What's actually shipping

Earflo won Best of Innovation in Digital Health. Home device for treating the middle ear in kids. Clinical study: 86% hearing improvement, prevented surgery in 90% of children. Company filed for 510(k) before applying for the award.

Bond Ring - FDA-cleared smart ring. ECG, blood pressure, continuous temperature monitoring. Clinical measurements covered by insurance, not wellness tracking.

VitalTracker measures heart rate, respiratory rate, SpO2, and blood pressure through computer vision. Point camera at the face - AI extracts vitals without contact. Positioning for remote patient monitoring.

AgeTech pavilion

AARP's AgeTech Collaborative at Venetian Expo, Hall A-D, Booth 54123. Pavilion is about 12,800 sq ft with 22-24 startups.

What they're showing:

• Diligent Robotics - Moxi, humanoid robot supporting nurses, already working in 25+ US hospitals

• HoustonBionics - ExoRehab X, home robotic exoskeleton for arm rehabilitation after stroke

• Toi Labs - TrueLoo, smart toilet seat with AI analysis of stool and urine for early detection of GI issues

• Wellvii - BP Go, compact cuffless blood pressure monitor

• Cadense - shoes with Variable Friction Technology (MIT background) for people with balance issues

Medicare started paying for home monitoring in 2018 through CPT codes 99453, 99454, 99457, 99458. Basic coverage: device setup, monthly payment for data transmission (minimum 16 days out of 30), clinical management (20+ minutes per month). Works for chronic conditions: cardiovascular, diabetes, COPD, heart failure.

AI and FDA

Almost every device at CES claims AI-powered insights. The issue is that if your AI model updates and changes behavior, you need a predetermined change control plan documenting how the model can evolve within validated boundaries.

Johnson & Johnson got Monarch cleared with Nvidia integration by defining what exactly can change and what stays locked.

The schedule shows the shift

Abbott, Dexcom, Oura running sessions on continuous monitoring and clinical integration. Samsung Health presenting Xealth acquisition and provider partnerships. Oracle showing EHR connectivity for wearable data.

Five years ago health track at CES was fitness apps and step counters. Now it's four days of sessions on reimbursement strategy, RPM programs, clinical validation.

Money moved in December

Mega-rounds over $100M jumped 70% year-over-year:

• Impulse Dynamics - $158M for cardiac contractility modulation (implant for heart failure)

• Neuralink - $650M for brain-computer interface

• HistoSonics - $250M for non-invasive histotripsy platform

• Kardium - $250M for multi-electrode atrial fibrillation treatment system

• CMR Surgical - $200M for Versius robotic surgical system

• SetPoint Medical - $140M for bioelectronic neuromodulation implants

• Apreo Health - $130M for interventional emphysema treatment

Investors pay for complex hardware with data layers and regulatory pathways.

JP Morgan next week

CES ends January 9th. JP Morgan Healthcare Conference January 12-15 in San Francisco.

If you're in SF that week:

RESI Conference runs January 12-13 at Marriott Marquis - 700+ active investors, pre-seed to Series B focus.

BIO Partnering January 12-15, same location, for 1:1 investor meetings.

Biotech Dealmaking: Regulatory Considerations January 12, 11:30 AM-2:30 PM (includes lunch).

Berkeley Bio Startup Showcase January 13, 4:00-6:00 PM.

CES is where you demo the device.
JP Morgan is where you discuss the business model and get funded.

Grants closing in January

January 15: NIAAA SBIR/STTR for addiction and alcohol-related devices

January 6: EU4Health orphan medical devices — €1M-18M for pediatric and rare disease devices

Blueprint MedTech is open for neuromodulation and nervous system devices with IDE/PMA pathways.

NIH policy changed in 2025: simplified review framework, limit of 6 applications/year per PI, and multi-year funding that squeezed the budget for new awards. National Cancer Institute funding ~4% of applications instead of previous 9%. "Middle class" applications with good but not top-5% scores are getting cut even on resubmit.

FDA made eSTAR mandatory

As of October 2025, De Novo submissions require an electronic format through eSTAR. Specific file structures, naming conventions, and version control from day one.

Supply chain

Component lead times hit 52 weeks this quarter for some medical-grade sensors. Devices at CES either designed around component availability 18 months ago or sitting in delays.

December recalls

FDA recall list December 2025: ventilators, patient lifts, cardiovascular support devices, contact lenses.

2025 recall data: life-support and high-dependency devices. Manufacturing process flaws and unreliable supplier components. Not random bad luck — systematic problems baked in from the start.

Discovery costs $12K-18K. Recall costs $2M+ plus credibility with FDA and hospitals.

If you're building hardware and want my team to handle engineering while you focus on business - 👇👇👇👇👇

Lisa