Connected Medical Devices Are Coming, Just Not as Fast as the Boardroom Expects
TL;DR
- Half of the 50 medtech executives Deloitte surveyed expect connected products to make up 61% to 100% of their portfolios within five years. FDA clearance data shows a much slower shift.
- Clearances describing a network or cloud connection rose from 17.3% in 2024 to 20.0% in 2025 and held near that level (19.8%) through July 2026.
- Cloud-connected clearances rose every year, from 6.2% in 2024 to 8.8% in 2026 year to date.
- Roughly two-thirds of connected clearances describe a connection without saying who is on the other end of it or why, often because a 510(k) summary isn’t written to disclose it.
- These are algorithmic classifications, not human-verified ones, so treat every figure as directional.
Half of the 50 medtech executives Deloitte surveyed in late 2024 and early 2025 predicted that connected products would make up 61% to 100% of their organization’s portfolio within five years.1 That’s a striking bet on how fast the industry is about to move, and it’s easy to see why. AI is giving connected data flows a purpose beyond a nice-to-have, from remote monitoring to decision support to fleet-wide model improvement.
“50% of surveyed medtech leaders predicted that connected care will comprise 61% to 100% of their organization’s product portfolios within the next five years.”
Deloitte Insights, Connected Care survey, 20251
Excitement about where the industry is headed is easy to come by. What’s harder is grounding a pilot budget or a leadership deck in where the industry actually is: which products are shipping today, and how fast that’s changing. So we asked a narrower, more literal version of the same question. Of the devices FDA has actually cleared, how many say anything about connectivity at all?
How We Scored 8,100 FDA Clearance Summaries
We pulled every 510(k) clearance summary FDA published from January 2024 through July 2026 (just over 8,100 records), downloaded the public summary PDF for each, and scored the extracted text for language describing a connection (Wi-Fi, Bluetooth, cellular, cloud/AWS/Azure, HL7/FHIR, DICOM, remote monitoring, and similar) versus language describing a purely local or standalone device. Full method, known gaps, and what we didn’t check are in Study Details below. Read that before citing any number here.
“Digitally connected” = network/facility or cloud tier (T3–T4, see below). Short-range pairing (Bluetooth/NFC to a phone) is tracked separately and isn’t counted here.
The Climb Is Real, and Gradual
The share of clearances describing a network or cloud connection jumped from 2024 to 2025 and held there through mid-2026, while the cloud-connected share kept rising every year. But the gains come two or three percentage points at a time. Clearances will lag R&D investment, and a portfolio’s share isn’t the same as a share of clearances, yet these trends are still markedly different from the “61–100% within five years” that medtech executives predicted. Total clearance volume itself barely moved, so the growth isn’t coming from more devices. A slightly larger share of the same volume is connected.
Share of FDA clearances describing a connection (% of classifiable 510(k) clearances, by year)
| Year | Digitally connected (T3–T4) | Cloud connected (T4) |
| 2024 | 17.3% | 6.2% |
| 2025 | 20.0% | 8.2% |
| 2026 YTD | 19.8% | 8.8% |
T1+T2 classified clearances could also be considered as connected devices. Including these would make the connected ratio closer to a quarter of device classifications describe some data connection.
Connectivity tier composition (100% of classifiable clearances, by year)
| Year | T0 · none | T1 · local/physical | T2 · short-range wireless | T3 · network/facility | T4 · cloud/remote |
| 2024 | 76.4% | 2.3% | 4.0% | 11.1% | 6.2% |
| 2025 | 73.8% | 3.1% | 3.1% | 11.8% | 8.2% |
| 2026 YTD | 73.6% | 3.0% | 3.5% | 11.0% | 8.8% |
Full clearance data
| Year | Clearances | Classifiable | Digitally connected | Cloud connected |
| 2024 | 3,129 | 2,707 (86.5%) | 468 (17.3%) | 167 (6.2%) |
| 2025 | 3,225 | 2,897 (89.8%) | 580 (20.0%) | 237 (8.2%) |
| 2026 YTD* | 1,764 | 1,527 (86.6%) | 303 (19.8%) | 135 (8.8%) |
*2026 covers Jan 1–Jul 26 only (partial year); percentages are share-of-clearances and comparable, counts are not. Classifiable excludes records where no real device text was recovered (see Study Details).
Most Summaries Are Not Saying What the Connection Is For
Among devices that do describe a connection, the most common stated purpose is reaching a provider or care team (EHR integration, PACS, a clinician dashboard, remote patient monitoring review), at 28–31% of connected clearances each year.
Stated purpose of connected clearances (% of digitally connected clearances, by year)
| Year | Digitally connected | Provider / care team | Core clinical function | Manufacturer / fleet | Patient-facing | Research / RWE | Purpose not stated |
| 2024 | 468 | 143 (30.6%) | 25 (5.3%) | 9 (1.9%) | 5 (1.1%) | 5 (1.1%) | 302 (64.5%) |
| 2025 | 580 | 162 (27.9%) | 24 (4.1%) | 15 (2.6%) | 9 (1.6%) | 10 (1.7%) | 381 (65.7%) |
| 2026 YTD* | 303 | 95 (31.4%) | 10 (3.3%) | 9 (3.0%) | 4 (1.3%) | 5 (1.7%) | 190 (62.7%) |
Percentages are share of digitally connected clearances that year (same counts as Full clearance data above). A clearance can state more than one purpose, so the stated-purpose columns can sum to more than the share with any stated purpose (34–37%); “Purpose not stated” is exclusive of the others. Purpose tags are keyword-classified and not hand-verified; several columns have fewer than 10 devices per year, so treat small differences as noise. *2026 covers Jan 1–Jul 26 only.
Core clinical functions, patient-facing apps, manufacturer fleet telemetry, and research/real-world-evidence use are each in the low single digits. But the largest single bucket, at roughly two-thirds of connected clearances, is devices that clearly describe a connection but never say who’s on the other end of it or why. That’s not necessarily a gap in the devices. It’s often just a gap in what a 510(k) summary is written to disclose.
Put together, this reads less like a contradiction of the Deloitte survey and more like confirmation of where the industry actually stands: still early. Connectivity is growing gradually, most of it doesn’t reach the cloud yet, and even where a pipe exists, what flows through it is rarely spelled out in the regulatory record. For a team deciding where to place a pilot or a proof-of-concept, that’s the opening, not the ceiling. There’s a lot of unclaimed ground between “connected” and “actually using that data for decision support.”
If your organization is trying to figure out where a connectivity pilot fits (and how to build one that produces real evidence, not just a press release), that’s a conversation StarFish has with device teams regularly. Reach out and let’s talk about what a proof-of-concept could look like for your product.
Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaboration on all our medical device development projects.
Images: Adobe Stock
Reference
1. Sheryl Jacobson, Russell Jones, Brian Doty, Carly Cook, Christine Chang, and Apoorva Singh, “Connected care is here. How can medtech help move the industry forward?,” Deloitte Insights, Deloitte Center for Health Solutions, May 27, 2025, deloitte.com/us/en/insights/industry/health-care/medtech-connected-care-innovation.html.
Study Details
Caveats, assumptions, and known gaps. Read these before citing any figure above.
Scope
510(k) clearances only, decision dates 2024-01-01 through 2026-07-26, pulled live from the openFDA API. This does not include De Novo or PMA records, which use different summary formats (De Novo decision summaries and PMA SSEDs) and were not part of this pass. Extending the analysis to 2023 and to the De Novo and PMA pathways is a planned next step.
2026 is a partial year (~7 months). Share-of-clearances percentages for 2026 are directly comparable to the full-year figures; the ~3,100/yr volume estimate is 2026’s count annualized assuming clearances land evenly across the year, which may not hold exactly.
Method
Classification is a rule-based keyword/pattern matcher run against the extracted PDF text, not an LLM judgment call. It scores weighted phrase patterns (e.g. “Bluetooth”, “AWS”, “HL7”, “cloud-hosted”), checks a window before each hit for negation (“does not contain Wi-Fi”), and assigns the highest connectivity tier that clears a minimum score, so one incidental mention can’t promote a device to “cloud connected.”
Purpose tags (P1–P5, plus P0 for “connection present, purpose unstated”) are scored only within sentences that already describe a connection, to avoid tagging boilerplate (“for use by a trained healthcare professional”) as a purpose signal.
Coverage Gaps
- No public summary was available for 93 (2024), 40 (2025), and 106 (2026 YTD) records. These were excluded from the connectivity denominator entirely, not counted as “unconnected.”
- 44 (2024) and 1 (2025) summaries were scanned images or otherwise unreadable; also excluded rather than defaulted to “no connectivity.”
- An additional 285 (2024), 287 (2025), and 131 (2026 YTD) records (about 7 to 9% each year) had no actual device description in the public PDF. Most turned out to be only the FDA clearance letter and blank Indications-for-Use form (either the filing used the abbreviated “Statement” pathway, which doesn’t require one, or the real summary wasn’t recovered). These are excluded from the denominator rather than counted as confirmed “no connectivity.”
- This dataset is U.S. FDA clearances only. It doesn’t capture devices cleared elsewhere, devices on other U.S. pathways, or connectivity added to an already-cleared device without a new submission.
Confidence
These are algorithmic classifications, not human-verified ones. Treat every percentage above as directional, not a verified measure of what the FDA documents say.
Tier definitions: T0 none · T1 local/physical (USB, removable media) · T2 short-range wireless to a paired device (Bluetooth/BLE/NFC) · T3 network/facility (Wi-Fi, Ethernet, DICOM, HL7, on-prem server) · T4 cloud/remote backend. “Digitally connected” = T3+T4 only; T2 is tracked but excluded from that figure since pairing to a phone is a materially different regulatory and data-flow story than reaching a network.
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