Breakthrough Device Designation Archives

Biofourmis Earns FDA’s First-Ever Breakthrough Device Designation for a Novel Digital Therapeutic for Heart Failure

Breakthrough Device Designation, Digital therapeutics, FDA, First-In-Class, Heart Failure, Personalized Care, Pharmacotherapy

Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced July 29 the company’s BiovitalsHF solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration.

July 29, 2021/by Andrew Humphreys

Agilent Adds Liquid Biopsy Assay

Acquisitions, Assays, Breakthrough Device Designation, Business, Diagnostic Tools, Liquid Biopsies, Precision Oncology, Testing, Tissue

Agilent Technologies, expanding on the company’s precision oncology testing, is acquiring Resolution Bioscience.

March 2, 2021/by Andrew Humphreys

FDA clears Roche Epstein-Barr virus test for transplant patients

Breakthrough Device Designation, Cancer, Diagnostic Tests, DNA, Epstein-Barr Virus, FDA, FDA/Regulatory, Transplants

Roche received authorization from the U.S. Food and Drug Administration for the company’s cobas 6800/8800 diagnostic tests for transplant patients.

August 5, 2020/by Andrew Humphreys

Denmark’s Zealand Pharma Places Stalking Horse Bid on Valeritas

Biotechnology, Blood Sugar Control, Breakthrough Device Designation, Business, Chapter 11 Bankruptcy, FDA, Gastrointestinal Diseases, Medical Devices, Metabolic Diseases, Specialty Diseases, Stalking Horse Bid

Copenhagen-based Zealand Pharma announced a bid to buy substantially all the assets from New Jersey-based Valeritas in $23 million in cash and taking on certain liabilities.

February 10, 2020/by BioSpace