builds FIZE kUO, a digital urine output monitor for fluid management in intensive care, plus a predictive platform called FIZE Optima in development.

Austin, TX  ·  Series A  ·  $75M raised  ·  510(k) cleared

The Happy Ring is a sensor ring cleared to diagnose obstructive sleep apnea at home. The company is building a home care platform around it.

Santa Clara, CA  ·  Est. 2015  ·  Public  ·  510(k) cleared

Makes a credit card sized ECG recorder that captures cardiac signals along three non-coplanar axes and synthesizes a 12-lead ECG from them.

Toronto, ON, Canada  ·  Unknown

Makes HeartWatch, a wearable for continuous at home heart monitoring with an emergency contact function.

Neuchatel, Switzerland  ·  Est. 2018  ·  Series B  ·  $119M raised  ·  510(k) cleared

Builds a cuffless blood pressure wearable that estimates pressure from optical signals at the wrist, calibrated by a connected upper-arm cuff. Sold as a membership with a band, an app and the cuff.

Paris, France  ·  Est. 2016  ·  Growth  ·  $63M raised  ·  510(k) cleared

Remote monitoring platform that pulls data from cardiac implants made by different manufacturers into one system and flags the patients who need attention. Two of its algorithms are FDA-cleared Class II software.

Seed  ·  Not a regulated device

Makes the Orbiter, a powered wheelchair cushion with five independently controlled zones that shifts pressure across the seat to reduce pressure injury risk.

Boston, MA  ·  Est. 2024  ·  Seed  ·  $12M raised

Builds hearing assistance into eyeglass frames, sold over the counter. Founded by engineers from Bose and Apple.

Irvine, CA  ·  Est. 2018  ·  Unknown

Makes a wireless patch for continuous breathing monitoring, first aimed at patient safety during procedural sedation.

Minneapolis, MN  ·  Unknown  ·  510(k) cleared

Remote prenatal and postpartum monitoring. The M•care System uses the M•wrap wearable and abdominal electrodes to capture fetal and maternal heart rate at home and send it to clinicians.

Paris, France  ·  Seed  ·  510(k) cleared

Builds an earbud-based EEG system that records single-channel brain activity at home and sends it to clinicians. Cleared in the US in January 2026.

Cork, Ireland  ·  Est. 2024  ·  Seed  ·  2.1 million euros raised  ·  Submission pending

Builds a pocket-sized wireless brain monitor that detects seizures in newborns at the NICU bedside. Spun out of University College Cork in January 2024.

Pleasanton, CA  ·  Acquired  ·  De Novo granted

Makes Nidra, a pair of wearable units that stimulate the peroneal nerves to reduce symptoms of moderate to severe restless legs syndrome in adults whose medication has stopped working. Resmed acquired the company in June 2026.

Unknown  ·  In development

Develops plasma and urine proteomic panels for early disease detection, and is building a wearable patch that tracks inflammation after a heart attack.

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.

Bedford, PA  ·  Pre-seed  ·  In development

Combines physiologic sensor data with electronic health record data to predict and prevent hospital-acquired pressure injuries.

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.

South Portland, ME  ·  Unknown  ·  De Novo granted

Makes the Prapela SVS bassinet pad, which delivers randomized vibration to treat neonatal opioid withdrawal syndrome. Technology licensed from Harvard's Wyss Institute.

Omer, Israel  ·  Est. 2014  ·  Public  ·  De Novo granted

Pulsenmore makes a smartphone cradle that lets pregnant women perform ultrasound scans at home for remote reading by clinicians. It is listed on the Tel Aviv Stock Exchange.

Houston, TX  ·  Pre-seed  ·  In development

Makes PulmVac, a wearable chest drainage device for pneumothorax with real-time pressure monitoring.

Shenzhen, China  ·  Est. 2021  ·  Unknown  ·  510(k) cleared

Consumer smart ring that tracks sleep, activity, stress and recovery, with FDA-cleared non-invasive blood oxygen measurement added in October 2026.

Mountain View, CA  ·  Unknown  ·  In development

Builds Sylvee, a wearable chest sensor that uses acoustic resonance to measure trapped air and lung volumes at home for people with COPD. Won MedTech Innovator in 2024.

London, UK  ·  Est. 2019  ·  Series B  ·  $68M raised  ·  In development

Developing a wearable microsensor that continuously measures molecules just beneath the skin, starting with glucose. Its filament is roughly a tenth the length of a conventional CGM's.

San Marcos, TX  ·  Est. 2016  ·  Series A  ·  510(k) cleared

Makes the Halo Vital Signs Monitor, a wearable that tracks pulse oximetry, heart rate, respiratory rate, temperature and posture for clinical, emergency and field use.

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.

Dehradun, India  ·  Est. 2016  ·  Series A  ·  $7M Series A in 2026 raised  ·  Submission pending

Builds the Spandan line of smartphone-connected ECG devices for personal, clinical and institutional cardiac screening, with remote physician review.

Irvine, CA  ·  Est. 2019  ·  Unknown

Makes a wearable sticker that measures blood pressure continuously, using a nanosensor developed at UC Irvine. Founded by Ray Liu, Michelle Khine and Josh Kim.

New Haven, CT  ·  Series B  ·  $10M Series B first tranche raised  ·  510(k) cleared

Runs the Spire remote patient monitoring system with wearable Health Tags for continuous cardiopulmonary tracking, aimed at catching COPD deterioration before symptoms appear.

Seoul, South Korea  ·  Est. 2019  ·  Unknown  ·  510(k) cleared

Samsung SDS spinoff selling the S-Patch wearable ECG monitors and cloud analysis software, including the S-Patch CardioAI arrhythmia analysis software licensed to monitoring providers and testing facilities.

San Francisco, CA  ·  Est. 2019  ·  Unknown

Makes a wearable headband that uses EEG sensors and machine learning to detect a stroke as it starts and alert emergency services.

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