Coverage Period: August 3–16, 2026
This bi-weekly roundup covers global medical device and MedTech news announced between August 3 and August 16, 2026.
During this period, discussions surrounding the U.S. FDA's upcoming medical device user fee program, "MDUFA VI," gained momentum, alongside notable developments aimed at accelerating Medicare coverage for innovative medical devices.
In M&A, major transactions involving companies such as Integer Holdings, Varex Imaging, and VitalConnect continued to unfold. Meanwhile, in Japan, the Central Social Insurance Medical Council (Chuikyo) deliberated on the insurance reimbursement of medical devices on August 5, and the Ministry of Health, Labour and Welfare (MHLW) issued notifications regarding newly reimbursed medical devices effective August 1.
Main News
1. FDA Intensifies Discussions on Next-Generation Medical Device User Fees ("MDUFA VI")
On August 5, the FDA held a public meeting regarding the upcoming Medical Device User Fee Amendments (MDUFA VI) covering fiscal years 2028–2032.
MDUFA VI is addressing a wide range of themes, including review timelines, De Novo classification requests, Real World Evidence (RWE), digital health, international harmonization, and the Total Product Life Cycle Advisory Program (TAP).
As the current MDUFA V is set to expire at the end of September 2027, this represents a crucial regulatory overhaul that will shape the future of the U.S. medical device review system.
2. US Moves to Expedite Medicare Coverage for Breakthrough Devices
In the United States, the Centers for Medicare & Medicaid Services (CMS) is considering a new framework to better align the FDA review process with Medicare coverage pathways for devices designated as FDA Breakthrough Devices.
The aim is to shorten the timeframe for nationwide Medicare coverage following FDA approval, which could improve market access for innovative medical devices.
For medical devices, the time required not only for regulatory approval but also for securing reimbursement is a critical factor in market introduction, making future policy developments worth watching.
3. KKR to Acquire Integer Holdings for Approximately $5.7 Billion
KKR has reached an agreement to acquire Integer Holdings, a contract development and manufacturing organization (CDMO) for medical devices, for approximately $5.7 billion.
Integer develops and manufactures medical devices and components in areas such as cardiovascular and neuromodulation.
In recent MedTech M&A trends, investment is expanding not only toward finished product manufacturers but also toward CDMOs and supply chain companies that provide critical components.
4. Teledyne to Acquire Varex Imaging for Approximately $1.1 Billion
Teledyne Technologies has entered into an agreement to acquire Varex Imaging, a provider of medical X-ray technology, for approximately $1.1 billion.
Varex offers X-ray tubes, digital detectors, and other components, with its technology utilized in a wide range of diagnostic imaging systems such as CT, general radiography, and mammography.
Through this acquisition, Teledyne will further expand its business foundation in the medical imaging sector.
Source: https://www.teledyne.com/en-us/news/Pages/teledyne-to-acquire-varex-imaging-corporation.aspx
5. iRhythm Acquires VitalConnect for Approximately $288 Million
ECG monitoring giant iRhythm Technologies has announced that it will acquire wearable patient monitoring company VitalConnect for approximately $288 million.
iRhythm offers the "Zio" long-term ECG monitoring system, and by integrating VitalConnect’s wearable technology, the company will expand its patient monitoring business in out-of-hospital and home environments.
Remote patient monitoring continues to be a key investment area for MedTech companies.
6. Medtronic Expands European Rollout of Arrhythmia Treatment Devices
Medtronic is expanding its footprint in the European market for ablation technologies within the arrhythmia treatment sector.
Indications are expanding from atrial fibrillation to include ventricular arrhythmias, fueling ongoing development competition for treatment platforms that combine mapping and ablation.
Particularly in the arrhythmia treatment market centered around PFA (pulsed field ablation), competition among major players such as Medtronic, Boston Scientific, and Johnson & Johnson is intensifying.
7. FDA Updates Safety Information for Infusion, Catheter, and Respiratory-Related Products
Over the past two weeks, the FDA has updated recall and correction information for multiple medical devices, including infusion sets, catheter-related products, and breathing circuits.
The affected products include those from manufacturers such as Baxter, Hamilton Medical, and Abiomed.
For medical device manufacturers, post-market safety management and manufacturing quality control continue to be critical themes.
Source: Abiomed／Oscor： https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/catheter-introducer-correction-abiomed-and-oscor-issue-correction-catheter-introducer
Baxter Duo-Vent： https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/intravascular-administration-set-recall-baxter-removes-duo-vent-solution-sets
8. Japan: New Medical Devices Approved for Reimbursement from August 1
On July 31, the Ministry of Health, Labour and Welfare (MHLW) issued a notification regarding the new insurance reimbursement of medical devices, effective August 1, 2026.
Furthermore, "the insurance reimbursement of medical devices" was discussed as an agenda item at the General Assembly of the Central Social Insurance Medical Council (Chuikyo) held on August 5.
The insurance reimbursement of new medical devices continues to be implemented sequentially following the 2026 fiscal year medical fee revision.
Sources: https://www.mhlw.go.jp/stf/newpage_75269.html
https://kouseikyoku.mhlw.go.jp/tokaihokuriku/iryo_hoken/iryokiki/index.html
9. Japan: PMDA Updates Information on Foreign Manufacturers, Etc.
On August 6, the PMDA updated information regarding accreditation and registration numbers for foreign manufacturers.
In addition, several updates were made from early to mid-August concerning reviews, safety measures, and regulatory science-related information.
When foreign manufacturers introduce medical devices to the Japanese market, it is necessary to comply with domestic regulatory affairs procedures, including foreign manufacturer registration.
Source: https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0003.html
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Summary
In the MedTech industry from August 3 to August 16, 2026, US regulations, reimbursement systems, and major M&As were major themes.
At the FDA, discussions for the upcoming MDUFA VI have kicked into gear, with reviews being considered for the review framework for FY 2028 and beyond, encompassing RWE, digital health, and international harmonization. Additionally, momentum is building to expedite Medicare coverage for Breakthrough Devices.
In M&A, major deals followed one after another, headlined by KKR's approximately $5.7 billion acquisition of Integer Holdings, as well as Teledyne's acquisition of Varex Imaging and iRhythm's acquisition of VitalConnect.
On the safety front, the FDA updated recall and corrective action information for infusion pumps, catheters, and respiratory-related products, among others.
In Japan, new medical device reimbursement insurance coverage began on August 1, and medical device reimbursement was deliberated at the Chuikyo (Central Social Insurance Medical Council) meeting on August 5. The PMDA also updated information on foreign manufacturers, marking a two-week period during which several developments were confirmed regarding domestic regulatory affairs and insurance coverage.