Category: CERTIFICATIONS - Page 8 - Start Medical Product Development

Pattern Bioscience Receives FDA Breakthrough Device Designation for Urine ID/AST Panel

September 22, 2026

Pattern Bioscience, an Austin, Texas-based innovator in rapid diagnostic technologies for bacterial infections, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Urine ID/AST Panel. The panel is the company’s second assay to receive the designation, following the Pneumonia ID/AST Panel, reflecting Pattern’s continued focus on expanding a menu of rapid, direct-from-specimen assays.

Cordis earns FDA nod for Selution SLR drug-eluting balloon

September 22, 2026

Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today.

Anixa Biosciences Granted First Australian Patent for its Breast Cancer Vaccine, Broadening Global Protection Through 2040

September 21, 2026

Composition of matter patent secures exclusive protection for Anixa’s breast cancer vaccine in Australia through 2040, expanding the Company’s growing global IP estate

Mercy BioAnalytics Receives FDA Approval to Initiate Prospective Pivotal Study of Evident™Ovarian Cancer Screening Test

September 21, 2026

IDE approval enables initiation of the pivotal Safety in Ovarian Cancer for Average-Risk Women – Analysis (“SOARA”) Clinical Validation Study following Institutional Review Board approval

Intuitive receives CE mark for transvaginal use of da Vinci SP system

September 20, 2026

The approval allows the da Vinci SP system to be utilised in more women’s health procedures across Europe.

Koning Health Announces Australian Regulatory Approval for Koning Breast CT System

September 18, 2026

NORCROSS, Ga., Sept. 18, 2026 /PRNewswire/ — Koning Health, a global leader in advanced breast imaging technology, today announced that the Koning Breast CT System has been successfully included in the Australian Register of Therapeutic Goods (ARTG), marking an important regulatory milestone for the company’s expansion into the Australian market.

DeepHealth Receives FDA Clearance for Foundation Model-Based Chest X-Ray AI Solution

September 18, 2026

DeepHealth has announced FDA 510(k) clearance for Chest XRay, one of the first FDA-cleared chest X-ray computer-aided detection (CADe) solutions built on a foundation model that detects and localizes suspected thoracic abnormalities on chest radiographs. The clearance marks a significant step in the company’s vision of bringing intelligence into every stage of the imaging experience.

Ultragenyx wins FDA greenlight for first Sanfilippo therapy, priced at nearly $4M

September 18, 2026

The FDA has given the go-ahead to Ultragenyx’s rebisufligene etisparvovec—now to be marketed under the brand name Fayuvi—for the treatment of Sanfilippo syndrome type A, an ulta-rare, progressive neurological condition in children.

Aptitude Announces FDA 510(k) Clearance of Next-Generation Metrix® COVID Test

September 16, 2026

GOLETA, Calif., Sept. 16, 2026 /PRNewswire/ — Aptitude today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the next-generation Metrix® COVID Test, marking the company’s first FDA 510(k) clearance and the continued expansion of the Metrix molecular diagnostics platform. Development was supported by the Biomedical Advanced Research and Development Authority (BARDA).

Medtronic grabs FDA clearance to add LigaSure vessel sealer to Hugo

September 16, 2026

Medtronic (NYSE: MDT) has received an FDA green light to bring its vessel-sealing technology over to its Hugo surgical robot, adding to the platform’s U.S. catalog of energy instruments.