Regulatory

Diagnostics

FDA OKs cobas Babesia, Roche's First Whole Blood Test for Donor Screening

If undetected, Babesia infection can be fatal in patients receiving blood transfusions from infected donors.

GlobeNewswire 09.20.19

FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)

FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway.

U.S. Food and Drug Administration 09.20.19

New European Patent Awarded to Motus GI for the Pure-Vu System

The patent strengthens company’s intellectual property estate and supports future international expansion opportunities for the Pure-Vu System.

Business Wire 09.19.19

Cardiovascular

Dassault Systèmes Extends FDA Collaboration on Cardiovascular Device Review Process

Extension aims to spur medical device innovation by enabling innovative, new product designs.

Business Wire 09.18.19

ANVISA Approval Awarded to Cutera's truSculpt Body Sculpting Systems

Research shows the Latin American market for energy-based devices, including body shaping and aesthetics, was $211 million in 2018.

Business Wire 09.18.19

Cardiovascular | Surgical

Orchestra Biomed's Sirolimus-Eluting Balloon Wins Breakthrough Status

The Virtue SEB was awarded Breakthrough Device Designation for the treatment of below-the-knee peripheral artery disease.

GlobeNewswire 09.17.19

Surgical

Gala Therapeutics' Minimally Invasive System for Chronic Bronchitis Gains Breakthrough Status

RheOx uses a minimally invasive procedure to deliver non-thermal energy to the airways to reduce mucus-producing cells in patients with Chronic Bronchitis.

PR Newswire 09.17.19

Cardiovascular | Software & IT | Surgical

FDA OKs HeartFlow's Non-Invasive, Real-Time Virtual Modeling Tool for Coronary Artery Disease

New interactive HeartFlow Planner allows interventional cardiologists to model treatment strategies in real-time before entering the catheterization lab.

Business Wire 09.13.19

Cardiovascular | Surgical

Rex Medical's Revolution Peripheral Atherectomy System Wins FDA Nod

The Revolution device is indicated for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries.

Business Wire 09.13.19

Diagnostics

FDA Clears Qfix's 15-Channel Head Coil for Siemens 3T MRI Systems

The adjustable geometry, 15-Channel coil allows the user to locate the coil elements close to the patient's anatomy.

PR Newswire 09.13.19

3D/Additive Manufacturing | Diagnostics

FDA OKs 3D Systems' D2P Software for Diagnostic Patient-Specific Anatomic Models

Embeds unique volumetric virtual reality (VR) solution enabling instantaneous views of patient scans for enhanced visualization and communication.

PR Newswire 09.13.19

Cardiovascular | Surgical

V-Wave's Interatrial Shunt for Pulmonary Arterial Hypertension Awarded Breakthrough Status

The investigational therapeutic implantable device is placed in the heart through a catheter inserted through a vein in the groin.

PR Newswire 09.13.19

Neurological | Surgical

Checkpoint Surgical's Nerve Regeneration Device Gains Breakthrough Status

The Checkpoint BEST System electrically stimulates peripheral nerves to promote nerve regeneration following injury.

Business Wire 09.12.19

Diagnostics | Software & IT

FDA OKs GE Healthcare's AI-Powered Chest X-ray

Helps radiologists prioritize critical cases with a suspected pneumothorax—a type of collapsed lung.

GE Healthcare 09.12.19

CE Mark Granted to Novian Health for Novilase Breast Therapy

Breast cancer laser therapy offers less invasive alternative to surgery.

Novian Health 09.10.19

Cardiovascular

EBR Systems' WiSE CRT System Gains Breakthrough Status

The WiSE CRT System improves heart’s pumping ability by synchronizing left and right ventricles to distribute blood to lungs and body more effectively.

Business Wire 09.10.19

Diagnostics

Device for Detecting Pre-Cancerous Barrett's Esophagus Receives FDA Clearance

A minimally invasive, cost-effective alternative to endoscopy.

Case Western Reserve University 09.06.19

Cardiovascular | Surgical

Abbott Begins First-Ever Trial of Transcatheter Tricuspid Valve Repair

Abbott's TriClip device was also accepted for national reimbursement consideration through a process known as "Parallel Review" by the FDA and CMS.

Abbott Laboratories 09.06.19

Diagnostics

LAM's Liquid Biopsy Liver Cancer Detection Test Wins Breakthrough Status

Blood-based liquid biopsy test analyzes DNA methylation pattern of cell-free DNA (cfDNA), indicating presence of hepatocellular carcinoma as early as Stage I.

PR Newswire 09.03.19

Cardiovascular | Surgical