Public web issue
Two FDA records, one SEC-hosted company report, and one narrow price observation for this week's purchase file.
Last updated: 2026-09-01
Public web issue. This edition was not sent by email. No delivery history is implied. Facts were checked against linked records through 2026-09-01.
Fast scan
Verified regulatory record
FDA recall Z-2167-2026 is open and classified; the action requires an initial inspection and recurring inspections at least every six months.
Verified regulatory record
FDA granted Abbott Diabetes Care De Novo marketing authorization for continuous ketone and glucose monitoring in people aged two years and older with diabetes.
Company-reported information
BrainsWay reported $17.1 million in second-quarter revenue, 125 systems shipped, and an approximately 1,949-system installed base.
Dated market observation
One Texas DOTmed listing remains visible at a $27,999 asking price for a seller-described 2022 unit with face and body attachments.
Source records
Safety record
Verified regulatory record
FDA recall Z-2167-2026 is open and classified. The direct record covers Selenia Dimensions mammography systems, lists 19 model numbers with all serial numbers, and reports 4,305 units in U.S. nationwide distribution.
FDA records complaints of loose, missing, or broken internal bolts over time and lists device design as the determined cause, subject to modification before termination. Hologic sent an urgent field safety notice on April 8, 2026.
The action calls for an initial inspection and recurring inspections at least every six months. It says intended use may continue, but unexpected C-arm movement requires discontinuing use and contacting Hologic Technical Support.
Before accepting a new or used system, reconcile the exact model and serial number, initial inspection, recurring schedule, torque and visual-confirmation record, other maintenance history, service eligibility, and escalation path.
An open recall record does not show that a specific unit is affected, inspected, corrected, safe, or unsafe. It does not establish failure incidence or clinical outcome. Use the live record and manufacturer instructions for the exact system.
Source: FDA recall Z-2167-2026
Page updated August 28, 2026; accessed September 1, 2026
New authorization
Verified regulatory record
FDA's August 25 release says it granted Abbott Diabetes Care De Novo marketing authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged two years and older living with diabetes.
The release says the wearable measures ketone and glucose every minute during a 10-day wear period, sends readings to a compatible smartphone, and can alert when ketones reach a concerning threshold.
FDA describes six clinical studies with more than 600 participants aged two years and older that evaluated ketone and glucose accuracy across a range of levels. It says the system tracked clinically meaningful ketone differences, including elevated levels before diabetic ketoacidosis.
A review should request the De Novo decision summary, special controls, compatible-phone list, alert configuration, patient and caregiver training, sensor supply terms, data workflow, exception handling, support, and evidence for the intended population.
The release does not provide the full study design, comparator results, subgroup performance, false-alert rates, price, reimbursement, compatibility list, support quality, or site-specific outcomes. FDA's use of first describes the authorization and is not a Device Pulse ranking.
Source: FDA Libre Duo authorization release
Released August 25, 2026; accessed September 1, 2026
Company report
Company-reported information
In an SEC-filed exhibit dated August 12, BrainsWay reported second-quarter 2026 revenue of $17.1 million and remaining performance obligations of $80.4 million as of June 30.
The company reported shipping 125 Deep TMS systems in the quarter and described an installed base of approximately 1,949 systems. It also reported $62.4 million in cash, cash equivalents, and restricted cash.
BrainsWay raised its company-reported full-year revenue guidance to $68 million to $70 million. These figures describe the company report, not the operating condition of a particular system or practice.
Use the filing to request named local service coverage, exact coil and software configuration, training, installation timing, uptime and response terms, consumables, and resale or transfer rules.
Company-reported financial and operating figures do not establish local service quality, device condition, an installed-and-operating count, utilization, clinical outcome, market share, buyer fit, or financial stability for the term of a purchase.
Source: BrainsWay Q2 2026 SEC exhibit
Dated August 12, 2026; accessed September 1, 2026
Price and ownership signal
Dated market observation
DOTmed listing 4706842 remained visible on September 1 at a $27,999 USD asking price. It describes one used/excellent 2022 InMode Morpheus8 RF Pro in Texas with face and body attachments and a seller-stated 30-day warranty.
Configuration: Seller-described 2022 Morpheus8 RF Pro with face and body attachments.
The repeat check shows listing visibility, not price discovery. Verify the exact platform and serial number, attachments, title, service history, software and consumable eligibility, transfer fees, inspection window, shipping, training, and warranty provider.
Device Pulse did not inspect the unit, contact the seller, validate the configuration or warranty, or observe a transaction. One visible ask is not a completed sale, range, median, or market price.
Source: DOTmed listing 4706842
Listing dated August 7, 2026; accessed September 1, 2026
Open research
Check the FDA record for termination, changed model scope, or revised inspection instructions before citing it again.
Open the recordRead the De Novo decision summary and special controls before building a product comparison.
Open the recordKeep company scale separate from local support evidence and verify service terms in a current buyer document.
Open the recordBuyer move of the week
For every system, list each manufacturer-required inspection, its interval, the responsible service party, the evidence produced, the downtime trigger, and what happens after transfer. Make delivery acceptance conditional on the current records and a written next-service date.
A device can arrive operational while still missing the inspection history, component checks, or service eligibility needed to keep it in use.
Research shortcut
Use the TMS category to map exact systems, coils, software, training, service, and transfer questions before contacting a seller.
Open TMS researchSend this page to the person who reviews clinical evidence, the person who owns the capital budget, and the person who will manage service calls. Keep the direct source links with the interpretation. A forwarded summary without the identifier, date, configuration, or limitation loses the part that makes it useful.
If a colleague owns an affected unit or has an active quote, ask them to open the live record. FDA recall status and manufacturer instructions can change after an archive date. A company release can be replaced by a later filing. A marketplace listing can change or disappear without proving that a unit sold.
Use the public archive for prior issues, the Buyer’s Guide for device research, the research methodology for evidence rules, and the visible correction section when a material record changes. Signup is optional. This web edition was not sent by email.
No. This is a public web issue. No subscriber list was accessed or contacted.
No. Match the exact model and serial number to the live FDA record, inspection evidence, and manufacturer instructions.
No. The release describes a De Novo authorization and supporting program, not comparative superiority or fit for a particular workflow.
No. Company-reported scale does not establish service coverage, response time, uptime, or support quality in a buyer's territory.
No. It is one seller-controlled asking price for one visible listing. No completed sale was observed.
There are none. Results stay unpublished until real responses meet the documented minimum sample and methodology requirements.
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