Watchlist
Decision calendar
Dated windows where an answer can change. Each row names the trigger, so a passing date is only material if the trigger fires.
Upcoming decision windows
| Date | Event | Scope | Trigger | Materiality |
|---|---|---|---|---|
| 30 Sep 2026 | Recheck Aetna CPB 0660 after its stated review date | United States · Mako full platform | The bulletin states a next review date of 23 July 2026, which has passed. The experimental, investigational or unproven determination on computer-assisted navigation for knee arthroplasty may or may not have survived it. | high |
| 1 Oct 2026 | FY2027 HAC Reduction Program scoring on the 2022-baseline NHSN measures. | United States · Care.ai | CMS is updating the NHSN healthcare-associated infection measures to a new 2022 baseline, which reshuffles the worst-performing quartile and therefore which hospitals carry a live 1 per cent penalty. The penalty is the purchase trigger. | medium |
| 1 Oct 2026 | FY2027 HAC Reduction Program scoring on the 2022-baseline NHSN measures. | United States · SmartHospital | CMS is updating the NHSN healthcare-associated infection measures to a new 2022 baseline, which reshuffles the worst-performing quartile and therefore which hospitals carry a live 1 per cent penalty. The penalty is the purchase trigger. | medium |
| 1 Oct 2026 | FY2027 HAC Reduction Program scoring on the 2022-baseline NHSN measures. | United States · Vocera | CMS is updating the NHSN healthcare-associated infection measures to a new 2022 baseline, which reshuffles the worst-performing quartile and therefore which hospitals carry a live 1 per cent penalty. The penalty is the purchase trigger. | medium |
| 15 Oct 2026 | Binding constraint decision, Mako Blueprint and Mako Shoulder in Australia. | Australia · Mako Blueprint / Shoulder | Confirm directly with the Department of Health, Disability and Ageing whether the Prostheses List Advisory Committee has in fact been replaced by the Medical Devices and Human Tissue Advisory Committe. | high |
| 15 Oct 2026 | Entry gate decision, Mako Blueprint and Mako Shoulder in New Zealand. | New Zealand · Mako Blueprint / Shoulder | Obtain direct confirmation from Stryker New Zealand, as WAND sponsor, of Mako Shoulder's formal Medsafe notification status, since WAND has no public search interface and this pass could not verify it. | high |
| 15 Oct 2026 | Binding constraint decision, Mako RPS in the United States. | United States · Mako RPS | Diarise the CY2027 OPPS and ASC rule and the September 2026 Cigna review; re-scan both on publication. | high |
| 30 Oct 2026 | Manual ARTG query for Mako RPS | Australia · Mako RPS | The only Australian cell in this pack that rests on search-index inference. A person must query the ARTG directly and either confirm the null or retire it. | high |
| 30 Oct 2026 | Medsafe or Stryker South Pacific WAND status check | New Zealand · Mako RPS | WAND has no public access, so the New Zealand regulatory cell cannot be closed by research at all. Only a Medsafe enquiry or an internal regulatory check resolves it. | high |
| 31 Oct 2026 | Manual ARTG query for care.ai and Vocera Sync Badge. | Australia · Care.ai | Manual ARTG query for care.ai and Vocera Sync Badge. | high |
| 31 Oct 2026 | Inpatient video psychiatry items expiry. | Australia · Care.ai | Inpatient video psychiatry items expiry. | medium |
| 31 Oct 2026 | Manual ARTG query for care.ai and Vocera Sync Badge. | Australia · Vocera | Manual ARTG query for care.ai and Vocera Sync Badge. | high |
| 31 Oct 2026 | Binding constraint decision, Mako Blueprint and Mako Shoulder in India. | India · Mako Blueprint / Shoulder | Task an India-based analyst or local counsel with obtaining the current PM-JAY Health Benefit Package shoulder arthroplasty code and rate directly from the National Health Authority, since the master. | high |
| 31 Oct 2026 | Funding route decision, Mako Blueprint and Mako Shoulder in Japan. | Japan · Mako Blueprint / Shoulder | Treat the Japanese payment question as blocked behind the regulatory one: K082 already reimburses conventional shoulder arthroplasty at 37,690 or 46,690 points, but no Mako/Blueprint-specific code can. | high |
| 31 Oct 2026 | Addressable base decision, Mako Blueprint and Mako Shoulder in Korea. | South Korea · Mako Blueprint / Shoulder | Task a Korea-based analyst to manually navigate HIRA's open-data portal, confirmed to hold 2021-2025 procedure-level statistics but only through an interactive form rather than a direct URL, to pull t. | high |
| 31 Oct 2026 | Vocera KCC type approval decision. | South Korea · Vocera | Vocera KCC type approval decision. | high |
| 31 Oct 2026 | Medsafe enquiry to establish WAND notification status. | New Zealand · Care.ai | Medsafe enquiry to establish WAND notification status. | high |
| 31 Oct 2026 | Medsafe enquiry to establish WAND notification status. | New Zealand · SmartHospital | Medsafe enquiry to establish WAND notification status. | high |
| 31 Oct 2026 | Medsafe enquiry to establish WAND notification status. | New Zealand · Vocera | Medsafe enquiry to establish WAND notification status. | high |
| 31 Oct 2026 | Device register re-query beyond the April 2026 vintage. | Singapore · Care.ai | Device register re-query beyond the April 2026 vintage. | medium |
| 31 Oct 2026 | Smart Care HSA registration check | Singapore · Mako full platform | The register vintage checked was April 2026 and showed zero entries. Re-query before any Singapore claim about Smart Care market entry. | medium |
| 31 Oct 2026 | Device register re-query beyond the April 2026 vintage. | Singapore · SmartHospital | Device register re-query beyond the April 2026 vintage. | medium |
| 31 Oct 2026 | Vocera HSA reliance filing status check. | Singapore · Vocera | Vocera HSA reliance filing status check. | high |
| 31 Oct 2026 | Device register re-query beyond the April 2026 vintage. | Singapore · Vocera | Device register re-query beyond the April 2026 vintage. | medium |
| 14 Nov 2026 | Request the falls quality and safety marker data from the commission. | New Zealand · Care.ai | Request the falls quality and safety marker data from the commission. | medium |
| 15 Nov 2026 | Knee implant price ceiling expires | India · Mako full platform | The ceiling prices on orthopaedic knee implants, extended by order S.O. 5190(E), expire on this date and no renewal decision has been published. Whether the ceiling lapses, is extended again or is restructured is genuinely unresolved, and it is the only dated Indian risk inside the engagement horizon. | high |
| 15 Nov 2026 | NPPA knee implant ceiling expiry | India · Mako RPS | The ceiling on orthopaedic knee implants runs to 15 November 2026 with no renewal decision published. Implant economics are the base on which any Indian robotic case is priced. | high |
| 15 Nov 2026 | Incumbent decision, Mako Blueprint and Mako Shoulder in Singapore. | Singapore · Mako Blueprint / Shoulder | Commission a Singapore-specific installed-base and hospital-adoption scan for Zimmer's Signature ONE shoulder planning system, which has held HSA registration (DE0505510) since 26 February 2021, rough. | high |
| 28 Nov 2026 | CDSCO classification and registration position for ambient camera AI. | India · Care.ai | CDSCO classification and registration position for ambient camera AI. | high |
| 28 Nov 2026 | Biometric Code Rule 1 assessment before any New Zealand business case. | New Zealand · Care.ai | Biometric Code Rule 1 assessment before any New Zealand business case. | high |
| 28 Nov 2026 | Biometric Code Rule 1 assessment before any New Zealand business case. | New Zealand · SmartHospital | Biometric Code Rule 1 assessment before any New Zealand business case. | high |
| 28 Nov 2026 | Biometric Code Rule 1 assessment before any New Zealand business case. | New Zealand · Vocera | Biometric Code Rule 1 assessment before any New Zealand business case. | high |
| 30 Nov 2026 | MSAC application deadline, next cycle | Australia · Mako RPS | MSAC meets about three times a year and a missed deadline costs about four months. Nothing can be filed for RPS before ARTG inclusion, so the two calendars have to be sequenced rather than run in parallel. | medium |
| 30 Nov 2026 | FY2028 fee revision, evidence window opens. | Japan · Care.ai | FY2028 fee revision, evidence window opens. | high |
| 30 Nov 2026 | FY2028 fee revision, evidence window opens | Japan · Mako full platform | Submission window for the next biennial revision. Evidence assembled from now is what the FY2028 cycle will judge. | high |
| 30 Nov 2026 | PMDA filing check for Mako RPS | Japan · Mako RPS | Everything in Japan is blocked upstream at device approval. A filing, once made, is the event that turns the whole context from blocked to live. | high |
| 30 Nov 2026 | FY2028 fee revision, evidence window opens | Japan · Mako RPS | If an approved handheld system needs the K082-8 qualifying-device definition clarified or widened, the biennial cycle is the only mechanism and FY2028 is the next one. | medium |
| 30 Nov 2026 | AI Framework Act Enforcement Decree, promulgated text. | South Korea · Care.ai | AI Framework Act Enforcement Decree, promulgated text. | high |
| 30 Nov 2026 | Robot-surgery coverage research, results expected | South Korea · Mako full platform | Internal research opened April 2026 into bringing robot-assisted surgery into cover, with results expected around November 2026. The conditions in scope are prostate cancer, invasive bladder tumour, kidney cancer and gynaecological conditions, all soft tissue. It is a watch item, not an orthopaedic coverage event, and must not be presented as one. | medium |
| 30 Nov 2026 | Direct MFDS device register read for Mako RPS | South Korea · Mako RPS | The Korean null rests on company statements rather than a register read, because the register sits behind an interactive interface or a keyed API. A keyed read would raise the finding to Singapore grade. | high |
| 30 Nov 2026 | HIRA robot-surgery coverage study results | South Korea · Mako RPS | Results expected around November 2026. The conditions in scope are all soft tissue, so this is a watch item and not an orthopaedic coverage signal. Do not overclaim it. | medium |
| 30 Nov 2026 | AI Framework Act Enforcement Decree, promulgated text. | South Korea · SmartHospital | AI Framework Act Enforcement Decree, promulgated text. | high |
| 30 Nov 2026 | AI Framework Act Enforcement Decree, promulgated text. | South Korea · Vocera | AI Framework Act Enforcement Decree, promulgated text. | high |
| 30 Nov 2026 | Singapore Medical Device Register refresh past 30 April 2026 | Singapore · Mako RPS | The zero result is measured against a register whose coverage ends on 30 April 2026, before the United States launch. Only a later snapshot can distinguish no filing from a filing that post-dates the snapshot. | high |
| 30 Nov 2026 | CY2027 OPPS/ASC rule, second tranche of the Inpatient Only phase-out | United States · Mako full platform | CMS committed to eliminating the Inpatient Only list over three years from CY2026. The CY2027 final rule, normally issued in November, sets the second tranche and with it the next step in where joint replacement cases are allowed to be done. | high |
| 10 Dec 2026 | Automated decision-making transparency obligation commences. | Australia · Care.ai | Automated decision-making transparency obligation commences. | high |
| 10 Dec 2026 | Automated decision-making transparency obligation commences. | Australia · SmartHospital | Automated decision-making transparency obligation commences. | high |
| 10 Dec 2026 | Automated decision-making transparency obligation commences. | Australia · Vocera | Automated decision-making transparency obligation commences. | high |
| 12 Dec 2026 | Indian contactless monitoring competitor re-check. | India · Care.ai | Indian contactless monitoring competitor re-check. | medium |
| 12 Dec 2026 | Indian contactless monitoring competitor re-check. | India · SmartHospital | Indian contactless monitoring competitor re-check. | medium |
| 12 Dec 2026 | Indian contactless monitoring competitor re-check. | India · Vocera | Indian contactless monitoring competitor re-check. | medium |
| 12 Dec 2026 | HSA scoping conversation on ambient camera AI. | Singapore · Care.ai | HSA scoping conversation on ambient camera AI. | high |
| 18 Dec 2026 | HSA abridged route submission decision | Singapore · Mako RPS | The abridged route is open on the United States 510(k) alone and is unused. The decision to use it or not is the single highest-leverage Singapore action for this product. | high |
| 19 Dec 2026 | Decision point: lodge or do not lodge an MSAC application | Australia · Mako full platform | MSAC and its subcommittees meet three times a year and the standard applicant-developed-assessment-report pathway runs about 13 months from application to MSAC consideration. Every quarter without a lodged application pushes any Australian robotic payment beyond 2028. | high |
| 24 Dec 2026 | Medical Service Act Article 34-2 takes effect. | South Korea · Care.ai | Medical Service Act Article 34-2 takes effect. | high |
| 24 Dec 2026 | Medical Service Act article 34-2 commencement | South Korea · Mako full platform | Korea's telemedicine legalisation takes effect, along with the regulated brokerage category in article 34-8. Portfolio-wide relevance rather than a Mako driver, but it is the market's largest dated legal change inside the horizon. | low |
| 24 Dec 2026 | Medical Service Act Article 34-2 takes effect. | South Korea · SmartHospital | Medical Service Act Article 34-2 takes effect. | high |
| 24 Dec 2026 | Medical Service Act Article 34-2 takes effect. | South Korea · Vocera | Medical Service Act Article 34-2 takes effect. | high |
| 31 Dec 2026 | AOANJRR table renumbering and CY2024 re-run check | Australia · Mako full platform | The current edition may renumber the KT66 and KT68 tables and will re-run the Triathlon CR revision comparison on newer data. No external use of the 19.2 per cent or 30.4 per cent figures is safe until they are re-checked against the current edition. | high |
| 31 Dec 2026 | Competitor CUVIS-joint supply contract delivery deadline | India · Mako full platform | Curexo disclosed a CUVIS-joint supply contract worth 5,625,000 United States dollars with an Indian distributor, for delivery by 31 December 2026. Fulfilment would extend the domestic-partnership lead on the Indian installed base. | medium |
| 31 Dec 2026 | Japan regulatory entry decision for Smart Care. | Japan · Care.ai | Japan regulatory entry decision for Smart Care. | high |
| 31 Dec 2026 | Japan regulatory entry decision for Smart Care. | Japan · SmartHospital | Japan regulatory entry decision for Smart Care. | high |
| 31 Dec 2026 | Japan regulatory entry decision for Smart Care. | Japan · Vocera | Japan regulatory entry decision for Smart Care. | high |
| 31 Dec 2026 | VUNO DeepCARS assessment concludes. | South Korea · Care.ai | VUNO DeepCARS assessment concludes. | high |
| 31 Dec 2026 | VUNO DeepCARS assessment concludes. | South Korea · SmartHospital | VUNO DeepCARS assessment concludes. | high |
| 31 Dec 2026 | VUNO DeepCARS assessment concludes. | South Korea · Vocera | VUNO DeepCARS assessment concludes. | high |
| 31 Dec 2026 | Soft Tissue Robot Assisted Surgery panel award and any scope widening | New Zealand · Mako full platform | The panel RFP closed on 12 August 2026 having excluded orthopaedic robots. Whether the award is followed by an orthopaedic round decides if a national public vehicle for Mako ever exists, or whether the public channel stays closed by design. | medium |
| 31 Dec 2026 | HIPAA Security Rule final rule, or formal withdrawal. | United States · Care.ai | The NPRM has sat unfinalised for twenty months. Whichever way it resolves, it rewrites the business-associate security obligations that gate every United States hospital IT procurement, and it is the single largest dated regulatory uncertainty for a vendor holding hospital ePHI. | high |
| 31 Dec 2026 | TEAM performance year 1 closes | United States · Mako full platform | First reconciliation of the mandatory episode model against target prices for lower extremity joint replacement at 716 participant hospitals. The first evidence of whether robot-assisted episodes cost more or less than target. | high |
| 31 Dec 2026 | HIPAA Security Rule final rule, or formal withdrawal. | United States · SmartHospital | The NPRM has sat unfinalised for twenty months. Whichever way it resolves, it rewrites the business-associate security obligations that gate every United States hospital IT procurement, and it is the single largest dated regulatory uncertainty for a vendor holding hospital ePHI. | high |
| 31 Dec 2026 | HIPAA Security Rule final rule, or formal withdrawal. | United States · Vocera | The NPRM has sat unfinalised for twenty months. Whichever way it resolves, it rewrites the business-associate security obligations that gate every United States hospital IT procurement, and it is the single largest dated regulatory uncertainty for a vendor holding hospital ePHI. | high |
| 20 Jan 2027 | Addressable base decision, Mako Blueprint and Mako Shoulder in the United States. | United States · Mako Blueprint / Shoulder | Since AAOS's Shoulder & Elbow Registry is voluntary and its captured volume grew 47% year on year between the 2024 and 2025 reports, reflecting rising participation rather than stable national volume,. | high |
| 26 Feb 2027 | Indian arthroplasty robot install census refresh | India · Mako RPS | The only published census has a September 2024 base date and projected more than 80 further installs for 2025, so the handheld ordering that defines the RPS competitive case is already out of date. | medium |
| 1 Apr 2027 | Proposed private health insurance rebate reduction for people aged 65 and over | Australia · Mako full platform | A proposed 2026 Budget measure, not enacted as at August 2026. If enacted it reduces the rebate for the age band that consumes most joint replacement, tightening the self-funded pathway that currently carries the robotic cost. | high |
| 1 Apr 2027 | Southern Cross policy revision and Affiliated Provider listing review | New Zealand · Mako full platform | Cover for robot-assisted primary hip and knee runs through a named-platform Affiliated Provider listing, and since 1 April 2026 anything not on that list is excluded outright. Continued listing is the single highest-materiality variable in the New Zealand position. The date follows the insurer's observed 1 April revision point and is an inference about cadence, not a published schedule. | high |
| 1 Apr 2027 | Southern Cross covered-platform list review | New Zealand · Mako RPS | Cover is granted by named platform and the general exclusion for unlisted robotic procedures has run since 1 April 2026. A new platform has to be added to the list by name before a single case is funded. | high |
| 30 Apr 2027 | FY2027 IPPS proposed rule. | United States · Care.ai | The annual window in which any new inpatient payment recognition for monitoring or staffing technology would first appear. Nothing has appeared to date; this is the place to watch for it. | medium |
| 30 Apr 2027 | FY2027 IPPS proposed rule. | United States · SmartHospital | The annual window in which any new inpatient payment recognition for monitoring or staffing technology would first appear. Nothing has appeared to date; this is the place to watch for it. | medium |
| 30 Apr 2027 | FY2027 IPPS proposed rule. | United States · Vocera | The annual window in which any new inpatient payment recognition for monitoring or staffing technology would first appear. Nothing has appeared to date; this is the place to watch for it. | medium |
| 13 May 2027 | Digital Personal Data Protection Rules, full compliance date. | India · Care.ai | Digital Personal Data Protection Rules, full compliance date. | high |
| 13 May 2027 | Digital Personal Data Protection Rules, full compliance date. | India · SmartHospital | Digital Personal Data Protection Rules, full compliance date. | high |
| 13 May 2027 | Digital Personal Data Protection Rules, full compliance date. | India · Vocera | Digital Personal Data Protection Rules, full compliance date. | high |
| 17 Jul 2028 | APPI 2026 amendment commencement. | Japan · Care.ai | APPI 2026 amendment commencement. | medium |
| 17 Jul 2028 | APPI 2026 amendment commencement. | Japan · SmartHospital | APPI 2026 amendment commencement. | medium |
| 17 Jul 2028 | APPI 2026 amendment commencement. | Japan · Vocera | APPI 2026 amendment commencement. | medium |