FDA Approval of Colorectal Cancer Blood Test, Major Investment in AF Treatment, and Medical Device Recalls in Japan
From July 27 to August 2, 2026, the global medical device and MedTech industry saw significant developments across a wide range of fields, including cancer diagnostics, cardiovascular, medical robotics, M&A, and safety measures.
In the United States, Freenome's colorectal cancer blood test received FDA approval, with commercialization planned by Abbott. Additionally, a major funding round led by Medtronic was conducted in the atrial fibrillation (AF) treatment sector.
In Japan, the PMDA published information on multiple medical device recalls, and clinical trial information conducted from a humanitarian perspective was also updated.
1. Freenome Obtains FDA Approval for Colorectal Cancer Blood Test
Freenome has obtained FDA approval for its blood test intended for colorectal cancer screening.
This test, which can be performed with only a blood draw, is expected to be a new option in addition to fecal occult blood tests and colonoscopies. Abbott will handle sales, and the product is scheduled to be launched in the US in the fall of 2026.
Source
- Reuters
2. Medtronic Invests $37 Million in CoreMap
CoreMap, a company developing high-precision mapping technology for atrial fibrillation (AF), has raised $37 million in a Series C funding round.
The funding round was led by Medtronic and will accelerate the development of CoreMap's mapping system, which aims to improve ablation precision in complex AF cases.
Source
- MedTech Dive
3. Abbott Initiates Large-Scale Post-Market Study for TriClip
Abbott has initiated a post-market study involving approximately 1,000 patients for its tricuspid regurgitation treatment device, TriClip.
The aim is to evaluate its safety and effectiveness in real-world clinical practice and strengthen the evidence base in the structural heart disease treatment market.
Source
- MedTech Dive
4. Robotic Microsurgery, Expanding Applications for Alzheimer's Disease
Medical Microinstruments (MMI) has received FDA approval to expand its initial trial for Alzheimer's disease treatment using its surgical assistance robot, "Symani".
The application scope of microsurgical robots is expanding from reconstructive surgery to neurological disorders.
Source
- MedTech Dive
https://www.medtechdive.com/news/mmi-to-expand-study-of-robotic-microsurgery-for-alzheimers/826709/
5. Goldman Sachs Acquires Italian Medical Device Manufacturer Numantec
Goldman Sachs Alternatives has announced the acquisition of a controlling stake in the Italian medical device manufacturer, Numantec.
Numantec manufactures drug delivery devices and medical consumables, and its enterprise value is reported to be approximately 700 million euros.
Source
- Reuters
6. KKR Considers Acquiring Integer Holdings
It has been reported that KKR is in advanced talks to acquire Integer Holdings, a major medical device contract development and manufacturing organization.
According to reports, the total acquisition amount is expected to be approximately $4.3 billion.
Integer is known as a contract manufacturer for cardiovascular, neuromodulation, and endovascular devices, among others.
Source
- Reuters
7. Japan: PMDA Announces Multiple Class II Medical Device Recalls
The PMDA has announced multiple Class II recalls, including the following:
- Fetal monitors
- PTA balloon catheters
- Blood/fluid warming tubes
- Denver splints
Medical institutions and distributors are required to check for the affected products.
Source
- PMDA Medical Device Recall Information
https://www.info.pmda.go.jp/kaisyuu/rcidx26-2k.html
8. PMDA Updates Information on Clinical Trials Conducted from a Humanitarian Perspective
On July 31st, the PMDA updated its information regarding clinical trials conducted from a humanitarian perspective.
This includes medical devices and regenerative medicine products, and efforts are underway to expand access within Japan.
Source
- PMDA
https://www.pmda.go.jp/review-services/0001.html
9. Stryker Making Progress on Supply Normalization After Cyberattack
Stryker has reported that its manufacturing and shipping systems are progressively returning to normal following a cyberattack that occurred in March 2026.
While some product supply delays persist, no significant impact on patient-facing products has been confirmed.
Source
- MedTech Dive
10. FDA Medical Device Approvals Increase While Review Times Lengthen
In the first half of 2026, the number of medical device approvals by the FDA is outpacing the previous year.
However, the average review times for 510(k)s and PMAs have become longer than the previous year, indicating a challenge due to insufficient review resources.
Source
- MedTech Dive
Summary
This week, the biggest news was Freenome's FDA approval for its colorectal cancer blood test. The market for cancer screening via blood collection is likely to expand further in the future.
Additionally, investment in the cardiovascular field remained active, with major investments in atrial fibrillation (AF) treatment and post-market studies in structural heart disease.
In M&A, significant investments in the manufacturing and CDMO sectors, such as Numantec and Integer Holdings, continue, indicating strong investment interest across the entire medical device supply chain.
In Japan, PMDA updated recall information and clinical trial information, highlighting the importance of continuous monitoring of safety information and regulatory trends.