Clinical Evidence

OSLO, Norway – November 09, 2026 -- Photocure ASA (OSE: PHO) said the Medicare coverage timeline for its AssureMDx bladder cancer test remains in line with its original acquisition assumptions, after the test was left out of a newly published Novitas Local Coverage Determination (LCD) dated November 6, 2026. Pricing talks, however, point to a potential reimbursement level "meaningfully above" the assumptions in the company's initial underwriting.

Photocure planned for 2028 Medicare coverage when it bought Vesica Health

When Photocure acquired Vesica Health on June 4, 2026, its planning assumption was Medicare coverage in 2028, following submission of additional clinical evidence. A proposed Novitas LCD in May 2026 had raised the prospect of an earlier decision. The final LCD covers urine-based biomarkers in patients with microhematuria but does not include AssureMDx. It identifies additional clinical evidence needed for future reconsideration.

Addison, Texas – November 06, 2026 -- FX Shoulder Solutions has received FDA 510(k) clearance for Easytech Reversed, which the company describes as the first and only stemless reverse shoulder arthroplasty system cleared in the United States. The clearance follows nearly eight years of US clinical investigation.

Seven-site IDE study enrolled 90 patients

FX started the US Investigational Device Exemption (IDE) study in 2018. The multicenter investigation ran across seven sites and covered 90 patients. Follow-up was completed in 2023 and supports the regulatory submission, according to the company. FX also cites more than a decade of international clinical experience with its Easytech technology.

Gothenburg – November 04, 2026 -- Radiotherapy is applied in as few as 12–22% of radically treated prostate cancer patients in some European national registries, even though nearly all men with non-metastatic disease requiring active treatment are candidates for it under European Association of Urology (EAU) guidelines. Clinicians and Swedish medtech firm Micropos Medical are now pushing to raise awareness of high-precision radiotherapy as an alternative to surgery.

GALWAY – November 03, 2026 -- Medtronic's Symplicity Spyral renal denervation (RDN) system cut office systolic blood pressure by 18.2 mmHg at six months in the SPYRAL AFFIRM post-approval study, with no increase in antihypertensive medication. The company also received U.S. FDA approval to update the device's labeling with additional clinical data.

SPYRAL AFFIRM data show significant reductions across three blood pressure measures

Six-month results in the U.S. primary endpoint cohort were compared with a prespecified performance goal. Against baseline, patients recorded the following changes, all at p<0.0001:

Stockholm – October 19, 2026 -- Sobi will present seven accepted abstracts on Aspaveli/Empaveli (pegcetacoplan) at the American Society of Nephrology (ASN) Kidney Week 2026, running 21–25 October in Denver, Colorado, including two oral and five poster presentations.

Oral sessions report 76-week outcomes in two rare kidney diseases

The two oral presentations cover 76-week outcomes with Aspaveli/Empaveli in C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). According to Sobi, the data show maintained proteinuria reduction and stabilised eGFR. The package includes a paediatric subgroup analysis from the VALIANT study and its VALE extension.

Aurora – October 15, 2026 -- Adults with type 2 diabetes who do not take insulin spent about five more hours per day within their target blood sugar range when using continuous glucose monitors (CGMs) than patients receiving routine care, according to a randomized trial published in the New England Journal of Medicine.

Nearly twice as many CGM users reached an A1c below 7%, a common treatment goal. The A1c gap between the two groups was 0.9 percentage points, which the researchers say greatly exceeds the threshold generally considered clinically meaningful.

Trial enrolled 283 adults across 22 primary care practices

Participants were followed for 26 weeks. The University of Colorado Anschutz team describes the study as the first large-scale, multicenter randomized controlled trial to evaluate the effectiveness and safety of CGM in adults with type 2 diabetes who do not take insulin.

TORONTO – October 14, 2026 -- Patients treated with whole-gland TULSA were more than twice as likely to preserve both erectile function and pad-free continence at six months as those who had robotic radical prostatectomy (risk ratio 2.1; p=0.004), according to CAPTAIN trial data. Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) presented the results among five abstracts at the 15th Interventional MRI Symposium in Boston.

CAPTAIN trial shows whole-gland TULSA cut complication hospitalizations to 0.7% versus 6.3% for robotic surgery

CAPTAIN is the first fully enrolled, multicenter randomized controlled trial to compare the TULSA Procedure directly with robotic radical prostatectomy in localized intermediate-risk prostate cancer. Whole-gland TULSA also showed statistically superior preservation of flaccid penile length at one month.

San Carlos, Calif. – October 12, 2026 -- Noah Medical's Galaxy robotic bronchoscopy platform delivered a 96.7% strict diagnostic yield in a 31-patient multi-center study, and an 89% yield with a cost-benefit ratio above 1 in a separate community hospital series, according to two data sets presented at the CHEST 2025 Annual Meeting in Chicago.

MATCH 2 study reports 100% procedural success across 31 patients

The prospective multi-center MATCH 2 study was led by Dr. Amit "Bobby" Mahajan of Inova Fairfax Medical Center in Virginia and Dr. Krish Bhadra of CHI Memorial in Tennessee. Investigators evaluated the Galaxy System's digital tomosynthesis and augmented fluoroscopy algorithms for real-time lesion localization in patients with peripheral pulmonary nodules.

Results across the 31 patients:

San Carlos – October 12, 2026 -- Noah Medical's Galaxy System achieved a 96.7% overall diagnostic yield under a strict definition in the MATCH 2 study, now published online ahead of print in the peer-reviewed journal Respiratory Medicine.

Study tested imaging-guided targeting in 31 patients with peripheral nodules

Thirty-one patients with peripheral pulmonary nodules underwent robotic-assisted bronchoscopy (RAB) with the Galaxy System. Researchers evaluated three-dimensional targeting accuracy using embedded digital tomosynthesis (DT) and integrated augmented fluoroscopy (AF). Cone-beam computed tomography (CBCT), which provides volumetric lung imaging during procedures, was used to confirm tool-in-lesion (TIL) placement.

San Carlos, Calif. – October 12, 2026 -- Noah Medical has created a Chief Pulmonary Advisor role and filled it with Krish Bhadra, MD, an interventional pulmonologist at Stanford Medicine who has performed more than 2,300 robotic-assisted bronchoscopy procedures.

Bhadra to steer clinical education, evidence strategy and product development

In the newly created position, Bhadra will guide Noah Medical's clinical education, evidence strategy and product development. The medical robotics company said the aim is to expand access to advanced robotic bronchoscopy for the millions of patients at risk for lung cancer.

Noah Medical CEO Jian Zhang said the company is scaling the impact of its Galaxy System and called Bhadra "exactly the partner we need" for that effort.